Trial Outcomes & Findings for Inspiratory Muscle Training on The Severity of Exercise-Induced Bronchoconstriction and Time-Trial Performance (IMT_EIB) (NCT NCT06336681)
NCT ID: NCT06336681
Last Updated: 2026-05-12
Results Overview
More specifically, the pre- and post-values of the percentage drop in forced expiratory volume in 1 second (FEV1) from the eucapnic voluntary hyperpnea (EVH) test before and after IMT will be measured. Percentage drop in forced expiratory volume in 1 second (FEV1) will be reported in percentages.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
8 weeks
Results posted on
2026-05-12
Participant Flow
Participants were recruited via flyers posted in the School of Public Health and distributed in Kinesiology labs (e.g., SPH-K409, SPH-K535) and other departmental courses. Flyers were also shared on the IU Classifieds website to reach the broader IU community. 15 participants enrolled; 11 completed the study. 4 withdrew or were excluded (EIB criteria not met or training noncompliance). Recruitment occurred from April 2022 to April 2025 at the School of Public Health.
Participant milestones
| Measure |
Inspiratory Muscle Training (IMT) Group
The test protocol requires participants to inhale maximally (maximum inspiratory pressure, MIP) against 2mm diameter leak and sustain inhalation (sustained maximal inspiratory pressure, SMIP) until task failure. Participants will complete 3 SMIP maneuvers with each training session and use the best of the three for that day's training template (corresponding to about 80% SMIP for the IMT group) via the PrO2Fit software. Participants must match or exceed the SMIP template with each increasing level of the work-rest ratio. Work at each level consists of 6 breaths, 36 breaths total. If six breaths are completed, the next level starts. Rest intervals will progressively shorten as training continues from 40-seconds to 5-seconds. The session will be terminated if participants are unable to match at least 90% of the training template for two consecutive breaths or have completed all 36 breaths. Training will be done 3 times a week, and over 8-weeks.
|
Sham Inspiratory Muscle Training (Sham-IMT) Group
Similar to the IMT group protocol, participants will be required to complete 3 SMIP maneuvers with each training session. Participants will use the best of the three for that day's training template (corresponding to about 30% SMIP for the Sham-IMT group) via the PrO2Fit software. Participants must match or exceed the SMIP template with each increasing level of the work-rest ratio. Work at each level consists of 6 breaths, 36 breaths total. If six breaths are completed, the next level starts. Rest intervals will progressively shorten as training continues from 40-seconds to 30-, 20-, 15-, 10-, and 5-seconds. The training session will be terminated if participants are unable to match at least 90% of the training template for two consecutive breaths or have completed all 36 breaths. Training will be done 3 times a week, and over 8-weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
5
|
|
Overall Study
COMPLETED
|
7
|
4
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Inspiratory Muscle Training (IMT) Group
The test protocol requires participants to inhale maximally (maximum inspiratory pressure, MIP) against 2mm diameter leak and sustain inhalation (sustained maximal inspiratory pressure, SMIP) until task failure. Participants will complete 3 SMIP maneuvers with each training session and use the best of the three for that day's training template (corresponding to about 80% SMIP for the IMT group) via the PrO2Fit software. Participants must match or exceed the SMIP template with each increasing level of the work-rest ratio. Work at each level consists of 6 breaths, 36 breaths total. If six breaths are completed, the next level starts. Rest intervals will progressively shorten as training continues from 40-seconds to 5-seconds. The session will be terminated if participants are unable to match at least 90% of the training template for two consecutive breaths or have completed all 36 breaths. Training will be done 3 times a week, and over 8-weeks.
|
Sham Inspiratory Muscle Training (Sham-IMT) Group
Similar to the IMT group protocol, participants will be required to complete 3 SMIP maneuvers with each training session. Participants will use the best of the three for that day's training template (corresponding to about 30% SMIP for the Sham-IMT group) via the PrO2Fit software. Participants must match or exceed the SMIP template with each increasing level of the work-rest ratio. Work at each level consists of 6 breaths, 36 breaths total. If six breaths are completed, the next level starts. Rest intervals will progressively shorten as training continues from 40-seconds to 30-, 20-, 15-, 10-, and 5-seconds. The training session will be terminated if participants are unable to match at least 90% of the training template for two consecutive breaths or have completed all 36 breaths. Training will be done 3 times a week, and over 8-weeks.
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed.
Baseline characteristics by cohort
| Measure |
Inspiratory Muscle Training (IMT) Group
n=10 Participants
The test protocol requires participants to inhale maximally (maximum inspiratory pressure, MIP) against 2mm diameter leak and sustain inhalation (sustained maximal inspiratory pressure, SMIP) until task failure. Participants will complete 3 SMIP maneuvers with each training session and use the best of the three for that day's training template (corresponding to about 80% SMIP for the IMT group) via the PrO2Fit software. Participants must match or exceed the SMIP template with each increasing level of the work-rest ratio. Work at each level consists of 6 breaths, 36 breaths total. If six breaths are completed, the next level starts. Rest intervals will progressively shorten as training continues from 40-seconds to 5-seconds. The session will be terminated if participants are unable to match at least 90% of the training template for two consecutive breaths or have completed all 36 breaths. Training will be done 3 times a week, and over 8-weeks.
|
Sham Inspiratory Muscle Training (Sham-IMT) Group
n=5 Participants
Similar to the IMT group protocol, participants will be required to complete 3 SMIP maneuvers with each training session. Participants will use the best of the three for that day's training template (corresponding to about 30% SMIP for the Sham-IMT group) via the PrO2Fit software. Participants must match or exceed the SMIP template with each increasing level of the work-rest ratio. Work at each level consists of 6 breaths, 36 breaths total. If six breaths are completed, the next level starts. Rest intervals will progressively shorten as training continues from 40-seconds to 30-, 20-, 15-, 10-, and 5-seconds. The training session will be terminated if participants are unable to match at least 90% of the training template for two consecutive breaths or have completed all 36 breaths. Training will be done 3 times a week, and over 8-weeks.
|
Total
n=15 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Customized
Age
|
21.1 Years
STANDARD_DEVIATION 2.2 • n=10 Participants • After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed.
|
21.2 Years
STANDARD_DEVIATION 3.1 • n=5 Participants • After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed.
|
21.1 Years
STANDARD_DEVIATION 2.4 • n=15 Participants • After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed.
|
|
Sex: Female, Male
Female
|
0 Participants
n=10 Participants • After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed.
|
0 Participants
n=5 Participants • After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed.
|
0 Participants
n=15 Participants • After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed.
|
|
Sex: Female, Male
Male
|
10 Participants
n=10 Participants • After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed.
|
5 Participants
n=5 Participants • After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed.
|
15 Participants
n=15 Participants • After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
EIB Severity
|
22.28 Percentage (%)
STANDARD_DEVIATION 13.67 • n=10 Participants • After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed.
|
18.74 Percentage (%)
STANDARD_DEVIATION 6.26 • n=5 Participants • After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed.
|
21.20 Percentage (%)
STANDARD_DEVIATION 11.59 • n=15 Participants • After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed.
|
|
Constant Load 1 Speed
|
23.43 kilometers per hour (kph)
STANDARD_DEVIATION 9.89 • n=10 Participants • After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed.
|
30.73 kilometers per hour (kph)
STANDARD_DEVIATION 5.72 • n=5 Participants • After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed.
|
25.86 kilometers per hour (kph)
STANDARD_DEVIATION 9.21 • n=15 Participants • After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed.
|
|
MIP
|
105.5 centimeters of water (cmH2O)
STANDARD_DEVIATION 32.1 • n=10 Participants • After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed.
|
94.8 centimeters of water (cmH2O)
STANDARD_DEVIATION 12.7 • n=5 Participants • After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed.
|
101.9 centimeters of water (cmH2O)
STANDARD_DEVIATION 27.2 • n=15 Participants • After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed.
|
|
SMIP
|
816.5 pressure time units (ptu)
STANDARD_DEVIATION 208.1 • n=10 Participants • After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed.
|
781.6 pressure time units (ptu)
STANDARD_DEVIATION 336.3 • n=5 Participants • After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed.
|
804.9 pressure time units (ptu)
STANDARD_DEVIATION 245.9 • n=15 Participants • After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed.
|
|
Constant Load 2 Speed
|
22.94 kilometers per hour (kph)
STANDARD_DEVIATION 7.91 • n=10 Participants • After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed.
|
28.03 kilometers per hour (kph)
STANDARD_DEVIATION 8.32 • n=5 Participants • After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed.
|
24.76 kilometers per hour (kph)
STANDARD_DEVIATION 8.14 • n=15 Participants • After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed.
|
|
Time-Trial Time
|
1897.6 seconds (sec)
STANDARD_DEVIATION 295.1 • n=10 Participants • After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed.
|
1645.8 seconds (sec)
STANDARD_DEVIATION 125.3 • n=5 Participants • After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed.
|
1813.7 seconds (sec)
STANDARD_DEVIATION 274.9 • n=15 Participants • After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed.
|
|
Time-Trial Power
|
175.5 Watts (W)
STANDARD_DEVIATION 55.3 • n=10 Participants • After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed.
|
236.1 Watts (W)
STANDARD_DEVIATION 55.5 • n=5 Participants • After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed.
|
195.7 Watts (W)
STANDARD_DEVIATION 61.0 • n=15 Participants • After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed.
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed.
More specifically, the pre- and post-values of the percentage drop in forced expiratory volume in 1 second (FEV1) from the eucapnic voluntary hyperpnea (EVH) test before and after IMT will be measured. Percentage drop in forced expiratory volume in 1 second (FEV1) will be reported in percentages.
Outcome measures
| Measure |
Inspiratory Muscle Training (IMT) Group
n=7 Participants
The test protocol requires participants to inhale maximally (maximum inspiratory pressure, MIP) against 2mm diameter leak and sustain inhalation (sustained maximal inspiratory pressure, SMIP) until task failure. Participants will complete 3 SMIP maneuvers with each training session and use the best of the three for that day's training template (corresponding to about 80% SMIP for the IMT group) via the PrO2Fit software. Participants must match or exceed the SMIP template with each increasing level of the work-rest ratio. Work at each level consists of 6 breaths, 36 breaths total. If six breaths are completed, the next level starts. Rest intervals will progressively shorten as training continues from 40-seconds to 5-seconds. The session will be terminated if participants are unable to match at least 90% of the training template for two consecutive breaths or have completed all 36 breaths. Training will be done 3 times a week, and over 8-weeks.
|
Sham Inspiratory Muscle Training (Sham-IMT) Group
n=4 Participants
Similar to the IMT group protocol, participants will be required to complete 3 SMIP maneuvers with each training session. Participants will use the best of the three for that day's training template (corresponding to about 30% SMIP for the Sham-IMT group) via the PrO2Fit software. Participants must match or exceed the SMIP template with each increasing level of the work-rest ratio. Work at each level consists of 6 breaths, 36 breaths total. If six breaths are completed, the next level starts. Rest intervals will progressively shorten as training continues from 40-seconds to 30-, 20-, 15-, 10-, and 5-seconds. The training session will be terminated if participants are unable to match at least 90% of the training template for two consecutive breaths or have completed all 36 breaths. Training will be done 3 times a week, and over 8-weeks.
|
|---|---|---|
|
Exercise-Induced Bronchoconstriction (EIB) Severity
|
19.84 Percentage (%)
Standard Deviation 12.84
|
10.94 Percentage (%)
Standard Deviation 8.94
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed.
More specifically, the pre- to post-values of maximum inspiratory pressure (reported as cmH2O) before and after IMT will be measured.
Outcome measures
| Measure |
Inspiratory Muscle Training (IMT) Group
n=7 Participants
The test protocol requires participants to inhale maximally (maximum inspiratory pressure, MIP) against 2mm diameter leak and sustain inhalation (sustained maximal inspiratory pressure, SMIP) until task failure. Participants will complete 3 SMIP maneuvers with each training session and use the best of the three for that day's training template (corresponding to about 80% SMIP for the IMT group) via the PrO2Fit software. Participants must match or exceed the SMIP template with each increasing level of the work-rest ratio. Work at each level consists of 6 breaths, 36 breaths total. If six breaths are completed, the next level starts. Rest intervals will progressively shorten as training continues from 40-seconds to 5-seconds. The session will be terminated if participants are unable to match at least 90% of the training template for two consecutive breaths or have completed all 36 breaths. Training will be done 3 times a week, and over 8-weeks.
|
Sham Inspiratory Muscle Training (Sham-IMT) Group
n=4 Participants
Similar to the IMT group protocol, participants will be required to complete 3 SMIP maneuvers with each training session. Participants will use the best of the three for that day's training template (corresponding to about 30% SMIP for the Sham-IMT group) via the PrO2Fit software. Participants must match or exceed the SMIP template with each increasing level of the work-rest ratio. Work at each level consists of 6 breaths, 36 breaths total. If six breaths are completed, the next level starts. Rest intervals will progressively shorten as training continues from 40-seconds to 30-, 20-, 15-, 10-, and 5-seconds. The training session will be terminated if participants are unable to match at least 90% of the training template for two consecutive breaths or have completed all 36 breaths. Training will be done 3 times a week, and over 8-weeks.
|
|---|---|---|
|
Maximum Inspiratory Pressure
|
131.9 cmH2O
Standard Deviation 33.1
|
122.4 cmH2O
Standard Deviation 32.9
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed.
More specifically, the pre- to post-values of sustained maximum inspiratory pressure (reported as pressure time units) before and after IMT will be measured.
Outcome measures
| Measure |
Inspiratory Muscle Training (IMT) Group
n=7 Participants
The test protocol requires participants to inhale maximally (maximum inspiratory pressure, MIP) against 2mm diameter leak and sustain inhalation (sustained maximal inspiratory pressure, SMIP) until task failure. Participants will complete 3 SMIP maneuvers with each training session and use the best of the three for that day's training template (corresponding to about 80% SMIP for the IMT group) via the PrO2Fit software. Participants must match or exceed the SMIP template with each increasing level of the work-rest ratio. Work at each level consists of 6 breaths, 36 breaths total. If six breaths are completed, the next level starts. Rest intervals will progressively shorten as training continues from 40-seconds to 5-seconds. The session will be terminated if participants are unable to match at least 90% of the training template for two consecutive breaths or have completed all 36 breaths. Training will be done 3 times a week, and over 8-weeks.
|
Sham Inspiratory Muscle Training (Sham-IMT) Group
n=4 Participants
Similar to the IMT group protocol, participants will be required to complete 3 SMIP maneuvers with each training session. Participants will use the best of the three for that day's training template (corresponding to about 30% SMIP for the Sham-IMT group) via the PrO2Fit software. Participants must match or exceed the SMIP template with each increasing level of the work-rest ratio. Work at each level consists of 6 breaths, 36 breaths total. If six breaths are completed, the next level starts. Rest intervals will progressively shorten as training continues from 40-seconds to 30-, 20-, 15-, 10-, and 5-seconds. The training session will be terminated if participants are unable to match at least 90% of the training template for two consecutive breaths or have completed all 36 breaths. Training will be done 3 times a week, and over 8-weeks.
|
|---|---|---|
|
Sustained Maximum Inspiratory Pressure
|
978.4 ptu
Standard Deviation 216.8
|
978.8 ptu
Standard Deviation 229.3
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed.
More specifically, differences in 16-km cycling time-trial completion time (seconds) before and after IMT.
Outcome measures
| Measure |
Inspiratory Muscle Training (IMT) Group
n=7 Participants
The test protocol requires participants to inhale maximally (maximum inspiratory pressure, MIP) against 2mm diameter leak and sustain inhalation (sustained maximal inspiratory pressure, SMIP) until task failure. Participants will complete 3 SMIP maneuvers with each training session and use the best of the three for that day's training template (corresponding to about 80% SMIP for the IMT group) via the PrO2Fit software. Participants must match or exceed the SMIP template with each increasing level of the work-rest ratio. Work at each level consists of 6 breaths, 36 breaths total. If six breaths are completed, the next level starts. Rest intervals will progressively shorten as training continues from 40-seconds to 5-seconds. The session will be terminated if participants are unable to match at least 90% of the training template for two consecutive breaths or have completed all 36 breaths. Training will be done 3 times a week, and over 8-weeks.
|
Sham Inspiratory Muscle Training (Sham-IMT) Group
n=4 Participants
Similar to the IMT group protocol, participants will be required to complete 3 SMIP maneuvers with each training session. Participants will use the best of the three for that day's training template (corresponding to about 30% SMIP for the Sham-IMT group) via the PrO2Fit software. Participants must match or exceed the SMIP template with each increasing level of the work-rest ratio. Work at each level consists of 6 breaths, 36 breaths total. If six breaths are completed, the next level starts. Rest intervals will progressively shorten as training continues from 40-seconds to 30-, 20-, 15-, 10-, and 5-seconds. The training session will be terminated if participants are unable to match at least 90% of the training template for two consecutive breaths or have completed all 36 breaths. Training will be done 3 times a week, and over 8-weeks.
|
|---|---|---|
|
16-km Cycling Time-Trial Time to Completion
|
1900 Seconds (sec)
Standard Deviation 263
|
1668 Seconds (sec)
Standard Deviation 39
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed.
More specifically, differences in 16-km cycling time-trial power output (watts) before and after IMT.
Outcome measures
| Measure |
Inspiratory Muscle Training (IMT) Group
n=7 Participants
The test protocol requires participants to inhale maximally (maximum inspiratory pressure, MIP) against 2mm diameter leak and sustain inhalation (sustained maximal inspiratory pressure, SMIP) until task failure. Participants will complete 3 SMIP maneuvers with each training session and use the best of the three for that day's training template (corresponding to about 80% SMIP for the IMT group) via the PrO2Fit software. Participants must match or exceed the SMIP template with each increasing level of the work-rest ratio. Work at each level consists of 6 breaths, 36 breaths total. If six breaths are completed, the next level starts. Rest intervals will progressively shorten as training continues from 40-seconds to 5-seconds. The session will be terminated if participants are unable to match at least 90% of the training template for two consecutive breaths or have completed all 36 breaths. Training will be done 3 times a week, and over 8-weeks.
|
Sham Inspiratory Muscle Training (Sham-IMT) Group
n=4 Participants
Similar to the IMT group protocol, participants will be required to complete 3 SMIP maneuvers with each training session. Participants will use the best of the three for that day's training template (corresponding to about 30% SMIP for the Sham-IMT group) via the PrO2Fit software. Participants must match or exceed the SMIP template with each increasing level of the work-rest ratio. Work at each level consists of 6 breaths, 36 breaths total. If six breaths are completed, the next level starts. Rest intervals will progressively shorten as training continues from 40-seconds to 30-, 20-, 15-, 10-, and 5-seconds. The training session will be terminated if participants are unable to match at least 90% of the training template for two consecutive breaths or have completed all 36 breaths. Training will be done 3 times a week, and over 8-weeks.
|
|---|---|---|
|
16-km Cycling Time-Trial Power Output
|
171.9 Watts (W)
Standard Deviation 57.4
|
221.8 Watts (W)
Standard Deviation 13.6
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: After arm assignment, 1 participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; was excluded. 2 participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. 1 additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed.
More specifically, differences in constant load performance (i.e., speed) before and after IMT.
Outcome measures
| Measure |
Inspiratory Muscle Training (IMT) Group
n=7 Participants
The test protocol requires participants to inhale maximally (maximum inspiratory pressure, MIP) against 2mm diameter leak and sustain inhalation (sustained maximal inspiratory pressure, SMIP) until task failure. Participants will complete 3 SMIP maneuvers with each training session and use the best of the three for that day's training template (corresponding to about 80% SMIP for the IMT group) via the PrO2Fit software. Participants must match or exceed the SMIP template with each increasing level of the work-rest ratio. Work at each level consists of 6 breaths, 36 breaths total. If six breaths are completed, the next level starts. Rest intervals will progressively shorten as training continues from 40-seconds to 5-seconds. The session will be terminated if participants are unable to match at least 90% of the training template for two consecutive breaths or have completed all 36 breaths. Training will be done 3 times a week, and over 8-weeks.
|
Sham Inspiratory Muscle Training (Sham-IMT) Group
n=4 Participants
Similar to the IMT group protocol, participants will be required to complete 3 SMIP maneuvers with each training session. Participants will use the best of the three for that day's training template (corresponding to about 30% SMIP for the Sham-IMT group) via the PrO2Fit software. Participants must match or exceed the SMIP template with each increasing level of the work-rest ratio. Work at each level consists of 6 breaths, 36 breaths total. If six breaths are completed, the next level starts. Rest intervals will progressively shorten as training continues from 40-seconds to 30-, 20-, 15-, 10-, and 5-seconds. The training session will be terminated if participants are unable to match at least 90% of the training template for two consecutive breaths or have completed all 36 breaths. Training will be done 3 times a week, and over 8-weeks.
|
|---|---|---|
|
Constant Load 1 and 2 Speed
Constant Load 1 (15% Below GET)
|
26.6 kilometers per hour (kph)
Standard Deviation 7.0
|
35.9 kilometers per hour (kph)
Standard Deviation 6.7
|
|
Constant Load 1 and 2 Speed
Constant Load 2 (15% Above GET)
|
25.8 kilometers per hour (kph)
Standard Deviation 5.6
|
33.4 kilometers per hour (kph)
Standard Deviation 9.9
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed.
More specifically, whether IMT affects an individual's perception of exertional dyspnea (revised Borg Scales from 0-10 to rate breathing intensity and unpleasantness) and revised Borg Scales from 0-10 to rate leg fatigue during constant load 1 (CL1) cycling. Scores will be reported as whole numbers between 0-10. Higher scores indicate extreme intensity, unpleasantness, or fatigue.
Outcome measures
| Measure |
Inspiratory Muscle Training (IMT) Group
n=7 Participants
The test protocol requires participants to inhale maximally (maximum inspiratory pressure, MIP) against 2mm diameter leak and sustain inhalation (sustained maximal inspiratory pressure, SMIP) until task failure. Participants will complete 3 SMIP maneuvers with each training session and use the best of the three for that day's training template (corresponding to about 80% SMIP for the IMT group) via the PrO2Fit software. Participants must match or exceed the SMIP template with each increasing level of the work-rest ratio. Work at each level consists of 6 breaths, 36 breaths total. If six breaths are completed, the next level starts. Rest intervals will progressively shorten as training continues from 40-seconds to 5-seconds. The session will be terminated if participants are unable to match at least 90% of the training template for two consecutive breaths or have completed all 36 breaths. Training will be done 3 times a week, and over 8-weeks.
|
Sham Inspiratory Muscle Training (Sham-IMT) Group
n=4 Participants
Similar to the IMT group protocol, participants will be required to complete 3 SMIP maneuvers with each training session. Participants will use the best of the three for that day's training template (corresponding to about 30% SMIP for the Sham-IMT group) via the PrO2Fit software. Participants must match or exceed the SMIP template with each increasing level of the work-rest ratio. Work at each level consists of 6 breaths, 36 breaths total. If six breaths are completed, the next level starts. Rest intervals will progressively shorten as training continues from 40-seconds to 30-, 20-, 15-, 10-, and 5-seconds. The training session will be terminated if participants are unable to match at least 90% of the training template for two consecutive breaths or have completed all 36 breaths. Training will be done 3 times a week, and over 8-weeks.
|
|---|---|---|
|
Perception of Breathing Intensity, Unpleasantness, and Leg Fatigue During Constant Load 1
Baseline - Dyspnea Intensity
|
3.75 units on a scale
Standard Deviation 1.61
|
3.94 units on a scale
Standard Deviation 0.72
|
|
Perception of Breathing Intensity, Unpleasantness, and Leg Fatigue During Constant Load 1
Post-training - Dyspnea Intensity
|
2.86 units on a scale
Standard Deviation 1.61
|
3.25 units on a scale
Standard Deviation 1.06
|
|
Perception of Breathing Intensity, Unpleasantness, and Leg Fatigue During Constant Load 1
Baseline - Dyspnea Unpleasantness
|
3.25 units on a scale
Standard Deviation 1.35
|
3.06 units on a scale
Standard Deviation 1.11
|
|
Perception of Breathing Intensity, Unpleasantness, and Leg Fatigue During Constant Load 1
Post-training - Dyspnea Unpleasantness
|
2.46 units on a scale
Standard Deviation 1.60
|
2.50 units on a scale
Standard Deviation 1.37
|
|
Perception of Breathing Intensity, Unpleasantness, and Leg Fatigue During Constant Load 1
Baseline - Leg Fatigue
|
4.25 units on a scale
Standard Deviation 2.23
|
4.31 units on a scale
Standard Deviation 1.07
|
|
Perception of Breathing Intensity, Unpleasantness, and Leg Fatigue During Constant Load 1
Post-training - Leg Fatigue
|
3.43 units on a scale
Standard Deviation 1.22
|
3.81 units on a scale
Standard Deviation 1.55
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: After arm assignment, 1 participant ceased communication, they were not training and did not respond to scheduling attempts; excluded. 2 participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. 1 participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT=7 and Sham-IMT=4 fully completed. Baseline CL2 participant numbers were IMT=6 and Sham-IMT=4.
More specifically, whether IMT affects an individual's perception of exertional dyspnea (revised Borg Scales from 0-10 to rate breathing intensity and unpleasantness) and revised Borg Scales from 0-10 to rate leg fatigue during constant load 2 (CL2) cycling. Scores will be reported as whole numbers between 0-10. Higher scores indicate extreme intensity, unpleasantness, or fatigue.
Outcome measures
| Measure |
Inspiratory Muscle Training (IMT) Group
n=7 Participants
The test protocol requires participants to inhale maximally (maximum inspiratory pressure, MIP) against 2mm diameter leak and sustain inhalation (sustained maximal inspiratory pressure, SMIP) until task failure. Participants will complete 3 SMIP maneuvers with each training session and use the best of the three for that day's training template (corresponding to about 80% SMIP for the IMT group) via the PrO2Fit software. Participants must match or exceed the SMIP template with each increasing level of the work-rest ratio. Work at each level consists of 6 breaths, 36 breaths total. If six breaths are completed, the next level starts. Rest intervals will progressively shorten as training continues from 40-seconds to 5-seconds. The session will be terminated if participants are unable to match at least 90% of the training template for two consecutive breaths or have completed all 36 breaths. Training will be done 3 times a week, and over 8-weeks.
|
Sham Inspiratory Muscle Training (Sham-IMT) Group
n=4 Participants
Similar to the IMT group protocol, participants will be required to complete 3 SMIP maneuvers with each training session. Participants will use the best of the three for that day's training template (corresponding to about 30% SMIP for the Sham-IMT group) via the PrO2Fit software. Participants must match or exceed the SMIP template with each increasing level of the work-rest ratio. Work at each level consists of 6 breaths, 36 breaths total. If six breaths are completed, the next level starts. Rest intervals will progressively shorten as training continues from 40-seconds to 30-, 20-, 15-, 10-, and 5-seconds. The training session will be terminated if participants are unable to match at least 90% of the training template for two consecutive breaths or have completed all 36 breaths. Training will be done 3 times a week, and over 8-weeks.
|
|---|---|---|
|
Perception of Breathing Intensity, Unpleasantness, and Leg Fatigue During Constant Load 2
Baseline - Dyspnea Intensity
|
5.71 units on a scale
Standard Deviation 2.60
|
7.06 units on a scale
Standard Deviation 1.01
|
|
Perception of Breathing Intensity, Unpleasantness, and Leg Fatigue During Constant Load 2
Post-training - Dyspnea Intensity
|
4.79 units on a scale
Standard Deviation 2.70
|
5.17 units on a scale
Standard Deviation 1.47
|
|
Perception of Breathing Intensity, Unpleasantness, and Leg Fatigue During Constant Load 2
Baseline - Dyspnea Unpleasantness
|
5.13 units on a scale
Standard Deviation 2.84
|
6.19 units on a scale
Standard Deviation 1.66
|
|
Perception of Breathing Intensity, Unpleasantness, and Leg Fatigue During Constant Load 2
Post-training - Dyspnea Unpleasantness
|
4.50 units on a scale
Standard Deviation 2.74
|
4.60 units on a scale
Standard Deviation 1.46
|
|
Perception of Breathing Intensity, Unpleasantness, and Leg Fatigue During Constant Load 2
Baseline - Leg Fatigue
|
5.71 units on a scale
Standard Deviation 2.27
|
7.06 units on a scale
Standard Deviation 0.88
|
|
Perception of Breathing Intensity, Unpleasantness, and Leg Fatigue During Constant Load 2
Post-training - Leg Fatigue
|
5.29 units on a scale
Standard Deviation 2.45
|
5.69 units on a scale
Standard Deviation 1.76
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed.
More specifically, whether IMT affects an individual's perception of exertional dyspnea (revised Borg Scales from 0-10 to rate breathing intensity and unpleasantness) and revised Borg Scales from 0-10 to rate leg fatigue during a 16-km cycling time-trial. Scores will be reported as whole numbers between 0-10. Higher scores indicate extreme intensity, unpleasantness, or fatigue.
Outcome measures
| Measure |
Inspiratory Muscle Training (IMT) Group
n=7 Participants
The test protocol requires participants to inhale maximally (maximum inspiratory pressure, MIP) against 2mm diameter leak and sustain inhalation (sustained maximal inspiratory pressure, SMIP) until task failure. Participants will complete 3 SMIP maneuvers with each training session and use the best of the three for that day's training template (corresponding to about 80% SMIP for the IMT group) via the PrO2Fit software. Participants must match or exceed the SMIP template with each increasing level of the work-rest ratio. Work at each level consists of 6 breaths, 36 breaths total. If six breaths are completed, the next level starts. Rest intervals will progressively shorten as training continues from 40-seconds to 5-seconds. The session will be terminated if participants are unable to match at least 90% of the training template for two consecutive breaths or have completed all 36 breaths. Training will be done 3 times a week, and over 8-weeks.
|
Sham Inspiratory Muscle Training (Sham-IMT) Group
n=4 Participants
Similar to the IMT group protocol, participants will be required to complete 3 SMIP maneuvers with each training session. Participants will use the best of the three for that day's training template (corresponding to about 30% SMIP for the Sham-IMT group) via the PrO2Fit software. Participants must match or exceed the SMIP template with each increasing level of the work-rest ratio. Work at each level consists of 6 breaths, 36 breaths total. If six breaths are completed, the next level starts. Rest intervals will progressively shorten as training continues from 40-seconds to 30-, 20-, 15-, 10-, and 5-seconds. The training session will be terminated if participants are unable to match at least 90% of the training template for two consecutive breaths or have completed all 36 breaths. Training will be done 3 times a week, and over 8-weeks.
|
|---|---|---|
|
Perception of Breathing Intensity, Unpleasantness, and Leg Fatigue During Time-Trial Cycling
Baseline - Dyspnea Intensity
|
4.89 units on a scale
Standard Deviation 2.26
|
5.75 units on a scale
Standard Deviation 1.83
|
|
Perception of Breathing Intensity, Unpleasantness, and Leg Fatigue During Time-Trial Cycling
Post-training - Dyspnea Intensity
|
4.71 units on a scale
Standard Deviation 2.19
|
5.38 units on a scale
Standard Deviation 1.96
|
|
Perception of Breathing Intensity, Unpleasantness, and Leg Fatigue During Time-Trial Cycling
Baseline - Dyspnea Unpleasantness
|
4.50 units on a scale
Standard Deviation 2.35
|
5.25 units on a scale
Standard Deviation 2.25
|
|
Perception of Breathing Intensity, Unpleasantness, and Leg Fatigue During Time-Trial Cycling
Post-training - Dyspnea Unpleasantness
|
3.89 units on a scale
Standard Deviation 2.45
|
4.31 units on a scale
Standard Deviation 1.78
|
|
Perception of Breathing Intensity, Unpleasantness, and Leg Fatigue During Time-Trial Cycling
Baseline - Leg Fatigue
|
5.57 units on a scale
Standard Deviation 1.94
|
6.56 units on a scale
Standard Deviation 1.75
|
|
Perception of Breathing Intensity, Unpleasantness, and Leg Fatigue During Time-Trial Cycling
Post-training - Leg Fatigue
|
5.64 units on a scale
Standard Deviation 2.17
|
6.63 units on a scale
Standard Deviation 1.53
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed.
More specifically, the effects of IMT on the deoxygenation (HHb) of the respiratory (RM) and limb locomotor muscles (LM) during constant load 1 (CL1) cycling
Outcome measures
| Measure |
Inspiratory Muscle Training (IMT) Group
n=7 Participants
The test protocol requires participants to inhale maximally (maximum inspiratory pressure, MIP) against 2mm diameter leak and sustain inhalation (sustained maximal inspiratory pressure, SMIP) until task failure. Participants will complete 3 SMIP maneuvers with each training session and use the best of the three for that day's training template (corresponding to about 80% SMIP for the IMT group) via the PrO2Fit software. Participants must match or exceed the SMIP template with each increasing level of the work-rest ratio. Work at each level consists of 6 breaths, 36 breaths total. If six breaths are completed, the next level starts. Rest intervals will progressively shorten as training continues from 40-seconds to 5-seconds. The session will be terminated if participants are unable to match at least 90% of the training template for two consecutive breaths or have completed all 36 breaths. Training will be done 3 times a week, and over 8-weeks.
|
Sham Inspiratory Muscle Training (Sham-IMT) Group
n=4 Participants
Similar to the IMT group protocol, participants will be required to complete 3 SMIP maneuvers with each training session. Participants will use the best of the three for that day's training template (corresponding to about 30% SMIP for the Sham-IMT group) via the PrO2Fit software. Participants must match or exceed the SMIP template with each increasing level of the work-rest ratio. Work at each level consists of 6 breaths, 36 breaths total. If six breaths are completed, the next level starts. Rest intervals will progressively shorten as training continues from 40-seconds to 30-, 20-, 15-, 10-, and 5-seconds. The training session will be terminated if participants are unable to match at least 90% of the training template for two consecutive breaths or have completed all 36 breaths. Training will be done 3 times a week, and over 8-weeks.
|
|---|---|---|
|
Deoxygenation of the Respiratory and Limb Locomotor Muscles During Constant Load 1
Baseline - HHb RM
|
6.19 micromolar (uM)
Standard Deviation 4.80
|
6.44 micromolar (uM)
Standard Deviation 2.35
|
|
Deoxygenation of the Respiratory and Limb Locomotor Muscles During Constant Load 1
Post-training - HHb RM
|
2.30 micromolar (uM)
Standard Deviation 4.39
|
5.45 micromolar (uM)
Standard Deviation 4.60
|
|
Deoxygenation of the Respiratory and Limb Locomotor Muscles During Constant Load 1
Post-training - HHb LM
|
8.29 micromolar (uM)
Standard Deviation 6.24
|
13.62 micromolar (uM)
Standard Deviation 9.68
|
|
Deoxygenation of the Respiratory and Limb Locomotor Muscles During Constant Load 1
Baseline - HHb LM
|
5.50 micromolar (uM)
Standard Deviation 2.84
|
7.57 micromolar (uM)
Standard Deviation 10.62
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: After arm assignment, 1 participant ceased communication, they were not training and did not respond to scheduling attempts; excluded. 2 participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. 1 participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT=7 and Sham-IMT=4 fully completed. Baseline CL2 participant numbers were IMT=6 and Sham-IMT=4.
More specifically, the effects of IMT on the deoxygenation of the respiratory and limb locomotor muscles during constant load 2 (CL2) cycling
Outcome measures
| Measure |
Inspiratory Muscle Training (IMT) Group
n=7 Participants
The test protocol requires participants to inhale maximally (maximum inspiratory pressure, MIP) against 2mm diameter leak and sustain inhalation (sustained maximal inspiratory pressure, SMIP) until task failure. Participants will complete 3 SMIP maneuvers with each training session and use the best of the three for that day's training template (corresponding to about 80% SMIP for the IMT group) via the PrO2Fit software. Participants must match or exceed the SMIP template with each increasing level of the work-rest ratio. Work at each level consists of 6 breaths, 36 breaths total. If six breaths are completed, the next level starts. Rest intervals will progressively shorten as training continues from 40-seconds to 5-seconds. The session will be terminated if participants are unable to match at least 90% of the training template for two consecutive breaths or have completed all 36 breaths. Training will be done 3 times a week, and over 8-weeks.
|
Sham Inspiratory Muscle Training (Sham-IMT) Group
n=4 Participants
Similar to the IMT group protocol, participants will be required to complete 3 SMIP maneuvers with each training session. Participants will use the best of the three for that day's training template (corresponding to about 30% SMIP for the Sham-IMT group) via the PrO2Fit software. Participants must match or exceed the SMIP template with each increasing level of the work-rest ratio. Work at each level consists of 6 breaths, 36 breaths total. If six breaths are completed, the next level starts. Rest intervals will progressively shorten as training continues from 40-seconds to 30-, 20-, 15-, 10-, and 5-seconds. The training session will be terminated if participants are unable to match at least 90% of the training template for two consecutive breaths or have completed all 36 breaths. Training will be done 3 times a week, and over 8-weeks.
|
|---|---|---|
|
Deoxygenation of the Respiratory and Limb Locomotor Muscles During Constant Load 2
Baseline - HHb LM
|
9.07 micromolar (uM)
Standard Deviation 4.05
|
17.49 micromolar (uM)
Standard Deviation 8.85
|
|
Deoxygenation of the Respiratory and Limb Locomotor Muscles During Constant Load 2
Post-training - HHb LM
|
10.58 micromolar (uM)
Standard Deviation 5.58
|
15.97 micromolar (uM)
Standard Deviation 8.55
|
|
Deoxygenation of the Respiratory and Limb Locomotor Muscles During Constant Load 2
Baseline - HHb RM
|
7.93 micromolar (uM)
Standard Deviation 3.40
|
12.19 micromolar (uM)
Standard Deviation 9.09
|
|
Deoxygenation of the Respiratory and Limb Locomotor Muscles During Constant Load 2
Post-training - HHb RM
|
6.87 micromolar (uM)
Standard Deviation 6.53
|
12.95 micromolar (uM)
Standard Deviation 8.11
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed.
More specifically, the effects of IMT on the deoxygenation of the respiratory and limb locomotor muscles during a 16-km cycling time-trial
Outcome measures
| Measure |
Inspiratory Muscle Training (IMT) Group
n=7 Participants
The test protocol requires participants to inhale maximally (maximum inspiratory pressure, MIP) against 2mm diameter leak and sustain inhalation (sustained maximal inspiratory pressure, SMIP) until task failure. Participants will complete 3 SMIP maneuvers with each training session and use the best of the three for that day's training template (corresponding to about 80% SMIP for the IMT group) via the PrO2Fit software. Participants must match or exceed the SMIP template with each increasing level of the work-rest ratio. Work at each level consists of 6 breaths, 36 breaths total. If six breaths are completed, the next level starts. Rest intervals will progressively shorten as training continues from 40-seconds to 5-seconds. The session will be terminated if participants are unable to match at least 90% of the training template for two consecutive breaths or have completed all 36 breaths. Training will be done 3 times a week, and over 8-weeks.
|
Sham Inspiratory Muscle Training (Sham-IMT) Group
n=4 Participants
Similar to the IMT group protocol, participants will be required to complete 3 SMIP maneuvers with each training session. Participants will use the best of the three for that day's training template (corresponding to about 30% SMIP for the Sham-IMT group) via the PrO2Fit software. Participants must match or exceed the SMIP template with each increasing level of the work-rest ratio. Work at each level consists of 6 breaths, 36 breaths total. If six breaths are completed, the next level starts. Rest intervals will progressively shorten as training continues from 40-seconds to 30-, 20-, 15-, 10-, and 5-seconds. The training session will be terminated if participants are unable to match at least 90% of the training template for two consecutive breaths or have completed all 36 breaths. Training will be done 3 times a week, and over 8-weeks.
|
|---|---|---|
|
Deoxygenation of the Respiratory and Limb Locomotor Muscles During Time-Trial Cycling
Baseline - HHb LM
|
10.58 micromolar (uM)
Standard Deviation 8.11
|
14.19 micromolar (uM)
Standard Deviation 9.54
|
|
Deoxygenation of the Respiratory and Limb Locomotor Muscles During Time-Trial Cycling
Post-training - HHb LM
|
10.89 micromolar (uM)
Standard Deviation 7.43
|
13.25 micromolar (uM)
Standard Deviation 7.40
|
|
Deoxygenation of the Respiratory and Limb Locomotor Muscles During Time-Trial Cycling
Baseline - HHb RM
|
6.40 micromolar (uM)
Standard Deviation 6.03
|
14.25 micromolar (uM)
Standard Deviation 5.43
|
|
Deoxygenation of the Respiratory and Limb Locomotor Muscles During Time-Trial Cycling
Post-training - HHb RM
|
4.33 micromolar (uM)
Standard Deviation 5.63
|
8.94 micromolar (uM)
Standard Deviation 3.32
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: After arm assignment, one participant ceased communication following emails indicating they were not training and did not respond to scheduling attempts; this individual was excluded. Two participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. One additional participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT = 7 and Sham-IMT = 4 for fully completed.
More specifically, the effects of IMT on femoral blood flow (FBF) of the limb locomotor muscles during constant load 1 (CL1) cycling
Outcome measures
| Measure |
Inspiratory Muscle Training (IMT) Group
n=7 Participants
The test protocol requires participants to inhale maximally (maximum inspiratory pressure, MIP) against 2mm diameter leak and sustain inhalation (sustained maximal inspiratory pressure, SMIP) until task failure. Participants will complete 3 SMIP maneuvers with each training session and use the best of the three for that day's training template (corresponding to about 80% SMIP for the IMT group) via the PrO2Fit software. Participants must match or exceed the SMIP template with each increasing level of the work-rest ratio. Work at each level consists of 6 breaths, 36 breaths total. If six breaths are completed, the next level starts. Rest intervals will progressively shorten as training continues from 40-seconds to 5-seconds. The session will be terminated if participants are unable to match at least 90% of the training template for two consecutive breaths or have completed all 36 breaths. Training will be done 3 times a week, and over 8-weeks.
|
Sham Inspiratory Muscle Training (Sham-IMT) Group
n=4 Participants
Similar to the IMT group protocol, participants will be required to complete 3 SMIP maneuvers with each training session. Participants will use the best of the three for that day's training template (corresponding to about 30% SMIP for the Sham-IMT group) via the PrO2Fit software. Participants must match or exceed the SMIP template with each increasing level of the work-rest ratio. Work at each level consists of 6 breaths, 36 breaths total. If six breaths are completed, the next level starts. Rest intervals will progressively shorten as training continues from 40-seconds to 30-, 20-, 15-, 10-, and 5-seconds. The training session will be terminated if participants are unable to match at least 90% of the training template for two consecutive breaths or have completed all 36 breaths. Training will be done 3 times a week, and over 8-weeks.
|
|---|---|---|
|
Femoral Blood Flow of the Limb Locomotor Muscles During Constant Load 1
Baseline - FBF
|
9384.32 millimeters per minute (mL/min)
Standard Deviation 5889.62
|
9055.95 millimeters per minute (mL/min)
Standard Deviation 4048.40
|
|
Femoral Blood Flow of the Limb Locomotor Muscles During Constant Load 1
Post-training - FBF
|
10255.24 millimeters per minute (mL/min)
Standard Deviation 7543.17
|
11687.37 millimeters per minute (mL/min)
Standard Deviation 3467.06
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: After arm assignment, 1 participant ceased communication, they were not training and did not respond to scheduling attempts; excluded. 2 participants reported inconsistent training and subsequently stopped responding to follow-up communications and were excluded. 1 participant did not adhere to the prescribed training protocol and was excluded for noncompliance. This led to IMT=7 and Sham-IMT=4 fully completed. Baseline CL2 participant numbers were IMT=6 and Sham-IMT=4.
More specifically, the effects of IMT on femoral blood flow (FBF) of the limb locomotor muscles during constant load 2 (CL2) cycling
Outcome measures
| Measure |
Inspiratory Muscle Training (IMT) Group
n=7 Participants
The test protocol requires participants to inhale maximally (maximum inspiratory pressure, MIP) against 2mm diameter leak and sustain inhalation (sustained maximal inspiratory pressure, SMIP) until task failure. Participants will complete 3 SMIP maneuvers with each training session and use the best of the three for that day's training template (corresponding to about 80% SMIP for the IMT group) via the PrO2Fit software. Participants must match or exceed the SMIP template with each increasing level of the work-rest ratio. Work at each level consists of 6 breaths, 36 breaths total. If six breaths are completed, the next level starts. Rest intervals will progressively shorten as training continues from 40-seconds to 5-seconds. The session will be terminated if participants are unable to match at least 90% of the training template for two consecutive breaths or have completed all 36 breaths. Training will be done 3 times a week, and over 8-weeks.
|
Sham Inspiratory Muscle Training (Sham-IMT) Group
n=4 Participants
Similar to the IMT group protocol, participants will be required to complete 3 SMIP maneuvers with each training session. Participants will use the best of the three for that day's training template (corresponding to about 30% SMIP for the Sham-IMT group) via the PrO2Fit software. Participants must match or exceed the SMIP template with each increasing level of the work-rest ratio. Work at each level consists of 6 breaths, 36 breaths total. If six breaths are completed, the next level starts. Rest intervals will progressively shorten as training continues from 40-seconds to 30-, 20-, 15-, 10-, and 5-seconds. The training session will be terminated if participants are unable to match at least 90% of the training template for two consecutive breaths or have completed all 36 breaths. Training will be done 3 times a week, and over 8-weeks.
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|---|---|---|
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Femoral Blood Flow of the Limb Locomotor Muscles During Constant Load 2
Baseline - FBF
|
14970.14 milliliters per minute (mL/min)
Standard Deviation 6856.73
|
13760.42 milliliters per minute (mL/min)
Standard Deviation 4047.17
|
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Femoral Blood Flow of the Limb Locomotor Muscles During Constant Load 2
Post-training - FBF
|
8608.25 milliliters per minute (mL/min)
Standard Deviation 5294.61
|
15903.34 milliliters per minute (mL/min)
Standard Deviation 9318.82
|
Adverse Events
Inspiratory Muscle Training (IMT) Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Inspiratory Muscle Training (Sham-IMT) Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place