Trial Outcomes & Findings for Smartphone App-guided Inspiratory Muscle Strength Training for Lowering Systolic Blood Pressure (NCT NCT06229873)
NCT ID: NCT06229873
Last Updated: 2026-05-19
Results Overview
Change in systolic blood pressure at rest in the clinic setting
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
33 participants
Primary outcome timeframe
6 weeks
Results posted on
2026-05-19
Participant Flow
Recruitment took place between June 2024 and October 2025. Participants were recruited from Boulder County and the surrounding areas using newspaper advertisements, social media advertisements, and flyers, along with the use of ResearchMatch and BuildClinical.
18 participants were assigned to the App-based group, and 15 participants were assigned to the Clinic-based group. Once enrolled, no participants were excluded from the study before assignment to a group.
Participant milestones
| Measure |
App-Based Inspiratory Muscle Strength Training
Using a handheld device, participants will perform 30 breaths a day, six days a week, for six weeks. Training will be guided by a smartphone application.
|
Clinic-Based Inspiratory Muscle Strength Training
Using a handheld device, participants will perform 30 breaths a day, six days a week, for six weeks. Training will be guided by researchers.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
15
|
|
Overall Study
COMPLETED
|
17
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
App-Based Inspiratory Muscle Strength Training
Using a handheld device, participants will perform 30 breaths a day, six days a week, for six weeks. Training will be guided by a smartphone application.
|
Clinic-Based Inspiratory Muscle Strength Training
Using a handheld device, participants will perform 30 breaths a day, six days a week, for six weeks. Training will be guided by researchers.
|
|---|---|---|
|
Overall Study
Change in medication
|
1
|
0
|
Baseline Characteristics
Smartphone App-guided Inspiratory Muscle Strength Training for Lowering Systolic Blood Pressure
Baseline characteristics by cohort
| Measure |
App-Based Inspiratory Muscle Strength Training
n=17 Participants
Using a handheld device, participants will perform 30 breaths a day, six days a week, for six weeks. Training will be guided by a smartphone application.
|
Clinic-Based Inspiratory Muscle Strength Training
n=15 Participants
Using a handheld device, participants will perform 30 breaths a day, six days a week, for six weeks. Training will be guided by researchers.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 12 • n=30 Participants
|
61 years
STANDARD_DEVIATION 18 • n=30 Participants
|
60 years
STANDARD_DEVIATION 15 • n=60 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=30 Participants
|
7 Participants
n=30 Participants
|
17 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=30 Participants
|
8 Participants
n=30 Participants
|
15 Participants
n=60 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
3 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=30 Participants
|
2 Participants
n=30 Participants
|
2 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=30 Participants
|
12 Participants
n=30 Participants
|
25 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=60 Participants
|
|
Casual systolic blood pressure
|
126 mmHg
STANDARD_DEVIATION 10 • n=30 Participants
|
124 mmHg
STANDARD_DEVIATION 13 • n=30 Participants
|
125 mmHg
STANDARD_DEVIATION 11 • n=60 Participants
|
|
Home systolic blood pressure
|
120 mmHg
STANDARD_DEVIATION 10 • n=30 Participants
|
125 mmHg
STANDARD_DEVIATION 13 • n=30 Participants
|
122 mmHg
STANDARD_DEVIATION 12 • n=60 Participants
|
PRIMARY outcome
Timeframe: 6 weeksChange in systolic blood pressure at rest in the clinic setting
Outcome measures
| Measure |
App-Based Inspiratory Muscle Strength Training
n=17 Participants
Using a handheld device, participants will perform 30 breaths a day, six days a week, for six weeks. Training will be guided by a smartphone application.
|
Clinic-Based Inspiratory Muscle Strength Training
n=15 Participants
Using a handheld device, participants will perform 30 breaths a day, six days a week, for six weeks. Training will be guided by researchers.
|
|---|---|---|
|
Change From Baseline in Casual Systolic Blood Pressure
|
-2 mmHg
Standard Deviation 8
|
0 mmHg
Standard Deviation 7
|
PRIMARY outcome
Timeframe: 6 weeksChange in systolic blood pressure measured at rest in the home
Outcome measures
| Measure |
App-Based Inspiratory Muscle Strength Training
n=16 Participants
Using a handheld device, participants will perform 30 breaths a day, six days a week, for six weeks. Training will be guided by a smartphone application.
|
Clinic-Based Inspiratory Muscle Strength Training
n=15 Participants
Using a handheld device, participants will perform 30 breaths a day, six days a week, for six weeks. Training will be guided by researchers.
|
|---|---|---|
|
Change From Baseline in Home Systolic Blood Pressure
|
2 mmHg
Standard Deviation 8
|
-3 mmHg
Standard Deviation 5
|
SECONDARY outcome
Timeframe: 6 weeksA procedure called brachial artery flow-mediated dilation will be used to assess endothelium-dependent vasodilation. During this procedure a blood pressure cuff will be placed on the forearm and then inflated for 5 minutes to restrict blood flow. During the procedure a video of the brachial artery will be taken with an ultrasound. The video will be analyzed to determine the peak change in the blood vessels diameter. Blood flow response after cuff deflation will also be assessed.
Outcome measures
| Measure |
App-Based Inspiratory Muscle Strength Training
n=17 Participants
Using a handheld device, participants will perform 30 breaths a day, six days a week, for six weeks. Training will be guided by a smartphone application.
|
Clinic-Based Inspiratory Muscle Strength Training
n=13 Participants
Using a handheld device, participants will perform 30 breaths a day, six days a week, for six weeks. Training will be guided by researchers.
|
|---|---|---|
|
Change From Baseline in Endothelial Function
|
-0.5 % change in diameter
Standard Deviation 1.8
|
-0.7 % change in diameter
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: 6 weeksParticipants will use a hand-held breathing device to assess their maximum inspiratory pressure once a week during the intervention. During the maximum inspiratory pressure test, participants will inspire into the device as powerfully as they can. Results from the maximum inspiratory pressure tests will be assessed.
Outcome measures
| Measure |
App-Based Inspiratory Muscle Strength Training
n=15 Participants
Using a handheld device, participants will perform 30 breaths a day, six days a week, for six weeks. Training will be guided by a smartphone application.
|
Clinic-Based Inspiratory Muscle Strength Training
n=15 Participants
Using a handheld device, participants will perform 30 breaths a day, six days a week, for six weeks. Training will be guided by researchers.
|
|---|---|---|
|
Change From Baseline in Maximum Inspiratory Pressure
|
23 mmHg
Standard Deviation 37
|
28 mmHg
Standard Deviation 23
|
SECONDARY outcome
Timeframe: 6 weeksPercentage of days performing inspiratory muscle strength training during the intervention between each group
Outcome measures
| Measure |
App-Based Inspiratory Muscle Strength Training
n=15 Participants
Using a handheld device, participants will perform 30 breaths a day, six days a week, for six weeks. Training will be guided by a smartphone application.
|
Clinic-Based Inspiratory Muscle Strength Training
n=15 Participants
Using a handheld device, participants will perform 30 breaths a day, six days a week, for six weeks. Training will be guided by researchers.
|
|---|---|---|
|
Difference in Adherence to Inspiratory Muscle Strength Training
|
97 Percentage of days
Standard Deviation 9
|
100 Percentage of days
Standard Deviation 7
|
Adverse Events
App-Based Inspiratory Muscle Strength Training
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Clinic-Based Inspiratory Muscle Strength Training
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
App-Based Inspiratory Muscle Strength Training
n=17 participants at risk
Using a handheld device, participants will perform 30 breaths a day, six days a week, for six weeks. Training will be guided by a smartphone application.
|
Clinic-Based Inspiratory Muscle Strength Training
n=15 participants at risk
Using a handheld device, participants will perform 30 breaths a day, six days a week, for six weeks. Training will be guided by researchers.
|
|---|---|---|
|
Blood and lymphatic system disorders
Elevated white blood cell count
|
5.9%
1/17 • From enrollment until last clinical visit, representing an average of 10 weeks.
|
0.00%
0/15 • From enrollment until last clinical visit, representing an average of 10 weeks.
|
|
General disorders
Dizziness
|
0.00%
0/17 • From enrollment until last clinical visit, representing an average of 10 weeks.
|
26.7%
4/15 • From enrollment until last clinical visit, representing an average of 10 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/17 • From enrollment until last clinical visit, representing an average of 10 weeks.
|
6.7%
1/15 • From enrollment until last clinical visit, representing an average of 10 weeks.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/17 • From enrollment until last clinical visit, representing an average of 10 weeks.
|
6.7%
1/15 • From enrollment until last clinical visit, representing an average of 10 weeks.
|
|
Musculoskeletal and connective tissue disorders
Diaphragm pain
|
5.9%
1/17 • From enrollment until last clinical visit, representing an average of 10 weeks.
|
0.00%
0/15 • From enrollment until last clinical visit, representing an average of 10 weeks.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/17 • From enrollment until last clinical visit, representing an average of 10 weeks.
|
6.7%
1/15 • From enrollment until last clinical visit, representing an average of 10 weeks.
|
|
Skin and subcutaneous tissue disorders
Bruise from blood draw
|
0.00%
0/17 • From enrollment until last clinical visit, representing an average of 10 weeks.
|
6.7%
1/15 • From enrollment until last clinical visit, representing an average of 10 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place