Trial Outcomes & Findings for Novel Respiratory Training as Part of Palliative Care for Older Adults With Heart Failure (NCT NCT06576297)
NCT ID: NCT06576297
Last Updated: 2026-07-17
Results Overview
The number of participants who complete the 3-month assessment is used as a measure of intervention feasibility. Completion of this assessment indicates the feasibility of retaining participants in the study throughout the 3-month intervention period.
COMPLETED
NA
20 participants
3-month
2026-07-17
Participant Flow
20 individuals enrolled in the study, however, 1 participant withdrew from the study prior to assignment.
Participant milestones
| Measure |
Standard of Care
Participants in the usual care group will be telephoned at 4, 8, and 12 weeks for AE/SAE review.
|
IMT Group: Inspiratory Muscle Training (IMT)
Inspiratory Muscle Training (IMT) exercise sessions in addition to standard of care group telephone calls at 4 and 8 weeks, and 12 weeks for AE/SAE review.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
10
|
|
Overall Study
COMPLETED
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Standard of Care
Participants in the usual care group will be telephoned at 4, 8, and 12 weeks for AE/SAE review.
|
IMT Group: Inspiratory Muscle Training (IMT)
Inspiratory Muscle Training (IMT) exercise sessions in addition to standard of care group telephone calls at 4 and 8 weeks, and 12 weeks for AE/SAE review.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
Baseline Characteristics
Novel Respiratory Training as Part of Palliative Care for Older Adults With Heart Failure
Baseline characteristics by cohort
| Measure |
Standard of Care
n=9 Participants
Participants in the standard of care (SOC) group will be telephoned monthly at 4 weeks, 8 weeks, and 12 weeks, and AE/SAE will be reviewed and collected.
|
IMT Group: Inspiratory Muscle Training (IMT)
n=10 Participants
Participants in the Inspiratory Muscle Training (IMT) group will be telephoned monthly at 4 weeks, 8 weeks, and 12 weeks, and AE/SAE will be reviewed and collected.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75.67 Years
STANDARD_DEVIATION 7.25 • n=20 Participants
|
73.10 Years
STANDARD_DEVIATION 3.63 • n=20 Participants
|
74.32 Years
STANDARD_DEVIATION 5.63 • n=40 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
14 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
09 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
17 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
09 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
19 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 3-monthThe number of participants who complete the 3-month assessment is used as a measure of intervention feasibility. Completion of this assessment indicates the feasibility of retaining participants in the study throughout the 3-month intervention period.
Outcome measures
| Measure |
Standard of Care
n=9 Participants
Participants in the usual care group will be telephoned at 4 and 8 weeks, and AE/SAE will be reviewed.
|
IMT Group: Inspiratory Muscle Training (IMT)
n=10 Participants
IMT exercise sessions addition to standard of care.
|
|---|---|---|
|
Completion of 3-month Assessment
|
7 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline to 3-monthsPopulation: Three participants in the IMT Group and three participants in the Standard of Care Group did not complete MIP Testing at the three month data collection visit.
Change in maximum inspiratory pressure (MIP; cmH₂O). MIP is used as an indicator of inspiratory muscle strength
Outcome measures
| Measure |
Standard of Care
n=6 Participants
Participants in the usual care group will be telephoned at 4 and 8 weeks, and AE/SAE will be reviewed.
|
IMT Group: Inspiratory Muscle Training (IMT)
n=7 Participants
IMT exercise sessions addition to standard of care.
|
|---|---|---|
|
Change in MIP (Maximum Inspiratory Pressure)
|
10.50 cmH2O
Standard Deviation 8.09
|
23.00 cmH2O
Standard Deviation 13.22
|
SECONDARY outcome
Timeframe: Baseline to 3-monthsPopulation: Three participants in the IMT Group and two participants in the Standard of Care Group did not complete Sit to Stand Testing at the three month data collection visit.
Change in Sit-to-Stand Time: Time needed to complete 5 Sit-to-Stands from a chair (in seconds).
Outcome measures
| Measure |
Standard of Care
n=7 Participants
Participants in the usual care group will be telephoned at 4 and 8 weeks, and AE/SAE will be reviewed.
|
IMT Group: Inspiratory Muscle Training (IMT)
n=7 Participants
IMT exercise sessions addition to standard of care.
|
|---|---|---|
|
Change in Sit to Stand Time
|
1.43 seconds
Standard Deviation 3.05
|
0.14 seconds
Standard Deviation 0.38
|
SECONDARY outcome
Timeframe: Baseline to 3-monthPopulation: Three participants in the IMT group and two participants in the Standard of Care Group did not complete Gait speed testing at the three-month data collection visit.
4 m Gait Speed: m/sec
Outcome measures
| Measure |
Standard of Care
n=7 Participants
Participants in the usual care group will be telephoned at 4 and 8 weeks, and AE/SAE will be reviewed.
|
IMT Group: Inspiratory Muscle Training (IMT)
n=7 Participants
IMT exercise sessions addition to standard of care.
|
|---|---|---|
|
Change in Gait Speed
|
-0.02 meters/second
Standard Deviation 0.18
|
0.04 meters/second
Standard Deviation 0.14
|
SECONDARY outcome
Timeframe: Baseline to 3-monthPopulation: Three participants in the IMT group and two participants in the Standard of Care Group did not complete the Sullivan Self-Efficacy to Maintain Function Scale at the three-month data collection visit.
Change in the Sullivan Self-Efficacy to Maintain Function Scale: 0-52; higher score is more favorable
Outcome measures
| Measure |
Standard of Care
n=7 Participants
Participants in the usual care group will be telephoned at 4 and 8 weeks, and AE/SAE will be reviewed.
|
IMT Group: Inspiratory Muscle Training (IMT)
n=7 Participants
IMT exercise sessions addition to standard of care.
|
|---|---|---|
|
Change in the Sullivan Self-Efficacy to Maintain Function Scale
|
4.43 score
Standard Deviation 8.46
|
-0.14 score
Standard Deviation 6.28
|
SECONDARY outcome
Timeframe: Baseline to 3-monthPopulation: Three participants in the IMT Group and two participants in the Standard of Care Group did not complete the KCCQ at the three month data collection visit.
Kansas City Cardiomyopathy Questionnaire (KCCQ) to measure quality of life; score: 0-100; higher is more favorable than lower score.
Outcome measures
| Measure |
Standard of Care
n=7 Participants
Participants in the usual care group will be telephoned at 4 and 8 weeks, and AE/SAE will be reviewed.
|
IMT Group: Inspiratory Muscle Training (IMT)
n=7 Participants
IMT exercise sessions addition to standard of care.
|
|---|---|---|
|
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ): Quality of Life Score
|
13.02 score
Standard Deviation 20.75
|
6.77 score
Standard Deviation 14.95
|
SECONDARY outcome
Timeframe: Baseline to 3-monthPopulation: Three participants in the IMT Group and two participants in the Standard of Care Group did not complete the PROMIS survey at the three month data collection visit.
Fatigue: PROMIS Item Bank v1.0 - Fatigue - short form 13a (FACIT-Fatigue): scale 0-52; lower indicates less fatigue.
Outcome measures
| Measure |
Standard of Care
n=7 Participants
Participants in the usual care group will be telephoned at 4 and 8 weeks, and AE/SAE will be reviewed.
|
IMT Group: Inspiratory Muscle Training (IMT)
n=7 Participants
IMT exercise sessions addition to standard of care.
|
|---|---|---|
|
Change in Fatigue
|
-3.83 score
Standard Deviation 6.86
|
-4.54 score
Standard Deviation 6.40
|
SECONDARY outcome
Timeframe: Baseline to 3-monthsPopulation: Three participants in the IMT group and two participants in the Standard of Care Group did not complete gripo strength testing at the three-month data collection visit.
Change in Grip Strength (of dominant hand) in kilograms(kg)
Outcome measures
| Measure |
Standard of Care
n=7 Participants
Participants in the usual care group will be telephoned at 4 and 8 weeks, and AE/SAE will be reviewed.
|
IMT Group: Inspiratory Muscle Training (IMT)
n=7 Participants
IMT exercise sessions addition to standard of care.
|
|---|---|---|
|
Change in Grip Strength: kg
|
28.29 kilogram (kg)
Standard Deviation 9.89
|
32.29 kilogram (kg)
Standard Deviation 15.51
|
Adverse Events
Standard of Care
IMT Group: Inspiratory Muscle Training (IMT)
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