Trial Outcomes & Findings for High-intensity Inspiratory Muscle Training as a Pre-cardiac Rehabilitation in Heart Disease (NCT NCT06127147)
NCT ID: NCT06127147
Last Updated: 2026-01-21
Results Overview
maximal inspiratory pressure (MIP) is the highest pressure measured during inspiration will be used.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
4 weeks
Results posted on
2026-01-21
Participant Flow
56 patients with CVD were screened. 32 declined to participate and 13 did not meet the inclusion criteria.
Participant milestones
| Measure |
Study Group
Patients who will perform inspiratory muscle training (IMT) with %60 of MIP intensity
|
Sham Group
Patients who will perform Sham-IMT
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
6
|
|
Overall Study
COMPLETED
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Study Group
n=5 Participants
Patients who will perform inspiratory muscle training (IMT) with %60 of MIP intensity
|
Sham Group
n=6 Participants
Patients who will perform Sham-IMT
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.8 Years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
60.5 Years
STANDARD_DEVIATION 7.1 • n=6 Participants
|
60.6 Years
STANDARD_DEVIATION 8.0 • n=11 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=6 Participants
|
5 Participants
n=11 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=6 Participants
|
6 Participants
n=11 Participants
|
|
Body mass index
|
36.1 kg/m^2
STANDARD_DEVIATION 16.5 • n=5 Participants
|
34.1 kg/m^2
STANDARD_DEVIATION 5.9 • n=6 Participants
|
35.0 kg/m^2
STANDARD_DEVIATION 11.3 • n=11 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 4 weeksmaximal inspiratory pressure (MIP) is the highest pressure measured during inspiration will be used.
Outcome measures
| Measure |
Sham Group
n=6 Participants
Patients who will perform Sham-IMT
|
Study Group
n=5 Participants
Patients who will perform inspiratory muscle training (IMT) with %60 of MIP intensity
|
|---|---|---|
|
Inspiratory Muscle Function
Baseline
|
52.8 cm H2O
Standard Deviation 12.5
|
46.4 cm H2O
Standard Deviation 13.4
|
|
Inspiratory Muscle Function
Post
|
50.0 cm H2O
Standard Deviation 15.8
|
68.8 cm H2O
Standard Deviation 13.6
|
PRIMARY outcome
Timeframe: 4 weeksflow-mediated dilation (FMD) ultrasound measurements of brachial artery flow-mediated dilatation will be performed.
Outcome measures
| Measure |
Sham Group
n=6 Participants
Patients who will perform Sham-IMT
|
Study Group
n=5 Participants
Patients who will perform inspiratory muscle training (IMT) with %60 of MIP intensity
|
|---|---|---|
|
Endothelial Function
Baseline
|
3.88 Percentage
Standard Deviation 2.26
|
5.41 Percentage
Standard Deviation 1.93
|
|
Endothelial Function
Post
|
3.00 Percentage
Standard Deviation 1.51
|
7.53 Percentage
Standard Deviation 1.62
|
PRIMARY outcome
Timeframe: 4 weeksarterial stiffness will be assessed by measuring pulse wave velocity.
Outcome measures
| Measure |
Sham Group
n=6 Participants
Patients who will perform Sham-IMT
|
Study Group
n=5 Participants
Patients who will perform inspiratory muscle training (IMT) with %60 of MIP intensity
|
|---|---|---|
|
Arterial Stiffness
Baseline
|
5.57 m per second
Standard Deviation 0.58
|
6.19 m per second
Standard Deviation 0.53
|
|
Arterial Stiffness
Post
|
5.58 m per second
Standard Deviation 0.56
|
6.11 m per second
Standard Deviation 0.56
|
SECONDARY outcome
Timeframe: 4 weeksmaximal distance in 6 minute walk test will be used.
Outcome measures
| Measure |
Sham Group
n=6 Participants
Patients who will perform Sham-IMT
|
Study Group
n=5 Participants
Patients who will perform inspiratory muscle training (IMT) with %60 of MIP intensity
|
|---|---|---|
|
Functional Exercise Capacity
Baseline
|
309.2 meters
Standard Deviation 33.5
|
301 meters
Standard Deviation 39.8
|
|
Functional Exercise Capacity
Post
|
305.0 meters
Standard Deviation 34.9
|
340.4 meters
Standard Deviation 36.6
|
SECONDARY outcome
Timeframe: 4 weeksThe modified Medical Research Council (mMRC) Dyspnea Scale, which have 5 points (0 to 4) will be used. High scores presented worsen dyspnea.
Outcome measures
| Measure |
Sham Group
n=6 Participants
Patients who will perform Sham-IMT
|
Study Group
n=5 Participants
Patients who will perform inspiratory muscle training (IMT) with %60 of MIP intensity
|
|---|---|---|
|
Dyspnea
Baseline
|
2.5 score
Standard Deviation 0.6
|
2.8 score
Standard Deviation 0.5
|
|
Dyspnea
Post
|
2.7 score
Standard Deviation 0.5
|
1.6 score
Standard Deviation 0.6
|
Adverse Events
Study Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham 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