N/A
Completed N=16
Effects of a Walking Program and Inspiratory Muscle Training in Individuals With Chronic Heart Failure
Heart Failure NYHA Class II · Heart Failure NYHA Class III
Source: ClinicalTrials.gov NCT01560871 ↗
Enrolled (actual)
16
Serious AEs
18.8%
Results posted
Apr 2020
Primary outcomePrimary: Change From Baseline in Mean Minnesota Living With Heart Failure Questionnaire Score — 36; 57.6; 18.6; -20.6 score on a scale
Summary
Individuals with chronic heart failure need a "safe and effective" exercise program that could enhance their quality of life. In this study, we examined whether an experimental exercise program of autonomous walking and high-intensity Inspiratory Muscle Training (IMT) could result in better effects on respiratory muscle strength (PImax), cardiovascular endurance, quality of life, and physical activity, when compared to autonomous walking and "sham" IMT program, in adults with chronic heart failure.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Minnesota Living With Heart Failure Questionnaire Score |
36; 57.6; 18.6; -20.6 | — |
| PRIMARY Change From Baseline in Mean Score of Physical Component of the SF-36 Questionnaire |
34.1; 30.7; 0.82; 7.08 | — |
| SECONDARY Mean Daily Step Counts From Week 1 to Week 6 |
3512; 7002; 4434; 9255 | — |
| SECONDARY Respiratory Muscle Strength is Indicated by Maximal Inspiratory Pressure (PImax) |
51.44; 43.53; 57.22; 58.13 | — |
| SECONDARY Six-minute Walk Test Distance |
356.16; 378.04; 375.78; 419.71 | — |
Eligibility Criteria
Inclusion Criteria
- adults with chronic heart failure (NYHA Functional Class II-III)
- BMI < 35 kg/m^2
- Age: 18 to 90 years
- walk independently with or without an assisted device
- hospital discharge for CHF within a year.
Exclusion Criteria
- ECG with uncontrolled ventricular arrhythmia
- bronchiectasis
- limited walking ability due to neurologic or orthopedic impairments of the legs
Data sourced from ClinicalTrials.gov (NCT01560871). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.