N/A
N=45
Exercise Therapy to Reduce Heart Failure Symptoms; Sorting Mechanisms of Benefit
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT03648762 ↗Enrolled (actual)
45
Serious AEs
46.0%
Results posted
Jun 2024
Primary outcome: Primary: Oxygen Uptake (VO2) Peak — 1778.1; 1228.2; 1393.7; 1763.6 ML/KG/Min
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Aerobic Exercise Intervention (Behavioral); Combined Aerobic and Strength Exercise Intervention (Behavioral); Inspiratory Muscle Training Exercise Intervention (Behavioral)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Oxygen Uptake (VO2) Peak |
1778.1; 1228.2; 1393.7; 1763.6; 1295.4; 1405.9 | — |
| PRIMARY One Repetition Maximum- Leg Press |
430.3; 348.2; 421.1; 433; 355.5; 409.5 | — |
| SECONDARY Metabolomics |
6.2; 7.7; 7.2; 5.6; 10.8; 6.6 | — |
| SECONDARY Skeletal Muscle Gene Expression |
0; 1; 1 | — |
| SECONDARY Quality of Life and Daily Function Questionnaires |
36; 37.7; 39.5; 40; 38; 43 | — |
| SECONDARY Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire for Older Adults - Frequency Component |
14.7; 13.6; 9.5; 23.5; 22.5; 19.5 | — |
| SECONDARY Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire for Older Adults - Duration Component |
15.2; 7.7; 5.7; 21.8; 14.3; 14.4 | — |
Summary
The purpose of this research study is to better understand how exercise training in older adults (≥65 years) with heart failure (HF) affects skeletal muscle both intrinsically and in respect to its impact on functional capacity. While many conceptualize HF as a pathophysiology that exclusively affects the heart, skeletal muscle atrophy and weakening are also elemental to the disease. While reduced exercise capacity is typically associated with HF, this may be related more to disease effects in skeletal muscle than the heart. This is a clinical study that focuses on exercise training which compares functional endpoints before and after training. Patients are randomized to one of three exercise training interventions (aerobic vs. aerobic and strength vs. inspiratory muscle training) for 12 weeks and are assessed pre- and post-training to determine if any differences occur in their skeletal muscle and functional capacity. Skeletal muscle biopsies before and after the exercise training intervention in order to study changes in skeletal muscle histology and biology.
Functional endpoints in this study include ventilatory gas indices from cardiopulmonary exercise testing, lower body strength testing, grip strength, sit-to-stand, six-minute-walk distance, gait speed, inspiratory muscle strength, and quality of life and physical activity-oriented questionnaires, including the Kansas City Cardiomyopathy Questionnaire, Duke Activity Status Index, and CHAMPS Physical Activity Questionnaire for Older Adults. Body composition is measured with Dual Energy X-ray (DXA) scanning. Skeletal muscle biopsies are completed in the vastus lateralis of the non-dominant leg to assess histology and biologic endpoints.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of Heart failure
- Echo in two years
- NYHA class II or III
- Optimal therapy according to AHA/ACC and HFSA HF guidelines; unless documented by a provider for variation.
Exclusion Criteria
- Major cardiovascular event or procedure within the prior 6 weeks.
- Dementia
- Severe COPD (FEV1<50%),
- End-stage malignancy
- Severe valvular heart disease that would make exercise un safe
- Orthopedic limitation preventing exercise
- Any bleeding disorder that would contraindicate safe exercise
- Women who are pregnant, breastfeeding, or likely to become pregnant within the next 6 months
- Psychiatric hospitalization within the last 3 months
- ICD device with heart rate limits that prohibit exercise assessments or exercise training.
- Referring physicians will be provided with an opportunity to reprogram devices so that patients can participate.
- Chronic use of oral corticosteroids or medications that affect muscle function.
- Notably, patients using statins will be eligible, and this will be factored into the randomization and analysis.
- Chronic ETOH or drug dependency shown within the last year
Data sourced from ClinicalTrials.gov (NCT03648762). 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.