Eccentric exercise program for older adults with heart failure and muscle loss
The Role of Eccentric Exercise in the Older Sarcopenic Population with Heart Failure: a Feasibility and Efficacy Study Protocol
This study is testing a 12-week exercise program for older adults with heart failure and muscle loss to see if it can help them get stronger and feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 65 Years to 85 Years |
| Sex | All |
| Sponsor | Universita di Verona Academic / other |
| Locations | 2 sites (Verona, Verona and 1 other locations) |
| Trial ID | NCT06826963 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the safety, feasibility, and effectiveness of a 12-week eccentric exercise program specifically designed for older adults suffering from sarcopenia or sarcopenic obesity alongside chronic heart failure. Participants will undergo a familiarization phase to adapt to the exercise equipment and intensity levels, ensuring safety and adherence. The study aims to monitor improvements in physical performance, muscle strength, and overall health while minimizing strain on the participants. By focusing on eccentric exercise, which has shown potential benefits for muscle function, the study seeks to determine its viability as a treatment option for this population.
Who should consider this trial
Good fit: Ideal candidates are older adults aged 65 to 85 years diagnosed with stable heart failure and classified as having sarcopenia or sarcopenic obesity.
Not a fit: Patients who are younger than 65 or do not meet the criteria for heart failure or sarcopenia may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve physical performance and quality of life for older adults with heart failure and muscle loss.
How similar studies have performed: While eccentric exercise has shown promise in other contexts, this specific application in older adults with heart failure and sarcopenia is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Participants must meet all of the following criteria: * Age 65 to 85 years * Diagnosed with stable heart failure (HF), defined as: * Preserved left ventricular ejection fraction (≥50%) or * Reduced ejection fraction (≤40%) * Classified as New York Heart Association (NYHA) class 1, 2, or 3 * Meet the diagnostic criteria for sarcopenia or sarcopenic obesity: * Sarcopenia: Impaired muscle strength with the Five-repetition chair stand test time \>15 seconds (normal weight) or \>17 seconds (patients with obesity) * Reduced muscle mass according to the European Working Group on Sarcopenia (EWGSOP) or Sarcopenic Obesity: Based on the European Society for Clinical Nutrition and Metabolism (ESPEN) and the European Association for the Study of Obesity (EASO). * For EWGSOP: Sarcopenia as Class I: Skeletal muscle mass index (kg/m²) * Males: ≤10.75 kg/m² * Females: ≤6.75 kg/m² * For EWGSOP: Sarcopenia as Class II: Skeletal muscle mass index (kg/m²) * Males: ≤8.50 kg/m² * Females: ≤5.75 kg/m² * For ESPEN-EASO: Obesity: waist circumference calculated in centimeters (cm) * Males: ≥102 cm * Females: ≥ 88 cm Sarcopenia as Class I: Skeletal muscle index as a percentage of body weight (%) * Males: 31.3-37% * Females: 22.1-27.6% Sarcopenia as Class II: * Males: \<31.5% * Females: \<22.1% Exclusion Criteria: Participants will be excluded if they meet any of the following conditions: * Severe obstructive heart disease * Aortic valve stenosis * Severe arrhythmias identified during initial stress testing * Intracavitary thrombosis * Severe pulmonary hypertension (\>70 mmHg) * History of venous thromboembolism within the previous three months * History of heart transplantation * Medical conditions that significantly limit functional capacity beyond the impact of HF
Where this trial is running
Verona, Verona and 1 other locations
- University of Verona — Verona, Verona, Italy (Recruiting)
- University of Verona — Verona, Verona, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.