Eccentric exercise program for older adults with heart failure and muscle loss

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Verona
  Verona, Verona, Italy Recruiting
• University of Verona
  Verona, Verona, Italy Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.