This study is designed to evaluate the safety, feasibility, and effectiveness of a 12-week eccentric exercise program for older adults with sarcopenia (muscle loss) or sarcopenic obesity and chronic heart failure (HF). The program aims to improve physical performance, muscle strength, and overall health without causing excessive strain on participants. Eccentric exercise has shown potential benefits for improving muscle function, and this study will help determine if it is a safe and effective option for individuals with heart failure and muscle loss.
Study Goals: The primary aim of this study is to test the feasibility and effectiveness of an eccentric exercise program for older adults with sarcopenia and CHF. The study will monitor physical performance, adherence to the program, and participants' ability to tolerate the exercise, as well as any impact on heart and muscle health.
Study Population: A screening visit will be scheduled to determine if individuals meet the criteria to participate in the study. During this visit, a detailed assessment will be made, and if eligible, participants will sign an informed consent form.
This study will assess whether a 12-week eccentric exercise program can help improve muscle strength, cardiovascular health, and overall physical performance in individuals with HF and sarcopenia. The program will involve exercising on an eccentric bike, which is designed to reduce strain on the heart while providing effective muscle strengthening benefits.
The study will use several physical performance tests to assess the impact of the exercise program, including:
1. Short Physical Performance Battery (SPPB): Evaluates mobility and strength. 2. 6-Minute Walk Test (6MWT): Measures cardiovascular fitness. 3. Handgrip Strength and Leg Strength Tests: Assess upper and lower body muscle strength. 4. Additionally, body composition will be evaluated using tools such as DXA scans and bioelectrical impedance analysis (BIA) to measure muscle mass, fat, and overall health status. The program's adherence and tolerance will be carefully monitored by measuring session completion, intensity, and participant feedback.
Primary Outcomes
Feasibility Measures:
1. Recruitment and Completion Rate: The ratio of participants recruited to those who successfully complete the study, including post-intervention assessments. 2. Session Attendance: The number of training sessions attended out of the total planned sessions. 3. Adherence to Training Volume: The number of prescribed exercises completed by participants compared to the total planned. 4. Program Tolerance: Evaluated by comparing the Rate of Perceived Exertion (RPE) during sessions to the target RPE.
To be considered feasible, the study must meet these criteria: Recruitment \>50%, Follow-up loss \<20%, Median attendance at training sessions \>80%, Median adherence to prescribed volume \>75%, Tolerance to RPE \>70%.
Secondary Outcomes
Effectiveness Measures:
1. SARC-F: A tool for identifying individuals at risk of sarcopenia, based on self-reported issues like weakness and difficulty walking. 2. Mini Nutritional Assessment (MNA): Evaluates nutritional status to rule out malnutrition, which could affect training outcomes. 3. Mini Mental State Examination (MMSE): Assesses cognitive function. 4. Minnesota Living with Heart Failure Questionnaire: Evaluates how heart failure affects daily life. 5. International Physical Activity Questionnaire (IPAQ): Measures physical activity levels at baseline.
In addition to the physical performance tests mentioned, the study will assess muscle mass and fat distribution using DXA scans and BIA, providing a comprehensive view of body composition. Finally, the feasibility of remotely monitoring patients' physical activity to determine the impact of the intervention on their daily lives, specifically in terms of mobility and autonomy is assessed. To this end, patients will be asked to wear a set of five sensors (two on the ankles, two on the wrists, and one on the waist) for at least four days. The Axivity AX6 sensors, chosen for their light weight and long battery life, will collect data used to monitor time spent moving, sitting, and lying down, as well as to assess the quality of the recorded movements.
Age 65 to 85 years
Preserved left ventricular ejection fraction (≥50%) or
Reduced ejection fraction (≤40%)
Classified as New York Heart Association (NYHA) class 1, 2, or 3
Severe obstructive heart disease
Aortic valve stenosis
Severe arrhythmias identified during initial stress testing
Intracavitary thrombosis
Single group
Aerobic eccentric intervention
Other interventionThis arm will participate in a supervised eccentric cycling training program for three months. The intervention will include two training sessions per week in the first month, increasing to three sessions per week in the following two months. Each session will consist of a warm-up (5 minutes), a main training phase (20-30 minutes), and a cool-down (5-10 minutes). The intensity of training will be gradually adjusted to maintain a perceived exertion rating (RPE) between light and moderate with a target heart rate zone (57-76% of HRmax). Pre- and post-training assessments will evaluate physical function through several tests, body composition and anthropometric indices, muscle strength of upper and lower limbs, questionnaires related to the overall health improvement. Finally, participants will also be monitored for daily physical activity through wearable sensors to track mobility and autonomy.
Recruitment and Retention Rate
The feasibility of implementing a three-month eccentric cycling training program will be assessed using the following individual measures: Recruitment and Retention Rate: % of enrolled participants who complete post-intervention assessments. (Units of measures: Percentage \[%\]) Criteria for Feasibility: • Recruitment\>50%
Session Attendance
The feasibility of implementing a three-month eccentric cycling training program will be assessed using the following individual measure: Session Attendance - Median number of training sessions attended relative to the total planned sessions. (Units of measures: Percentage \[%\]) Median session attendance\>80%
Adherence to Training Volume
The feasibility of implementing a three-month eccentric cycling training program will be assessed using the following individual measures: Adherence to Training Volume - Median percentage of prescribed exercises completed relative to the total planned. (Units of measures: Percentage \[%\]) Criteria for Feasibility: • Median session attendance\>80%
Program Tolerance
The feasibility of implementing a three-month eccentric cycling training program will be assessed using the following individual measure: Program Tolerance - Proportion of participants achieving the target Rate of Perceived Exertion (RPE) during sessions. (Units of measures: Percentage \[%\])
SARC-F questionnaire
score 0-10; The SARC-F questionnaire is a simple and widely used screening tool for sarcopenia, a condition characterized by the loss of muscle mass, strength, and function, often associated with aging and certain diseases.
MNA questionnaire
The Mini Nutritional Assessment (MNA) is a validated screening tool designed to assess the nutritional status of older adults (aged 65 and above) and identify those at risk of malnutrition. (score 0-30)
MMSE questionnaire
The Mini-Mental State Examination (MMSE) is a widely used cognitive screening tool designed to assess an individual's mental status and detect cognitive impairment, such as in dementia or mild cognitive impairment (MCI). (score 0-30).
Minnesota Living with HF Questionnaire
The Minnesota Living with Heart Failure Questionnaire (MLHFQ) is a validated patient-reported outcome measure designed to assess the impact of heart failure (HF) on an individual's quality of life (QoL). It is widely used in clinical practice and research to evaluate the severity of symptoms, functional limitations, and emotional well-being in patients with heart failure (score 0-105).
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