Clinical trial
Feasibility and Effectiveness of Eccentric Exercise in Sarcopenic Older Adults with Heart Failure: a Pilot Study
Recruiting now · Not applicable · 1 countries · Registry ID NCT06826963
What this study is about
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…
Basic eligibility
Full registry criteria
Treatments and study arms
Aerobic eccentric intervention
This 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.
Primary outcomes
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%
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%
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%
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 \[%\])
Study locations
2 locations were listed when this page was built. The first 40 are shown.