Feasibility and Effectiveness of Eccentric Exercise in Sarcopenic Older Adults with Heart Failure: a Pilot Study

NCT06826963 | Recruiting

• 2 other identifiers: Prot. n. 45282 date 13/08/2024CUP B43C22000450006
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

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. 1.Short Physical Performance Battery (SPPB): Evaluates mobility and strength.
2. 2.6-Minute Walk Test (6MWT): Measures cardiovascular fitness.
3. 3.Handgrip Strength and Leg Strength Tests: Assess upper and lower body muscle strength.
4. 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.
5. 5.Recruitment and Completion Rate: The ratio of participants recruited to those who successfully complete the study, including post-intervention assessments.
6. 6.Session Attendance: The number of training sessions attended out of the total planned sessions.
7. 7.Adherence to Training Volume: The number of prescribed exercises completed by participants compared to the total planned.
8. 8.Program Tolerance: Evaluated by comparing the Rate of Perceived Exertion (RPE) during sessions to the target RPE.
9. 9.SARC-F: A tool for identifying individuals at risk of sarcopenia, based on self-reported issues like weakness and difficulty walking.
10. 10.Mini Nutritional Assessment (MNA): Evaluates nutritional status to rule out malnutrition, which could affect training outcomes.
11. 11.Mini Mental State Examination (MMSE): Assesses cognitive function.
12. 12.Minnesota Living with Heart Failure Questionnaire: Evaluates how heart failure affects daily life.
13. 13.International Physical Activity Questionnaire (IPAQ): Measures physical activity levels at baseline.

Conditions

Heart Failure with Preserved Ejection Fraction (HFPEF); Heart Failure with Reduced Ejection Fraction; Sarcopenia in Elderly; Sarcopenic Obesity

Keywords

eccentric exercise; older adults; heart failure; sarcopenia; sarcopenic obesity; muscle strength; muscle mass; exercise intervention; aging

Outcome Measures

Primary Outcomes (4)

• 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%

  Recruitment and retention will be assessed at baseline and week 12.

• 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%

  Session attendance will be monitored weekly, with a final assessment at week 12.

• 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%

  Adherence, will be monitored weekly, with a final assessment at week 12.

• 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 \[%\])

  Program tolerance will be monitored weekly, with a final assessment at week 12.

Secondary Outcomes (20)

• SARC-F questionnaire

  Pre and after 12 weeks

• MNA questionnaire

  Pre and after 12 weeks

• MMSE questionnaire

  Only at PRE test

• Minnesota Living with HF Questionnaire

  Pre and after 12 weeks

• Physical Activity Level (IPAQ)

  Only at PRE.

Study Arms (1)

Older adults with sarcopenia and heart failure

EXPERIMENTAL

Men and women aged 65 to 85 years, with stable heart failure (HF) (either preserved left ventricular ejection fraction (≥50%) or reduced ejection fraction (≤40%)). Eligibility requires classification as New York Heart Association (NYHA) class 1, 2, or 3, and meeting the diagnostic criteria for sarcopenia or sarcopenic obesity. Sarcopenic patients are classified by skeletal muscle mass index (kg/m²): class I (males ≤10.75, females ≤6.75) and class II (males ≤8.50, females ≤5.75). For sarcopenic obesity, the classifications are: class I (males 31.3-37%, females 22.1-27.6%) and class II (males \<31.5%, females \<22.1%). 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.

Other: Aerobic eccentric intervention

Interventions

Aerobic eccentric intervention OTHER

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.

Older adults with sarcopenia and heart failure

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (2)

University of Verona

Verona, Verona, 37131, Italy

RECRUITING

University of Verona

Verona, Verona, 37131, Italy

RECRUITING

MeSH Terms

Conditions

Heart Failure; Sarcopenia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: February 14, 2025
• Study Start: October 15, 2024
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: March 14, 2025

Record last verified: 2024-12

Locations

IT (2)