Clinical trial NCT06826963: Feasibility and Effectiveness of Eccentric Exercise in Sarcopenic Older Adults with Heart Failure: a Pilot Study
Official title: The Role of Eccentric Exercise in the Older Sarcopenic Population with Heart Failure: a Feasibility and Efficacy Study Protocol
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 15
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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. 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.

Detailed description: Training protocol overview Familiarization Phase Before starting the actual training program, patients will undergo a familiarization phase to allow them to adjust to the eccentric cycling equipment and understand the intensity of the exercises. This phase is critical for ensuring safety and optimizing adherence to the program.

Duration of Familiarization:

The familiarization phase will last for two weeks. The first week (sessions 4 and 5, conducted within the same week after medical screening and body composition testing) will focus on achieving an intensity that is perceived as "very light" (RPE 8-9) and maintaining it for 5-10 minutes.

The second week will aim for a light (RPE 10-11) to slightly heavy (RPE 10-13) intensity.

Muscle Pain Monitoring:

At the beginning and end of each familiarization session, patients will be asked to rate their muscle pain using the Visual Analog Scale (VAS) (0-10), where 0 represents no pain and 10 indicates unbearable pain. This ensures that any discomfort is monitored and managed appropriately, reducing the risk of muscle injury and enhancing adherence to the program.

Purpose of Familiarization:

This phase helps patients adapt to eccentric training, preventing unnecessary muscle damage and ensuring they are comfortable with the equipment and the level of exertion. It also serves to acclimatize the patients to the specific eccentric muscle contractions involved in the cycling exercise.

Exercise Prescription Trained kinesiologists will supervise the eccentric cycling sessions. Monitoring and adjusting exercise intensity based on heart rate (HR) and Rate of Perceived Exertion (RPE) will be central to ensuring safety and effectiveness throughout the intervention.

Intensity Monitoring: For participants on beta-blockers, maximum heart rate (HRmax) will be estimated using the formula: HRmax = 164 - (0.7 × age). For participants not on beta-blockers, HRmax will be calculated using: HRmax = 211 - (0.64 × age).

The HR and RPE will be continuously monitored to ensure participants are training within the prescribed intensity zones.

Target Intensity: The training intensity will be kept between light (57-64% of HRmax) and moderate/slightly heavy (64-76% of HRmax) levels. These ranges correspond to RPE values of approximately 10-14.

The intensity will vary within the session, with three different workloads: Light: RPE \~10, Moderate: RPE \~12, Slightly Heavy: RPE \~14

Session Structure: Each training session will be divided into three parts:

1. Warm-Up (5 minutes): Low-intensity cycling to prepare the body.
2. Main Training (20-30 minutes): The main part of the session will focus on eccentric cycling at varying intensities. The patients will alternate between light, moderate, and slightly heavy intensities, maintaining the prescribed intensity range (RPE \~10-14).
3. Cool-Down (5-10 minutes): Gradual reduction in intensity to aid in recovery. Progressive Training Plan: Week 1-4 (Adaptation Phase): Patients will train twice a week, with an emphasis on familiarizing themselves with the bike and adjusting to the intensity ranges.

The duration of the central training phase will start at 20 minutes. Week 5-8 (Strengthening Phase): Training frequency will increase to three times per week. The duration of the central phase will increase progressively to 30 minutes. The intensity will gradually rise within the prescribed target range, increasing as the patients adapt.

Week 9-12 (Maximal Tolerable Load Phase): The frequency remains three times a week. The intensity will reach the higher end of the prescribed range, with patients performing the eccentric cycling at near-maximal intensities (RPE 14-15). Adjustments Every Two Weeks: Every two weeks, the workload will be reassessed and adjusted to ensure the target RPE is achieved and maintained. This will ensure continued progression and avoid plateauing.

Pedaling Frequency: Participants will be instructed to maintain a pedal cadence of 60 RPM (revolutions per minute) for each session. This will be a consistent cadence for the entire training phase.

Eligibility 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

Primary outcomes:
measure: Recruitment and Retention Rate
timeFrame: Recruitment and retention will be assessed at baseline and week 12.
measure: Session Attendance
timeFrame: Session attendance will be monitored weekly, with a final assessment at week 12.
measure: Adherence to Training Volume
timeFrame: Adherence, will be monitored weekly, with a final assessment at week 12.
measure: Program Tolerance
timeFrame: Program tolerance will be monitored weekly, with a final assessment at week 12.
Secondary outcomes:
measure: SARC-F questionnaire
timeFrame: Pre and after 12 weeks
measure: MNA questionnaire
timeFrame: Pre and after 12 weeks
measure: MMSE questionnaire
timeFrame: Only at PRE test
measure: Minnesota Living with HF Questionnaire
timeFrame: Pre and after 12 weeks
measure: Physical Activity Level (IPAQ)
timeFrame: Only at PRE.
measure: Weight
timeFrame: Pre and after 12 weeks
measure: Height
timeFrame: Only at PRE.
measure: Body Mass Index
timeFrame: Pre and after 12 weeks
measure: Waist circumference
timeFrame: Pre and after 12 weeks
measure: Hip circumference
timeFrame: Pre and after 12 weeks
measure: Calf circumference
timeFrame: Pre and after 12 weeks
measure: Muscle mass
timeFrame: Pre and after 12 weeks
measure: Fat Mass
timeFrame: Pre and after 12 weeks
measure: Bone Density
timeFrame: Pre and after 12 weeks
measure: Short Physical Performance Battery
timeFrame: Pre and after 12 weeks
measure: Six Minute Walking Test
timeFrame: Pre and after 12 weeks
measure: Ten Meter Walking Speed
timeFrame: Pre and after 12 weeks
measure: HandGrip
timeFrame: Pre and after 12 weeks
measure: Isometric Force
timeFrame: Pre and after 12 weeks
measure: Isokinetic Force
timeFrame: Pre and after 12 weeks
Other outcomes:
Locations:
city: Verona
country: Italy
facility: University of Verona
city: Verona
country: Italy
facility: University of Verona
Study officials:
References: