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Eccentric Muscle Training in Cardiac Rehabilitation

2026년 6월 3일 업데이트: University Hospital, Antwerp

Eccentric Muscle Training in Cardiac Rehabilitation: Randomized Controlled Trial to Evaluate Effectiveness and Feasibility in Heart Failure Patients With Reduced Ejection Fraction

The goal of this interventional study is to assess the training effects in a training schedule in which eccentric overload training and eccentric cycle training are used.

Researchers will compare a training program of eccentric overload training and eccentric cycling training with a traditional training program of strength and cardio training in people with heart failure with reduced ejection fraction.

This study will be delivered in a cardiac rehabilitation setting.

연구 개요

상세 설명

Patients with HFrEF experience in general more difficulties completing exercise training trajectory because of low physical fitness and multiple comorbidies.

In this study traditional exercise capacity outcomes are assessed eg. endurance capacity, muscle strength and muscle mass in patients with HFrEF.

It is hypothesized that greater muscle strength and muscle mass are obtained by eccentric muscle training in comparison with conventional training because higher training volumes can be used with a lower metabolic demand.

Possibly, a better outcome regarding muscle function and mass will influence VO2 peak and functionality in this patient population.

연구 유형

중재적

등록 (추정된)

3

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Wendy Hens, PhD
  • 전화번호: 0032 3 275 73 89
  • 이메일: wendy.hens@uza.be

연구 장소

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • HFrEF patients with ejection fraction <40%
  • Exercise intolerance (<85% of predicted VO2 peak)
  • clinically stable for > 6 weeks, optimal medical treatment for > 6 weeks

Exclusion Criteria:

  • Contra indications for cardiac exercise rehabilitation as per consensus guidelines and recommendations
  • Musculoskeletal disorders that hamper (progression in) strength training
  • Non-stabilized acute coronary syndrome
  • Current acute heart failure (decompensation)
  • Patient having sustained a recent (<3 months) procedure that could act as a confounder to increase VO2peak (i.e., coronary artery bypass graft surgery, percutaneous coronary intervention, cardiac resynchronization therapy, valve surgery or reparation)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Eccentric strength training + cardio
45 sessions experimental protocol
progressive following protocol, 10min
dynamic strength training + eccentric overload, progressive over time, 3sets*10reps (15-20min)
aerobic training, progressive over time, 10 min
활성 비교기: Traditional strength training + cardio
45 sessions traditional cardiac rehabilitation
aerobic training, progressive over time, 10 min
aerobic training, progressive following protocol, 10 min
dynamic strength training, progression over time, 15-20 min

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
1Repetition Maximum (=RM) leg press (kg)
기간: pre (baseline) + post (15 weeks)

One repetition maximum on leg press device Technogym BioCircuit. The patient is positioned correctly on the leg press (back supported, feet on platform in standardized way so that repeated tests are in the same position).

The patiënt performes a maximal push, the load is automatically adjusted by the BioCircuit algorithm.

The system identifies the maximum successful single push as the 1RM (kg).

pre (baseline) + post (15 weeks)
1Repetition Maximum (=RM) Low Row (kg)
기간: pre (baseline) + post (15weeks)

One repetition maximum on the low row device Technogym BioCircuit. The patient sits with chest supported, feet on the ground, and grips the handles with arms extended.

The patiënt performes a maximal pull, the load is automatically adjusted by the BioCircuit algorithm. The system identifies the maximum successful single lift as the 1RM (kg).

pre (baseline) + post (15weeks)
1Repetition Maximum (=RM) chest press (kg)
기간: pre (baseline) + post (15weeks)
One repetition maximum on chest press device Technogym BioCircuit. The patient is positioned correctly on the chest press (back supported, feet on the ground in standardized way so that repeated tests are in the same position). The patiënt performes a maximal push, the load is automatically adjusted by the BioCircuit algorithm. The system identifies the maximum successful single push as the 1RM (kg).
pre (baseline) + post (15weeks)
1Repetition Maximum (=RM) vertical traction (kg)
기간: pre (baseline) + post (15weeks)

One repetition maximum on vertical traction device Technogym BioCircuit. The patient is positioned correctly on the vertical traction (back supported, feet on the ground in standardized way so that repeated tests are in the same position).

The patiënt performes a maximal pull, the load is automatically adjusted by the BioCircuit algorithm.

The system identifies the maximum successful single push as the 1RM (kg).

pre (baseline) + post (15weeks)
Handgrip strength
기간: pre (baseline) + post (15 weeks)

The Jamar handgrip dynamometer is used to measure grip strength in a standardized way ( 90° flex elbow, forearm neutral, and wrist slightly extended).

3 trials per hand are performed, with 10seconds rest in between. The average value is recorded as grip strength.

pre (baseline) + post (15 weeks)
Isometric Qceps peak torque (Nm)
기간: pre (baseline) + post (15weeks)

The subject is seated in the Biodex System dynamometer and securely strapped (trunk, pelvis, thigh). The dynamometer axis is aligned with the knee joint axis (lateral femoral epicondyle).

The knee is fixed at 60° of flexion (0° = full extension). The lower leg is attached to the lever arm just above the ankle. The subject performs a maximal isometric knee extension (pushing against the immovable arm) for 3seconds.

3 tests are done with 10seconds rest in between. The highest torque value (Nm) recorded is taken as the quadriceps peak torque.

pre (baseline) + post (15weeks)

2차 결과 측정

결과 측정
측정값 설명
기간
6mwt (m)
기간: pre (baseline) - post (15weeks)

The 6-minute walk test (6MWT) assesses functional exercise capacity by measuring the distance walked in 6 minutes.

It is performed on the same flat, straight corridor (50 meter) with marked turnaround points.

The participant is instructed to walk as fast as possible at a self-paced speed.

Standardized encouragement is given every minute. A timer is started at the beginning and stopped at 6 minutes. The total distance walked is measured in meters.

pre (baseline) - post (15weeks)
Time up and go (s)
기간: pre (baseline) + post (15weeks)

The participant starts seated in a standard chair (back against the chair, no armrests) On the command "go," the participant stands up, walks 3 meters, turns around, walks back, and sits down again.

Timing starts on "go" and stops when the participant is seated again with the back against the chair). The test is performed 3 times (with 20seconds rest in between).

The outcome is the mean time taken to complete the 3 tasks (seconds).

pre (baseline) + post (15weeks)
VO2 peak (ml/kg/min)
기간: pre (baseline) + post (15weeks)

VO₂peak is measured during a cardiopulmonary exercise test (CPET) on a cycle ergometer. The test is performed on a Lode Corival ergometer with breath-by-breath gas analysis via a Vyaire Medical system.

After calibration of flow and gas analyzers, the subject is fitted with a mask and monitoring devices (ECG, BP). A short resting phase and unloaded cycling (warm-up) are performed. Workload then increases continuously using an individualized ramp protocol (e.g. 5-20 Watt/min - so small increase every 3-12 seconds). The same protocol is used in the pre and post test.

The participant cycles at a constant cadence(≈60-70 revolutions/min) until volitional exhaustion. Expired gases are analyzed to determine oxygen uptake (VO₂) and carbon dioxide production (VCO₂). Strong verbal encouragement is given to reach maximal effort. VO₂peak is defined as the mean VO₂ value averaged over the final 30 seconds of exercise.

Test termination follows symptom limitation or standard clinical safety criteria.

pre (baseline) + post (15weeks)
maximal load (Watt)
기간: pre (baseline) + post (15weeks)

Wattmax is determined during a CPET performed on a Lode Corival ergometer with monitoring via a Vyaire Medical system.

After calibration of flow and gas analyzers, the subject is fitted with a mask and monitoring devices (ECG, BP). A short resting phase and unloaded cycling (warm-up) are performed. Workload then increases continuously using an individualized ramp protocol (e.g. 5-20 Watt/min - so small increase every 3-12 seconds). The same protocol is used in the pre and post test. The participant cycles at a constant cadence (≈60-70 revolutions/min) until volitional exhaustion.

Wattmax is defined as the highest workload (in watts) achieved in the final stage.

Strong encouragement is provided to achieve maximal effort.

pre (baseline) + post (15weeks)
VO2/W slope (ml/min/W)
기간: pre (baseline) + post (15weeks)

VO2/W slope is measured during a cardiopulmonary exercise test (CPET) on a cycle ergometer. The test is performed on a Lode Corival ergometer with breath-by-breath gas analysis via a Vyaire Medical system. After calibration of flow and gas analyzers, the subject is fitted with a mask and monitoring devices (ECG, BP). A short resting phase and unloaded cycling (warm-up) are performed. Workload then increases continuously using an individualized ramp protocol (e.g. 5-20 Watt/min - so small increase every 3-12 seconds). The same protocol is used in the pre and post test. The participant cycles at a constant cadence (≈60-70 revolutions/min) until volitional exhaustion.

The relationship between VO₂ (y-axis) and work rate (x-axis) is plotted. A linear regression is applied. The slope of this line represents the VO₂/W slope (mL/min/W).

pre (baseline) + post (15weeks)
VE/VCO2 slope
기간: pre (baseline) + post (15weeks)

The VE/VCO₂ slope is measured during CPET on a Lode Corival ergometer with breath-by-breath analysis via Vyaire Medical.

After calibration of flow and gas analyzers, the subject is fitted with a mask and monitoring devices (ECG, BP). A short resting phase and unloaded cycling (warm-up) are performed. Workload then increases continuously using an individualized ramp protocol (e.g. 5-20 Watt/min - so small increase every 3-12 seconds). The same protocol is used in the pre and post test. The participant cycles at a constant cadence (≈60-70 revolutions/min) until volitional exhaustion.

VE is plotted against VCO₂ over the course of exercise. A linear regression is applied from the start of exercise up to the ventilatory compensation point.

The slope of this relationship represents the VE/VCO₂ slope.

pre (baseline) + post (15weeks)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2023년 1월 20일

기본 완료 (추정된)

2026년 9월 30일

연구 완료 (추정된)

2027년 1월 1일

연구 등록 날짜

최초 제출

2025년 12월 1일

QC 기준을 충족하는 최초 제출

2026년 6월 3일

처음 게시됨 (실제)

2026년 6월 9일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 9일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 3일

마지막으로 확인됨

2026년 4월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • EDGE 002632
  • Belgian Heart Fund (기타 보조금/기금 번호: King Baudouin Foundation)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

depending on collaboration - if in line with privacy policy this might be done

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다