- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07645040
Combined Arm-leg Ergometer Endurance Training Versus Cycle Ergometer Endurance Training in Myocardial Infarction
Effects of Combined Arm-leg Ergometer Endurance Training Versus Cycle Ergometer Endurance Training on Cardiorespiratory Fitness, Exercise Tolerance and Quality of Life in Patients With Post-myocardial Infarction
연구 개요
상태
정황
상세 설명
Myocardial infarction (MI) remains a primary contributor to long-term disability and cardiovascular death. After MI, patients typically experience reduced cardiorespiratory fitness, poor exercise tolerance, and diminished quality of life (QOL). Conventional rehabilitation using cycle ergometer training is well-established in improving VO₂ peak and functional capacity, yet it often neglects upper-limb reconditioning, which plays a crucial role in performing everyday tasks. Emerging evidence suggests that combining arm and leg ergometer endurance training offers a more comprehensive rehabilitation strategy by engaging a greater muscle mass, enhancing systemic oxygen delivery, and improving both upper- and lower-limb functionality. While upper-limb ergometry has demonstrated physiological benefits in COPD, coronary artery disease, and heart failure populations, it remains underutilized in post-MI rehabilitation protocols. The aim of the study is to compare the effects of combined arm leg ergometer endurance training versus cycle ergometer endurance training on cardiorespiratory fitness, exercise tolerance, and quality of life in patients with post-myocardial infarction. This study will be a randomized clinical trial. A non-probability convenience sampling method will be used. The study will be conducted at the Cardiac Rehab Unit, Cardiac Centers, and Hospitals, Pakistan. Patients will be selected according to the inclusion and exclusion criteria.
Data will be collected by three primary outcomes: cardiorespiratory fitness (measured by VO₂ peak), exercise tolerance (6-minute walk test), and quality of life (MacNew HRQOL questionnaire). A total of 40 medically stable post-MI patients will be recruited and randomized into two groups. Group A will participate in Combined Arm-Leg Ergometer Training, while Group B will receive Cycle Ergometer Training. Each session will last 30 minutes with a warm-up and cool-down period, which will be held 3 times per week for 6 weeks. Outcome measures will be taken at baseline and week 6. Data analysis will be done bySPSS version 25.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Muhammad Iqbal Tariq Tariq, Phd*
- 전화번호: 333826752
- 이메일: iqbal.tariq@riphah.edu.pk
연구 연락처 백업
- 이름: Nimra noor Noor, MS-CPPT
- 전화번호: 03030684869
- 이메일: nimranoor358@gmail.com
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Males and Females
- Patients with a history of myocardial infarction (MI)
- Medically stable for at least 1 month post-MI
- Age between 40-70 years.
- Willingness and ability to participate in exercise training.
- Medically cleared for exercise by a cardiologist.
Exclusion Criteria:
- Unstable angina or uncontrolled hypertension.
- Orthopedic/neurological limitations affecting participants.
- Arrhythmias
- Fever
- Cognitive impairment or non-consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: arm-leg ergometer ergometer
Group A, undergoing combined arm-leg ergometer training, will participate in exercise sessions three times per week for six weeks.
Each session will last between 30 minutes and will include a warm-up and cool-down period.
The intensity of the training will be maintained at a moderate level, corresponding to 50-70% of the individuals heart rate reserve or a score of 11-14 on the Borg Rating of Perceived Exertion (RPE) scale, which reflects "light to somewhat hard" exertion.
This protocol involves the simultaneous use of both upper and lower limbs, which may elicit a higher cardiovascular demand and greater systemic oxygen consumption
|
Each session will last between 30 minutes and will include a warm-up and cool-down period.
The intensity of the training will be maintained at a moderate level, corresponding to 50-70% of the individuals heart rate reserve or a score of 11-14 on the Borg Rating of Perceived Exertion (RPE) scale, which reflects "light to somewhat hard" exertion.
This protocol involves the simultaneous use of both upper and lower limbs, which may elicit a higher cardiovascular demand and greater systemic oxygen consumption, thereby potentially enhancing improvements in VO₂ peak and overall cardiovascular efficiency
|
|
실험적: traditional cycle ergometer
traditional cycle ergometer training, will follow the same frequency, intensity, and duration of training as Group A, but the type of exercise will be limited to lower limb cycling on a standard stationary bike.
This mode of training targets aerobic endurance primarily through leg muscles, which is the conventional method used in postmyocardial infarction rehabilitation exercise sessions three times per week for 6 weeks
|
same frequency, intensity, and duration of training as Group A, but the type of exercise will be limited to lower limb cycling on a standard stationary bike.
This mode of training targets aerobic endurance primarily through leg muscles, which is the conventional method used in postmyocardial infarction rehabilitation
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
cardiorespiratory fitness
기간: Baseline and after 6 weeks of intervention
|
measured by VO₂ peak.
VO₂ peak is an objective measure of cardiorespiratory fitness, indicating the maximum amount of oxygen the body can utilize during intense exercise.
It is typically recorded using a metabolic cart or estimated through submaximal or maximal exercise tests (e.g., using a cycle ergometer or treadmill).
The higher the VO₂ peak, the more efficient the cardiovascular and respiratory systems are at transporting oxygen to working muscles
|
Baseline and after 6 weeks of intervention
|
|
exercise tolerance
기간: Baseline and after 6 weeks of intervention
|
6-minute walk test.
The 6MWT is a widely used functional exercise test to assess submaximal aerobic capacity and endurance.
It measures the total distance an individual can walk on a flat surface in 6 minutes.
The test is practical, cost-effective, and well-tolerated by cardiac patients.
It reflects daily physical functioning and correlates with VO₂ peak in cardiac rehabilitation populations
|
Baseline and after 6 weeks of intervention
|
|
individual quality of life
기간: Baseline and after 6 weeks of intervention
|
MacNew HRQOL questionnaire.
The MacNew HRQOL questionnaire is a disease-specific, self-reported tool that assesses the emotional, physical, and social functioning of individuals with heart disease.
It contains 27 items divided into 3 domains and is scored on a 7-point Likert scale.
Higher scores indicate better perceived quality of life.
It is validated for post-MI and cardiac rehabilitation populations.
|
Baseline and after 6 weeks of intervention
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Nimra Noor, MS-CPPT, Riphah International University Lahore(Gulberg)
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
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