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Not yet recruiting NCT07645040

Combined Arm-leg Ergometer Endurance Training Versus Cycle Ergometer Endurance Training in Myocardial Infarction

No phase Interventional Post Myocardial Infarction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: arm-leg ergometer training, traditional cycle ergometer training.
Who it may be relevant to
Registry conditions: Post Myocardial Infarction. Basic parameters: 40 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

Myocardial infarction (MI) often leads to reduced cardiorespiratory fitness, poor exercise tolerance, and decreased quality of life. Conventional rehabilitation mainly uses cycle ergometer training but may not adequately improve upper-limb function needed for daily activities. This randomized clinical trial aims to compare the effects of combined arm-leg ergometer endurance training and cycle ergometer training on cardiorespiratory fitness, exercise tolerance, and quality of life in post-MI patients. The study will be conducted in cardiac rehabilitation centers in Pakistan using 40 medically stable post-MI patients divided into two groups. Group A will receive combined arm-leg ergometer training, while Group B will receive cycle ergometer training. Sessions will be conducted 3 times weekly for 6 weeks. Outcomes will be measured using VO₂ peak, 6-minute walk test, and MacNew HRQOL questionnaire, with data analyzed through SPSS version 25.

Detailed description

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.

Interventions

  • Device arm-leg ergometer training
    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 co
  • Device traditional cycle ergometer training
    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

Primary outcome measures

  • cardiorespiratory fitness [Time frame: Baseline and after 6 weeks of intervention]
  • exercise tolerance [Time frame: Baseline and after 6 weeks of intervention]
  • individual quality of life [Time frame: Baseline and after 6 weeks of intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07645040 · REC/RCR & AHS/25/0311

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗