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

June 8, 2026 updated by: Riphah International University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

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Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
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 consumption, thereby potentially enhancing improvements in VO₂ peak and overall cardiovascular efficiency
Experimental: 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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
cardiorespiratory fitness
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nimra Noor, MS-CPPT, Riphah International University Lahore(Gulberg)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/RCR & AHS/25/0311

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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