NCT07645040

Brief Summary

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Jun 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress23%
Jun 2026Aug 2026

Study Start

First participant enrolled

June 1, 2026

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 12, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

2 months

First QC Date

June 8, 2026

Last Update Submit

June 8, 2026

Conditions

Keywords

Arm-Leg ErgometerCycle ErgometerMyocardial infarctionQuality of Life

Outcome Measures

Primary Outcomes (3)

  • cardiorespiratory fitness

    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

    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

    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

Study Arms (2)

arm-leg ergometer ergometer

EXPERIMENTAL

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

traditional cycle ergometer

EXPERIMENTAL

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

Interventions

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

arm-leg ergometer ergometer

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

traditional cycle ergometer

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Unstable angina or uncontrolled hypertension.
  • Orthopedic/neurological limitations affecting participants.
  • Arrhythmias
  • Fever
  • Cognitive impairment or non-consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Nimra Noor, MS-CPPT

    Riphah International University Lahore(Gulberg)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Iqbal Tariq Tariq, Phd*

CONTACT

Nimra noor Noor, MS-CPPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Because of the physical nature of the interventions, both participants and investigators will know which treatment is being given. No blinding will be applied.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2026

First Posted

June 12, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

June 12, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share