- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Muhammad Iqbal Tariq Tariq, Phd*
- Telefonnummer: 333826752
- E-mail: iqbal.tariq@riphah.edu.pk
Undersøgelse Kontakt Backup
- Navn: Nimra noor Noor, MS-CPPT
- Telefonnummer: 03030684869
- E-mail: nimranoor358@gmail.com
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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
|
|
Eksperimentel: 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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
cardiorespiratory fitness
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Nimra Noor, MS-CPPT, Riphah International University Lahore(Gulberg)
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- REC/RCR & AHS/25/0311
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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