- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Muhammad Iqbal Tariq Tariq, Phd*
- Telefonnummer: 333826752
- E-post: iqbal.tariq@riphah.edu.pk
Studera Kontakt Backup
- Namn: Nimra Noor Noor, MS-CPPT
- Telefonnummer: 03030684869
- E-post: nimranoor358@gmail.com
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
|
|
Experimentell: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
cardiorespiratory fitness
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Nimra Noor, MS-CPPT, Riphah International University Lahore(Gulberg)
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
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Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- REC/RCR & AHS/25/0311
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