Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

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

8 de junio de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

40

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

  • Nombre: Nimra Noor Noor, MS-CPPT
  • Número de teléfono: 03030684869
  • Correo electrónico: nimranoor358@gmail.com

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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
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
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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
cardiorespiratory fitness
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Nimra Noor, MS-CPPT, Riphah International University Lahore(Gulberg)

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de junio de 2026

Finalización primaria (Estimado)

1 de agosto de 2026

Finalización del estudio (Estimado)

1 de agosto de 2026

Fechas de registro del estudio

Enviado por primera vez

8 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

8 de junio de 2026

Publicado por primera vez (Actual)

12 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

12 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

8 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • REC/RCR & AHS/25/0311

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .