- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07713017
Combined Effects of Aerobic Exercise and Strength Training Among Post CABG Patients
Combined Effects of Aerobic Exercise and Strength Training on Functional Capacity, Cardiorespiratory Fitness and Quality of Life With Cardiac Rehabilitation Phase II Among Post CABG Patients
Title of study Combined effects aerobic exercise and strength training on functional capacity, cardiorespiratory fitness and quality of life with cardiac rehabilitation phase II among post CABG patients Objective (s) of the study To investigate the combined effects of aerobic exercise and strength training on functional capacity, cardiorespiratory fitness and quality of life with cardiac rehabilitation phase II among post CABG patients.
Methodology (Design, sample size, sampling technique, Study setting, inclusion and exclusion criteria and Tool) Design: Randomized Controlled Trial Sample Size: 42 patients Sampling Technique: Convenient sampling technique will be used for selection of patient after that simple random sampling technique will be used for randomization among groups Study Setting: Hospital Setting SF-12, 6-min walk test, VO2 max, step test This study will not harm any fundamental rights of the patients and will consider and respect the preferences of patients.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Coronary artery bypass grafting (CABG) is a common surgical procedure for coronary artery disease (CAD). Post-CABG patients often experience decreased functional capacity, muscle strength, and quality of life due to prolonged bed rest, surgical trauma, and underlying cardiovascular disease. Cardiac Rehabilitation after coronary artery bypass graft surgery is necessary to prevent complications, improve functioning, and alleviate symptoms. Aerobic exercises and strength training are used in CR, but their combined effects on post-CABG patients are not well understood. The objective of this study will be to investigate the combined effects of aerobic exercise and strength training on functional capacity, cardiorespiratory fitness and quality of life with cardiac rehabilitation phase II among post CABG patients.
Study design will be randomized controlled trial. 42 patients will be included in study. Data will be collected from Imran Idrees hospital, Sialkot. Convenient sampling technique will be used for selection of patient after that simple random sampling technique for randomization among groups. Study will be conducted within 10 months after approval of synopsis. The SF-12 questionnaire will be used for quality of life, 6-minute walk test for functional capacity, step test and VO2max for cardiorespiratory fitness. Both genders aged between 30 to 60 years with stable cardiovascular condition and no other comorbidities will be included in this study. Participants with any musculoskeletal or neurological impairment and symptoms of significant myocardial ischemia, including chest pain and any history of fracture or surgery will be excluded from this study. Patients will be divided in to two groups. Group A will be assigned aerobic exercise and Group B will be assigned aerobic exercise and strength training. Pre and post values for functional capacity, cardiorespiratory fitness and quality of life will be recorded. Data will be analyzed by using SPSS version 24. After testing the Normality of data by applying Shapiro-wilk test, paired sample t-test/ independent t-test / Anova test to find which technique will be more beneficial for post CABG patients.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Muhammad Iqbal Tariq, pHD
- Número de teléfono: 333826752
- Correo electrónico: iqbal.tariq@riphah.edu.pk
Copia de seguridad de contactos de estudio
- Nombre: Misdaq Batool, MS PT
- Número de teléfono: 03496166611
- Correo electrónico: misdaaqbatool@yahoo.com.ph
Ubicaciones de estudio
-
-
Punjab Province
-
Sialkot, Punjab Province, Pakistán, 40100
- Reclutamiento
- Imran Idrees teaching hospital sialkot
-
Contacto:
- Misdaq Batool, MS PT
- Número de teléfono: 03466584498
- Correo electrónico: misdaaqbatool@yahoo.com.ph
-
Investigador principal:
- Nida Khalid, MS PT
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
Both genders (male, female)
- Patient who underwent a successful CABG (no complications during surgery and/or in the following weeks)
- Patients willing to participate in the phase II cardiac rehabilitation program.
- Age between 30 to 60 years
- Patients having no impairment in the musculoskeletal system
Exclusion Criteria:
Patients with unstable congestive heart failure and symptoms of significant myocardial ischemia, including chest pain
- Patients with uncontrolled diabetes mellitus or hypertension.
- Patients with any motor or neurological impairment
- Patients with severe disturbance of consciousness, having an orthopedic problem and critical limb ischemia
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: aerobic exercise
Aerobic exercise refers to the type of repetitive, structured physical activity that requires the body's metabolic system to use oxygen to produce energy.
Aerobic exercise improves the capacity of the cardiovascular system to uptake and transport oxygen.
Aerobic exercise training intensity is the most important variable in improving CRF during CR for most patients.
Upper limb cycle ergometry is a form of aerobic exercise that can be tailored to individual needs.
In the described protocol, patients perform 5 minutes of active exercise followed by 2 minutes of recovery, maintaining 20-30 rotations per minute.
Moderate-intensity continuous aerobic training (MCT) is defined as 60% to 85% of peak heart rate and/or RPE of 12 to 14 on the 6 to 20 scale.
|
Aerobic Exercise Plan:
|
|
Comparador activo: Aerobic Exercise and strength training
supervised exercise sessions 3 times per week for 6 months.
Thus, in addition to the aerobic exercise training (as above), upper extremity resistance exercise was initially prescribed at 30% of 1RM, increasing to a maximum of 70% of 1RM by 4 weeks.
Seventy percent of 1RM is in the comfortably hard range (5-7 on the Borg 1-10 scale, which is comparable to 13-15 on the 6-20 Borg scale).
Each exercise repetition involved a slow controlled movement with approximately 2 sec of concentric lifting and 4 sec of eccentric lowering.
Proper breathing techniques were enforced (with expiration during concentric lifting and inspiration during eccentric lowering).
|
Cool-down (5-10 minutes): - Static stretching (e.g., bicep, triceps, chest muscles) |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Six-Minute Walk Test (6MWT)
Periodo de tiempo: 5 weeks
|
The six-minute walk test (6MWT) is a simple test that objectively evaluates a patient's functional capacity.
This simple walk test is particularly applicable in the CAD population due to the risk of acute cardiac events associated with the gold standard maximal exercise testing for assessing functional capacity.
The 6MWT requires a 30-m, flat, hard walking path, a stopwatch, a lap counter and two cones to mark the turning points.
The patients were instructed to walk as far as possible along the pathway, in 6 minutes.
During the test encouragement was not given and only asked about their conditions.
At the end, total walked distance was measured and recorded
|
5 weeks
|
|
Step test
Periodo de tiempo: 5 weeks
|
The 6 min step test is a safe, valid, sensitive, and reproducible tool for evaluating cardiorespiratory fitness.
The 6MST was shown to be a safe and reliable field test to assess exercise tolerance in a sample of very deconditioned adults at risk of CVD
|
5 weeks
|
|
Vo2 max
Periodo de tiempo: 5 weeks
|
Vo2 max was estimated using a graded exercise test.
Oxygen consumption was measured using metabolic gas analyzer.
In this research VO2 Max will be measured through a submaximal 6 mint walk test
|
5 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
SF-12 Questionnaire
Periodo de tiempo: 5 weeks
|
The SF-12 are multi-item generic health surveys intended to measure general health.
The SF 12 is a shorter version of the SF-36 and uses only 12 questions to measure functional health and well-being from the patient's perspective.
SF-12 were first published in 1992 and 1996, respectively, with the revised versions of both questionnaires published in 2000.
SF-12 measure 8 health domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health.
The SF-12 consists of 12 items: 2 items on physical functioning, 2 items on role physical, 1 item on bodily pain, 1 item on general health, 1 item on vitality, 1 item on social functioning, 2 items on role emotional, and 2 items on mental health.
|
5 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Arjumand Bano, MS, Riphah International University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Actividad motora
- Movimiento
- Fenómenos fisiológicos musculoesqueléticos
- Fenómenos fisiológicos musculoesqueléticos y neuronales
- Terapéutica
- Modalidades de fisioterapia
- Atención al paciente
- Terapia de ejercicio
- Rehabilitación
- Cuidado por los convalecientes
- Continuidad de la atención al paciente
- Acondicionamiento físico, humano
- Ejercicio
- Entrenamiento de resistencia
Otros números de identificación del estudio
- REC/RCR & AHS/25/0301
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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. .