- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07709429
Qigong Exercise for Muscles Strength and Quality of Life in Colorectal Cancer Patients Undergoing Chemotherapy
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Muscle weakness and fatigue are prevalent side effects experienced by patients undergoing chemotherapy for colorectal cancer. These symptoms can significantly impact daily functioning and overall quality of life. Finding effective treatments for this condition is crucial to improving patient outcomes and quality of life.
Qigong serves as a holistic exercise modality that not only strengthens muscles but also elevates the overall quality of life. Its gentle movements make it accessible to a wide range of individuals, including those undergoing rehabilitation or managing chronic health issues.
Furthermore the need of this study is developed from lack in the quantitative knowledge and information in the published studies about the effect of Qigong on muscle strength and quality of life in colorectal cancer patients undergoing chemotherapy.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Shrouk Mohamed Reda Abd Elaliem, M.Sc
- Número de teléfono: +20 12 71384571
- Correo electrónico: Shorouq.mohamed@nub.edu.eg
Copia de seguridad de contactos de estudio
- Nombre: Khadra Mohammed Ali, PhD
Ubicaciones de estudio
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Giza, Egipto
- Faculty of Physical Therapy, Cairo University
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Contacto:
- Shrouk Mohamed Reda Abd Elaliem, M.Sc
- Número de teléfono: +20 12 71384571
- Correo electrónico: Shorouq.mohamed@nub.edu.eg
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age ranges between 35 and 55 years.
- Male & female patients will participate in the study.
- All patients with colorectal cancer undergoing chemotherapy.
- All patients enrolled to the study will have their informed consent.
- The patients will be instructed to report any side effects during the management.
Exclusion Criteria:
- Presence Patients with psychological disturbance or mental illness.
- Cardiopulmonary disease.
- Hypotensive patients.
- Nerve, muscle, or joint disease, or other malignant tumors affecting movement.
- Autoimmune disease.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Qigong Exercise + Conventional Exercise Program
Participants will receive a supervised Baduanjin Qigong exercise program combined with conventional exercises, including pain-free range-of-motion exercises, low-intensity walking, and physical therapy education.
The intervention will be conducted three times weekly for 12 weeks under physiotherapist supervision, while participants continue their prescribed chemotherapy and routine medical follow-up.
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Participants will receive a supervised Baduanjin Qigong exercise program combined with conventional exercises, including pain-free range-of-motion exercises, low-intensity walking, and physical therapy education.
The intervention will be conducted three times weekly for 12 weeks under physiotherapist supervision, while participants continue their prescribed chemotherapy and routine medical follow-up.
Participants in this arm will receive a conventional exercise program consisting of pain-free range-of-motion exercises for the shoulder, elbow, wrist, hip, knee, and ankle joints, low-intensity walking, and physical therapy education to maintain daily activities.
The intervention will be administered for 12 weeks, with three sessions per week.
Participants will continue their prescribed chemotherapy and routine outpatient medical follow-up throughout the study and will not participate in any additional structured exercise program during the intervention period.
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Comparador activo: Conventional Exercise Program
Participants in this arm will receive a conventional exercise program consisting of pain-free range-of-motion exercises for the shoulder, elbow, wrist, hip, knee, and ankle joints, low-intensity walking, and physical therapy education to maintain daily activities.
The intervention will be administered for 12 weeks, with three sessions per week.
Participants will continue their prescribed chemotherapy and routine outpatient medical follow-up throughout the study and will not participate in any additional structured exercise program during the intervention period.
|
Participants in this arm will receive a conventional exercise program consisting of pain-free range-of-motion exercises for the shoulder, elbow, wrist, hip, knee, and ankle joints, low-intensity walking, and physical therapy education to maintain daily activities.
The intervention will be administered for 12 weeks, with three sessions per week.
Participants will continue their prescribed chemotherapy and routine outpatient medical follow-up throughout the study and will not participate in any additional structured exercise program during the intervention period.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Muscle Strength
Periodo de tiempo: 12 weeks
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Muscle strength of the upper and lower limbs will be assessed using the Lafayette Hand-Held Dynamometer.
Muscle strength will be quantified as the maximum isometric force generated by the tested muscle groups, with higher values indicating greater muscle strength.
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12 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Health-Related Quality of Life
Periodo de tiempo: 12 weeks
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Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36).
The questionnaire evaluates multiple domains of physical and mental health, with domain scores ranging from 0 to 100.
Higher scores indicate better health-related quality of life.
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12 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Amal Mohammed Abd El Baky, PhD, Professor, Cairo University
- Director de estudio: Khadra Mohammed Ali, PhD, Assist Professor, Cairo University
- Director de estudio: Eid Rizk El Gamal, PhD, Assist. Professor, Al-Azhar University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- P.T.REC/012/005843
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.
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