- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07709429
Qigong Exercise for Muscles Strength and Quality of Life in Colorectal Cancer Patients Undergoing Chemotherapy
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Shrouk Mohamed Reda Abd Elaliem, M.Sc
- Número de telefone: +20 12 71384571
- E-mail: Shorouq.mohamed@nub.edu.eg
Estude backup de contato
- Nome: Khadra Mohammed Ali, PhD
Locais de estudo
-
-
-
Giza, Egito
- Faculty of Physical Therapy, Cairo University
-
Contato:
- Shrouk Mohamed Reda Abd Elaliem, M.Sc
- Número de telefone: +20 12 71384571
- E-mail: Shorouq.mohamed@nub.edu.eg
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
|
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.
|
|
Comparador Ativo: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Muscle Strength
Prazo: 12 weeks
|
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.
|
12 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Health-Related Quality of Life
Prazo: 12 weeks
|
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.
|
12 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: Amal Mohammed Abd El Baky, PhD, Professor, Cairo University
- Diretor de estudo: Khadra Mohammed Ali, PhD, Assist Professor, Cairo University
- Diretor de estudo: Eid Rizk El Gamal, PhD, Assist. Professor, Al-Azhar University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- P.T.REC/012/005843
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .