- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07833358
This Trial Corresponds to the Manuscript Titled: Effects of Tai Chi on Balance and Sleep Quality in Colorectal Cancer Patients Undergoing Chemotherapy
Effect of Tai Chi Exercise Intervention on Physical and Mental Distress of Patients With Colorectal Cancer During Adjuvant Chemotherapy
Colorectal cancer patients receiving adjuvant chemotherapy may experience reduced physical fitness, fatigue, emotional distress, sleep problems, and impaired quality of life. This study evaluated whether a 24-week Tai Chi exercise program could improve physical and psychological outcomes in patients with colorectal cancer undergoing adjuvant chemotherapy.
Participants were randomly assigned to either a Tai Chi exercise group or a usual-care control group. Participants in the Tai Chi group were instructed to perform at least 150 minutes of Tai Chi exercise per week for 24 weeks, while participants in the control group received usual care. Physical fitness, fatigue, depression, anxiety, sleep quality, and quality of life were assessed during the study.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This study used a randomized, two-group, repeated-measures design to evaluate the effects of a 24-week Tai Chi exercise program in patients with colorectal cancer undergoing adjuvant chemotherapy.
Eligible participants were adults aged 20 years or older who had undergone colorectal cancer surgery for the first time and were scheduled to receive six months of adjuvant chemotherapy. Participants were randomly assigned to the Tai Chi exercise group or the usual-care control group using a computer-generated random-number procedure.
Participants assigned to the intervention group received usual care and participated in a 24-week Tai Chi exercise program. They were instructed to complete at least 150 minutes of Tai Chi exercise per week. The exercise could be completed in one or multiple sessions according to the participant's physical condition and treatment schedule. Participants received an instructional video and manual, recorded their daily exercise duration, and were contacted weekly by telephone to assess adherence and address difficulties encountered during exercise.
Participants assigned to the control group received usual care during adjuvant chemotherapy and did not receive the structured Tai Chi exercise program.
Study outcomes included upper- and lower-extremity muscle strength, static and dynamic balance, fatigue, depression, anxiety, sleep quality, and quality of life. Assessments were conducted before the first adjuvant chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment.
A total of 60 participants were enrolled, including 31 participants assigned to the Tai Chi exercise group and 29 assigned to the usual-care control group. Fifty-three participants completed the study assessments.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Taiwan
-
New Taipei City, Taiwan, Taiwan, 251020
- Tamsui Mackay Memorial Hospital
-
Taipei, Taiwan, Taiwan, 104217
- Mackay Memorial Hospital
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Aged 20 years or older
- Underwent colorectal cancer surgery for the first time
- Scheduled to receive six months of adjuvant chemotherapy following colorectal cancer surgery
- No other serious medical condition
- No acute functional decline during hospitalization
- Willing to participate and able to provide written informed consent after receiving an explanation of the study
- Able to communicate in Mandarin Chinese or Taiwanese
- Clinically stable and receiving regular outpatient follow-up
Exclusion Criteria:
- Required radiotherapy or targeted therapy in addition to adjuvant chemotherapy after surgery
- Admitted to an intensive care unit because of trauma surgery, heart failure, end-stage disease, or another serious condition
- Valvular heart disease, atrial fibrillation, cardiomyopathy, myocarditis, uncontrolled chronic disease, or congestive heart failure
- Unable to clearly communicate level of consciousness, symptoms, or feelings
- Severe visual or hearing impairment
- Diagnosed psychiatric disorder
- Medically advised not to exercise
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Tai Chi Exercise Group
Participants received usual care and completed a 24-week Tai Chi exercise program, with a target of at least 150 minutes of Tai Chi exercise per week. |
A 24-week home-based Tai Chi exercise program consisting of slow, low-impact movements, warm-up exercises, muscle-strengthening movements, and cool-down exercises. Participants were instructed to complete at least 150 minutes of Tai Chi exercise per week. The exercise could be completed in one or multiple sessions according to each participant's physical condition and chemotherapy schedule. Participants received an instructional video and manual, recorded their daily exercise duration, and were contacted weekly by telephone to assess adherence and address exercise-related difficulties. |
|
Sem intervenção: Usual Care Control Group
Participants received usual care during adjuvant chemotherapy and did not receive the structured Tai Chi exercise program. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Fatigue Measured by the Brief Fatigue Inventory-Taiwan Form
Prazo: Baseline before the first chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment, over approximately 24 weeks
|
Fatigue was assessed using the Brief Fatigue Inventory-Taiwan Form. The instrument contains three items assessing fatigue severity and six items assessing interference of fatigue with daily functioning. Each item is rated from 0 to 10, with higher scores indicating greater fatigue severity or interference. Mean fatigue severity and fatigue interference scores were calculated. |
Baseline before the first chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment, over approximately 24 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Grip Strength
Prazo: Baseline before the first chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment, over approximately 24 weeks
|
Upper-extremity muscle strength was assessed using a Camry EH101 electronic handgrip dynamometer. Participants performed the test three times with their dominant hand while standing with their arms naturally positioned at their sides. A rest period of 1 to 2 minutes was provided between measurements. The highest value from the three measurements was recorded in kilograms. Higher values indicate greater grip strength. |
Baseline before the first chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment, over approximately 24 weeks
|
|
Change in Lower-Extremity Muscle Strength Measured by the 30-Second Chair Stand Test
Prazo: Baseline before the first chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment, over approximately 24 weeks
|
Lower-extremity muscle strength and endurance were assessed using the 30-Second Chair Stand Test. Participants began seated in a 0.43-meter-high chair with their arms crossed over their chest and were instructed to rise to a full standing position and return to a seated position as many times as possible within 30 seconds. The total number of correctly completed stands was recorded. Higher numbers indicate better lower-extremity muscle strength and endurance. |
Baseline before the first chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment, over approximately 24 weeks
|
|
Change in Depression Severity Measured by the Beck Depression Inventory-II
Prazo: Baseline before the first chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment, over approximately 24 weeks
|
Depressive symptoms were assessed using the Chinese version of the Beck Depression Inventory-II (BDI-II). The instrument contains 21 items assessing cognitive, affective, and somatic symptoms of depression. Each item is rated from 0 to 3, producing a total score ranging from 0 to 63. Higher scores indicate greater severity of depressive symptoms. |
Baseline before the first chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment, over approximately 24 weeks
|
|
Change in Anxiety Severity Measured by the Beck Anxiety Inventory
Prazo: Baseline before the first chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment, over approximately 24 weeks
|
Anxiety symptoms were assessed using the Chinese version of the Beck Anxiety Inventory (BAI). The instrument contains 21 items assessing subjective anxiety, panic-related symptoms, and somatic symptoms of anxiety. Each item is rated from 0 to 3, producing a total score ranging from 0 to 63. Higher scores indicate greater severity of anxiety symptoms. |
Baseline before the first chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment, over approximately 24 weeks
|
|
Change in Sleep Quality Measured by the Pittsburgh Sleep Quality Index
Prazo: Baseline before the first chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment, over approximately 24 weeks
|
Sleep quality was assessed using the Chinese version of the Pittsburgh Sleep Quality Index (PSQI). The instrument contains 19 self-rated items that generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each component is scored from 0 to 3, producing a global score ranging from 0 to 21. Higher scores indicate poorer sleep quality. |
Baseline before the first chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment, over approximately 24 weeks
|
|
Change in Health-Related Quality of Life Measured by the EORTC QLQ-C30
Prazo: Baseline before the first chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment, over approximately 24 weeks
|
Health-related quality of life was assessed using the Chinese version of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The 30-item instrument includes five functional scales, three symptom scales, six single-item symptom measures, and a global health status/quality-of-life scale. Scale scores range from 0 to 100. Higher scores on the functional and global health status/quality-of-life scales indicate better functioning and quality of life, whereas higher scores on the symptom scales and single-item measures indicate greater symptom burden. |
Baseline before the first chemotherapy treatment, before the seventh chemotherapy treatment, and two weeks after the twelfth chemotherapy treatment, over approximately 24 weeks
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
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
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças do Sistema Nervoso
- Transtornos Mentais, Desordem Mental
- Neoplasias por local
- Neoplasias
- Doenças Intestinais
- Sintomas Comportamentais
- Neoplasias gastrointestinais
- Neoplasias do Aparelho Digestivo
- Doenças do aparelho digestivo
- Doenças Gastrointestinais
- Neoplasias Intestinais
- Doenças retais
- Doenças do cólon
- Distúrbios do Sono Vigília
- Distúrbios do Sono Intrínsecos
- Dissônias
- Condições Patológicas, Sinais e Sintomas
- Comportamento
- Sinais e sintomas
- Transtornos de ansiedade
- Neoplasias Colorretais
- Depressão
- Fadiga
- Distúrbios de Iniciação e Manutenção do Sono
Outros números de identificação do estudo
- 20MMHIS382e
- 20MMHIS382e (Outro identificador: Mackay Memorial Hospital Institutional Review Board approval number)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Individual participant data will not be shared because the informed consent obtained from participants did not include authorization for public or external sharing of individual-level data. Data sharing is also restricted to protect participant privacy and confidentiality in accordance with the approved study protocol and institutional review board requirements.
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 .