Efeitos do Exercício Baduanjin na Melhoria da Saúde em Adultos Jovens e de Meia-Idade Sedentários
Um Ensaio Multicêntrico, Aleatorizado e Controlado para Avaliar a Eficácia e os Mecanismos do Baduanjin na Melhoria dos Resultados de Saúde em Adultos Jovens e de Meia-Idade Sedentários
The goal of this clinical trial is to learn if a 12-week Baduanjin exercise program can improve health in sedentary young and middle-aged adults. The main questions it aims to answer are:
- Does the Baduanjin program improve participants' cardiorespiratory fitness (measured as peak oxygen uptake)?
- Does it improve their body composition, muscle strength, balance, and flexibility?
- Does it reduce their daily sitting time?
Researchers will compare the Baduanjin training group to a health education control group to see if Baduanjin is more effective in improving these health outcomes.
Participants will:
- Be randomly assigned to one of the two groups.
- If in the Baduanjin group, attend supervised group sessions and practice at home for 12 weeks.
- Complete a series of assessments at the beginning, middle, and end of the study, including fitness tests, body measurements, and questionnaires.
Visão geral do estudo
Status
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Jingyi Ren, M.D., Chief Physician
- Número de telefone: 18600195099
- E-mail: renjingyi@cjfh.org.cn
Locais de estudo
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, China, 100029
- Recrutamento
- China-Japan Friendship Hospital
-
Contato:
- Jingyi Ren, Doctor
- Número de telefone: +86 17367938350
- E-mail: 1220193509@qq.com
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Adults aged 18 to 59 years
- Sedentary and physically inactive, defined as: (a) self-reported sitting time ≥ 8 hours per day, AND (b) not meeting the World Health Organization (WHO) recommended level of physical activity ( engaging in < 150 minutes of moderate-to-vigorous intensity physical activity per week, assessed by the International Physical Activity Questionnaire [IPAQ])
- In good general health as self-reported, and free from any known diseases
- Willing and able to provide written informed consent
Exclusion Criteria:
- Contraindications to cardiopulmonary exercise testing
- Currently participating in, or planning to participate within the next 3 months, in any other structured exercise or behavioral intervention program
- Pregnancy, lactation, or planning to become pregnant during the study period
- Inability to understand or comply with the study procedures
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Baduanjin Training Group
Participants in this group will receive a 12-week Baduanjin exercise program. The program consists of supervised group sessions combined with home-based practice, with a frequency of 5 sessions per week. Each session lasts 60 minutes, including warm-up, standardized Baduanjin practice, and cool-down. The Baduanjin exercises follow a standardized protocol. |
A 12-week, standardized Baduanjin exercise program. Participants will complete 5 sessions per week, each lasting 60 minutes (including warm-up, Baduanjin practice, and cool-down). The program includes both supervised group sessions and guided home practice. |
|
Outro: Health Education Control Group
Participants in this group will receive general health education, which includes recommendations on physical activity types and duration (e.g., following the WHO guidelines). However, they will not be enrolled in any structured, supervised exercise program. They will be instructed to maintain their usual lifestyle throughout the study period. |
Participants will receive general health education (including recommendations on physical activity types and duration), but will not be enrolled in any structured or supervised exercise program. They will be instructed to maintain their usual lifestyle. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Peak Oxygen Uptake (VO₂peak) assessed by Cardiopulmonary Exercise Testing
Prazo: at baseline and Week 13.
|
Measured by Cardiopulmonary Exercise Testing (CPET). |
at baseline and Week 13.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Alteração do Tempo Despendido em Comportamento Sedentário avaliada pelo Questionário Internacional de Atividade Física (IPAQ)
Prazo: na linha de base e na Semana 13.
|
na linha de base e na Semana 13.
|
|
|
Alteração na Potência Média de Extensão do Joelho avaliada por Dinamometria Isocinética
Prazo: no início, na Semana 8 e na Semana 13.
|
no início, na Semana 8 e na Semana 13.
|
|
|
Alteração no Índice de Fadiga da Extensão do Joelho avaliada por Dinamometria Isocinética
Prazo: no início, na Semana 8 e na Semana 13.
|
no início, na Semana 8 e na Semana 13.
|
|
|
Alteração na Potência Média da Flexão do Joelho avaliada por Dinamometria Isocinética
Prazo: no início, na 8ª semana e na 13ª semana
|
no início, na 8ª semana e na 13ª semana
|
|
|
Alteração no Índice de Fadiga da Flexão do Joelho avaliada por Dinamometria Isocinética
Prazo: no início, na Semana 8 e na Semana 13
|
no início, na Semana 8 e na Semana 13
|
|
|
Alteração na Potência Média da Flexão do Ombro avaliada por Dinamometria Isocinética
Prazo: no início, na Semana 8 e na Semana 13
|
no início, na Semana 8 e na Semana 13
|
|
|
Alteração no Índice de Fadiga da Flexão do Ombro avaliado por Dinamometria Isocinética
Prazo: no início do estudo, na Semana 8 e na Semana 13
|
no início do estudo, na Semana 8 e na Semana 13
|
|
|
Alteração na Potência Média da Abdução do Ombro avaliada por Dinamometria Isocinética
Prazo: no início, na Semana 8 e na Semana 13
|
no início, na Semana 8 e na Semana 13
|
|
|
Alteração no Índice de Fadiga da Abdução do Ombro avaliada por Dinamometria Isocinética
Prazo: na linha de base, na Semana 8 e na Semana 13
|
na linha de base, na Semana 8 e na Semana 13
|
|
|
Alteração na Potência Média da Extensão do Cotovelo avaliada por Dinamometria Isocinética
Prazo: no início, na Semana 8 e na Semana 13
|
no início, na Semana 8 e na Semana 13
|
|
|
Alteração do Índice de Fadiga na Extensão do Cotovelo avaliado por Dinamometria Isocinética
Prazo: na linha de base, Semana 8 e Semana 13
|
na linha de base, Semana 8 e Semana 13
|
|
|
Alteração na Potência Média de Flexão do Cotovelo avaliada por Dinamometria Isocinética
Prazo: no início, na semana 8 e na semana 13
|
no início, na semana 8 e na semana 13
|
|
|
Alteração do Índice de Fadiga da Flexão do Cotovelo avaliado por Dinamometria Isocinética
Prazo: no início, na 8ª semana e na 13ª semana
|
no início, na 8ª semana e na 13ª semana
|
|
|
Alteração na Massa Muscular avaliada por Análise de Impedância Bioelétrica
Prazo: na linha de base e na Semana 13.
|
na linha de base e na Semana 13.
|
|
|
Alteração na Percentagem de Gordura Corporal avaliada por Análise de Bioimpedância Elétrica
Prazo: na linha de base e na Semana 13.
|
na linha de base e na Semana 13.
|
|
|
Alteração da Massa Livre de Gordura avaliada por Análise de Impedância Bioelétrica
Prazo: na linha de base e na Semana 13.
|
na linha de base e na Semana 13.
|
|
|
Alteração na Altura do Centro de Massa durante o Exercício Baduanjin avaliada por Captura de Movimento 3D
Prazo: na linha de base e na Semana 13
|
na linha de base e na Semana 13
|
|
|
Alteração na Eletromiografia Integrada (iEMG) durante o Exercício Baduanjin avaliada por Eletromiografia de Superfície
Prazo: na linha de base e na Semana 13
|
na linha de base e na Semana 13
|
|
|
Alteração na Amplitude da Raiz Quadrada Média (RMS) durante o exercício Baduanjin avaliada por Eletromiografia de Superfície
Prazo: na linha de base e na Semana 13
|
na linha de base e na Semana 13
|
|
|
Percentagem de Sessões de Baduanjin Prescritas Concluídas
Prazo: Até à conclusão do estudo, até à Semana 13.
|
Até à conclusão do estudo, até à Semana 13.
|
|
|
Change in Sit-and-Reach Distance
Prazo: at baseline, Week 8, and Week 13.
|
Assessed by the standard sit-and-reach test. |
at baseline, Week 8, and Week 13.
|
|
Change in Active Range of Motion of the Shoulder, Hip, Knee, and Ankle joints assessed by Goniometry
Prazo: at baseline, Week 8, and Week 13.
|
Measured using a goniometer |
at baseline, Week 8, and Week 13.
|
|
Scores on the Exercise Benefits/Barriers Scale (EBBS)
Prazo: at baseline and Week 13
|
The scale consists of two subscales: the Exercise Benefits Subscale (29 items) and the Exercise Barriers Subscale (14 items). The total score ranges from 43 to 172, with a higher score indicating a more positive perception towards exercise. |
at baseline and Week 13
|
|
Change in Knee Extension Peak Torque assessed by Isokinetic Dynamometry
Prazo: at baseline, Week 8, and Week 13.
|
Maximum torque generated during knee extension |
at baseline, Week 8, and Week 13.
|
|
Change in Knee Extension Total Work assessed by Isokinetic Dynamometry
Prazo: at baseline, Week 8, and Week 13.
|
Total work performed during repeated maximal knee extension contractions. |
at baseline, Week 8, and Week 13.
|
|
Change in Knee Flexion Peak Torque assessed by Isokinetic Dynamometry
Prazo: at baseline, Week 8, and Week 13
|
Maximum torque generated during Knee Flexion measured at a preset angular velocity |
at baseline, Week 8, and Week 13
|
|
Change in Knee Flexion Total Work assessed by Isokinetic Dynamometry
Prazo: at baseline, Week 8, and Week 13
|
Total work performed during repeated maximal Knee Flexion contractions |
at baseline, Week 8, and Week 13
|
|
Change in Shoulder Flexion Peak Torque assessed by Isokinetic Dynamometry
Prazo: at baseline, Week 8, and Week 13
|
Maximum torque generated during Shoulder Flexion, measured at a preset angular velocity. |
at baseline, Week 8, and Week 13
|
|
Change in Shoulder Flexion Total Work assessed by Isokinetic Dynamometry
Prazo: at baseline, Week 8, and Week 13
|
Total work performed during repeated maximal Shoulder Flexion contractions |
at baseline, Week 8, and Week 13
|
|
Change in Shoulder Abduction Peak Torque assessed by Isokinetic Dynamometry
Prazo: at baseline, Week 8, and Week 13
|
Maximum torque generated during Shoulder Abduction , measured at a preset angular velocity |
at baseline, Week 8, and Week 13
|
|
Change in Shoulder Abduction Total Work assessed by Isokinetic Dynamometry
Prazo: at baseline, Week 8, and Week 13
|
Total work performed during repeated maximal Shoulder Abduction contractions |
at baseline, Week 8, and Week 13
|
|
Change in Elbow Extension Peak Torque assessed by Isokinetic Dynamometry
Prazo: at baseline, Week 8, and Week 13
|
Maximum torque generated during Elbow Extension, measured at a preset angular velocity |
at baseline, Week 8, and Week 13
|
|
Change in Elbow Extension Total Work assessed by Isokinetic Dynamometry
Prazo: at baseline, Week 8, and Week 13
|
Total work performed during repeated maximal Elbow Extension contractions |
at baseline, Week 8, and Week 13
|
|
Change in Elbow Flexion Peak Torque assessed by Isokinetic Dynamometry
Prazo: at baseline, Week 8, and Week 13
|
Maximum torque generated during Elbow Flexion, measured at a preset angular velocity |
at baseline, Week 8, and Week 13
|
|
Change in Elbow Flexion Total Work assessed by Isokinetic Dynamometry
Prazo: at baseline, Week 8, and Week 13
|
Total work performed during repeated maximal Elbow Flexion contractions |
at baseline, Week 8, and Week 13
|
|
Change in Rhythmic Weight Shift (RWS) Score assessed by Computerized Dynamic Posturography
Prazo: at baseline, Week 8, and Week 13.
|
Measured using a computerized dynamic posturography system. |
at baseline, Week 8, and Week 13.
|
|
Change in Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) Score assessed by Computerized Dynamic Posturography
Prazo: at baseline, Week 8, and Week 13.
|
Measured using a computerized dynamic posturography system. |
at baseline, Week 8, and Week 13.
|
|
Change in Sensory Organization Test (SOT) Composite Score assessed by Computerized Dynamic Posturography
Prazo: at baseline, Week 8, and Week 13.
|
Measured using a computerized dynamic posturography system. |
at baseline, Week 8, and Week 13.
|
|
Change in Motor Control Test (MCT) Latency assessed by Computerized Dynamic Posturography
Prazo: at baseline, Week 8, and Week 13.
|
Measured using a computerized dynamic posturography system. |
at baseline, Week 8, and Week 13.
|
|
Change in Limits of Stability (LOS) Score assessed by Computerized Dynamic Posturography
Prazo: at baseline, Week 8, and Week 13.
|
Measured using a computerized dynamic posturography system. |
at baseline, Week 8, and Week 13.
|
|
Change in Waist-to-Hip Ratio
Prazo: at baseline and Week 13.
|
Ratio of waist circumference to hip circumference |
at baseline and Week 13.
|
|
Change in Center of Mass Sway Amplitude during Baduanjin Exercise assessed by 3D Motion Capture
Prazo: at baseline and Week 13
|
Magnitude of anteroposterior and mediolateral displacement of the body's center of mass during static postures of Baduanjin, analyzed using a markerless 3D motion capture system |
at baseline and Week 13
|
|
Change in Joint Range of Motion during Baduanjin Exercise assessed by 3D Motion Capture
Prazo: at baseline and Week 13
|
Angular displacement of primary joints during the performance of Baduanjin movements, analyzed using a markerless 3D motion capture system. |
at baseline and Week 13
|
|
Change in Glycemic Control Biomarkers
Prazo: at baseline and Week 13.
|
Fasting venous blood samples will be analyzed for indicators of glucose metabolism, such as glycated hemoglobin (HbA1c) and fasting insulin. |
at baseline and Week 13.
|
|
Change in Lipid Profile
Prazo: at baseline and Week 13.
|
Fasting venous blood samples will be analyzed for indicators of lipid metabolism, including total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C). |
at baseline and Week 13.
|
|
Change in Inflammatory and Neurotrophic Biomarkers
Prazo: at baseline and Week 13.
|
Fasting venous blood samples will be analyzed for inflammatory markers (e.g., high-sensitivity C-reactive protein [hs-CRP], interleukin-6 [IL-6], tumor necrosis factor-alpha [TNF-α]) and brain-derived neurotrophic factor (BDNF). |
at baseline and Week 13.
|
|
Baduanjin Movement Quality Score assessed by Blinded Expert Review (100-point scale)
Prazo: at Week 13
|
Score assessed by blinded experts using a standardized 100-point scoring rubric. Scores range from 0 to 100, with a higher score indicating better movement quality. |
at Week 13
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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
- Shoufa 2024-1-4061
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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 .