- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT06868134
Efficacy of Exercise Methods in Postmenopausal Women: A Clinical Trial
A eficácia de diferentes métodos de aplicação de exercícios em mulheres na pós -menopausa
This study aims to evaluate the effectiveness of different exercise methods in improving health outcomes for postmenopausal women. As women go through menopause, they may experience changes such as decreased bone density, muscle weakness, and an increased risk of chronic diseases. Exercise is known to be beneficial in reducing these risks, but the best approach remains unclear.
In this clinical trial, participants will engage in structured exercise programs designed to improve bone health, strength, and overall well-being. The study will compare different types of exercises to determine which method provides the most benefits. By participating in this research, postmenopausal women can contribute to a better understanding of how exercise can enhance health during this stage of life.
This study is safe, and all exercises are guided by professionals. The results will help healthcare providers recommend the most effective exercise strategies for postmenopausal women.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Beykoz
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Istanbul, Beykoz, Turquia (Türkiye), 34000
- Istanbul Medipol University
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Being between 40-65 years of age Having a Body Mass Index (BMI) below 40 Scoring 68 or above on the System Usability Scale Having no orthopedic problems Completing the informed consent form Being within 5 years after a 12-month amenorrhea history
Exclusion Criteria:
- Presence of visual impairments Presence of musculoskeletal system disorders Presence of cognitive impairments Presence of joint range of motion limitations Presence of severe cardiac problems Participation in another program
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Sem intervenção: Control Group
Participants in this group will not receive any intervention |
|
|
Experimental: Supervised Exercise Group
Participants in this group will receive a supervised progressive exercise program including stretching, strengthening, and aerobic exercises. The intervention will be performed 3 times per week with at least one rest day between sessions. |
Participants in this group will receive a supervised progressive exercise program consisting of stretching, strengthening, and aerobic exercises. The intervention will be conducted three times per week with at least one rest day between sessions. |
|
Experimental: Web-Based Exercise Group
Participants in this group will follow a progressive exercise program through the Physitrack web platform. At the beginning and at the end of the 8th week, participants will be assessed. A profile will be created for each participant by the researcher, and the individualized progressive exercise program will be assigned to their profiles. The intervention will be performed 3 times per week with at least one rest day between sessions. |
Participants will follow a structured progressive exercise program through the Physitrack web platform, including stretching, strengthening, and aerobic exercises. The program will be assigned to each participant's profile, and they will complete the exercises three times per week with at least one rest day between sessions. Assessments will be conducted at the beginning and at the end of the 8th week. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Body Composition (Fat Mass, Lean Mass, and BMI) Assessed by Bioelectrical Impedance Analysis (BIA)
Prazo: Baseline and Week 8
|
Body composition (fat mass, lean mass, and BMI) measured using bioelectrical impedance analysis (BIA). Higher fat mass may be associated with lower exercise capacity. |
Baseline and Week 8
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Menopause Symptom Assessment Scale Score
Prazo: Baseline and Week 8
|
Change in menopause symptoms assessed by the Menopause Symptom Assessment Scale. The scale consists of 11 items rated from 0 to 4, with a maximum score of 44. Higher scores indicate worse quality of life. |
Baseline and Week 8
|
|
Fatigue Severity Scale Score
Prazo: Baseline and Week 8
|
Fatigue levels measured using the Fatigue Severity Scale (FSS), which consists of 9 questions scored between 0 and 7. A total score of 28 or above indicates severe fatigue. |
Baseline and Week 8
|
|
Beck Depression Inventory (BDI) Score
Prazo: Baseline and Week 8
|
Depression levels assessed using the Beck Depression Inventory (BDI), with scores categorized into minimal, mild, moderate, and severe depression. A score above 30 indicates severe depression. |
Baseline and Week 8
|
|
Pittsburgh Sleep Quality Index (PSQI) Score
Prazo: Baseline and Week 8
|
Sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI), with a total score range of 0-21. A total score greater than 5 indicates poor sleep quality. |
Baseline and Week 8
|
|
Short Form-36 (SF-36) Quality of Life Scale Score
Prazo: Baseline and Week 8
|
Quality of life will be measured using the Short Form-36 (SF-36) questionnaire, which evaluates physical and emotional well-being across 8 domains. |
Baseline and Week 8
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
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
Outros números de identificação do estudo
- E-10840098-772.02-4975
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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