- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT06868134
Efficacy of Exercise Methods in Postmenopausal Women: A Clinical Trial
La efectividad de los diferentes métodos de aplicación de ejercicio en mujeres posmenopáusicas
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Beykoz
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Istanbul, Beykoz, Turquía (Türkiye), 34000
- Istanbul Medipol University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Body Composition (Fat Mass, Lean Mass, and BMI) Assessed by Bioelectrical Impedance Analysis (BIA)
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Menopause Symptom Assessment Scale Score
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Otros números de identificación del estudio
- E-10840098-772.02-4975
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .