Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

El ejercicio como medicina: Un enfoque no farmacológico para los síntomas de la menopausia

21 de septiembre de 2026 actualizado por: Sofia Ryman Ryman Augustsson, Linnaeus University

Ejercicio como Medicina: Un Enfoque No Farmacológico para los Síntomas de la Menopausia

The aim of this clinical trial is to evaluate the effects of different forms of physical exercise in women experiencing menopausal symptoms. Specifically, the project investigates the effects of: (1) strength training on women's perceived menopausal symptoms; (2) dance-based exercise on women's perceived menopausal symptoms; and (3) adherence to structured, digital home-based exercise programs.

The following research questions will be addressed within the framework of the project:

Does regular strength training reduce women's perceived menopausal symptoms?

To what extent does strength training influence menopausal symptoms and sleep quality in women?

What is the level of adherence to a digital, home-based strength training program among women with menopausal symptoms?

Does regular dance-based physical activity reduce women's perceived menopausal symptoms?

To what extent does dance-based physical activity influence menopausal symptoms and sleep quality in women?

What is the level of adherence to a digital, home-based dance exercise program among women with menopausal symptoms?

Which exercise protocol-strength training or dance-based exercise-has the greatest effect on perceived menopausal symptoms?

The researchers will compare a digital, home-based strength training program with a digital, home-based dance exercise program, as well as with a control group, to determine which type of exercise has the greatest effect on menopausal symptoms and sleep quality.

Participants will:

Perform either dance-based exercise or strength training for 8 weeks, three times per week, following a structured program of approximately 30 minutes per session, or participate as part of the control group.

Complete validated questionnaires assessing menopausal health, including somatic, psychological, and sexual symptoms, as well as perceived quality of life and sleep quality, both before and after the intervention.

Maintain a training diary to monitor adherence and progression, including increases in training intensity

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

This clinical trial will be conducted as a randomized controlled trial, in which participants will be randomly assigned to either an intervention group or a control group. The study will begin with a pilot phase including 45 menopausal women, who will be randomly allocated to one of three groups: (1) strength training intervention (n = 15); (2) dance-based training intervention (n = 15); or (3) control group (n = 15).

Following completion of the pilot study, a full-scale intervention trial will be conducted. The sample size for the main study will be determined by a power calculation based on the results obtained from the pilot phase.

The study will begin with an assessment of participants' menopausal health, including somatic, psychological, and sexual symptoms, as well as perceived quality of life and sleep quality. These outcomes will be measured using the Menopause Rating Scale (MRS) and the Pittsburgh Sleep Quality Index (PSQI).The training protocols will be conducted over an 8-week period, with sessions performed three times per week according to a structured program lasting approximately 30 minutes per session. Two weeks after completion of the intervention, participants will be reassessed using the same instruments, with questionnaires distributed electronically via SurveyMonkey®.

The intervention will begin with a digital introductory meeting, during which participants will receive information materials on menopausal symptoms and a detailed review of the training program and study procedures. Participants in the control group will continue their usual daily activities without any prescribed intervention throughout the 8-week study period. Participants in the control group will be assessed using both instruments on two occasions, with an 8-week interval between assessments. Upon completion of the study, control group participants will be offered access to both intervention programs, as well as the results from Studies 1 and 2.

Throughout the study period, participants will be instructed not to introduce any additional forms of exercise or make changes to existing physical activity habits. The full-scale intervention is planned to be conducted over a 15-week period with a potentially larger sample size.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

45

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Kalmar, Suecia, 391 82
        • Reclutamiento
        • Sofia Ryman Augustsson
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

45 años a 55 años (Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Femenino

Descripción

Inclusion Criteria:

  • Biological female sex
  • Age 45-55 years
  • Experiencing menopausal symptoms, defined as irregular or altered menstruation plus at least one of the following:
  • Hot flashes or sweating
  • Sleep problems
  • Mood swings or depression
  • Dry mucous membranes
  • Recurrent urinary tract infections or overactive bladder
  • Joint pain
  • Decreased libido
  • Weight gain

Exclusion Criteria:

  • Have taken medication or natural remedies for menopausal symptoms in the past 2 months
  • Menopause due to illness or surgical intervention
  • Medical conditions that contraindicate participation in the exercise intervention
  • Engaged in physical activity for ≥150 minutes per week, including ≥ 75 minutes at high intensity

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Control

No intervention

Experimental: Strength training

Strength training intervention.

The strength training intervention consists of an 8-week program performed 3 times per week, with sessions lasting ~30 minutes. Designed by a licensed physiotherapist, the program targets major muscle groups and includes a warm-up followed by structured exercises.

Training uses body weight and simple household equipment, such as chairs and filled water bottles, at an intensity of 8-12 repetition maximum. Each exercise has three to four difficulty levels. Before starting, participants test and select an appropriate level for each exercise to ensure correct intensity.

Participants perform at a level allowing at least eight repetitions and progress once they can complete more than twelve. This enables individualized, progressive training. After each session, participants record the difficulty level and number of repetitions in a training diary. For the full-scale intervention, exercise selection, intensity, and volume may be adjusted, and the program will be extended to 15 weeks.

Experimental: Dance-based training

Dance-based training intervention.

Participants in the dance-based intervention will exercise three times per week at moderate intensity, following a structured 30-minute program performed individually at home via pre-recorded sessions.

After each session, participants will complete a training diary and rate perceived exertion using the Borg RPE scale (6-20), targeting at least moderate intensity (RPE ≥ 14), adjusting effort accordingly.

The program was developed and recorded by a licensed physiotherapist, pilot-tested with a small group, and reviewed by a supervising expert who provided feedback. Participants can ask questions and receive guidance on performing the exercises.

For the full-scale intervention, exercise selection, intensity, and volume may be refined, and the program will be conducted over 15 weeks.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Menopause Rating Scale (MRS)
Periodo de tiempo: 2 times: 1) Baseline: Day 1 and 2) Post intervention: week 8

The Menopause Rating Scale (MRS) consists of 11 items grouped into three dimensions:

  • Somatic Symptoms: Hot flashes, joint pain, and related physical complaints.
  • Psychological Symptoms: Depressive mood, irritability, anxiety, and similar issues.
  • Urogenital Symptoms: Bladder problems, vaginal dryness, and related concerns. Each item is rated on a 5-point Likert scale from 0 (not present) to 4 (very severe). The total score, calculated by summing all items, provides an overall measure of menopausal symptom severity. Thus, total score ranging from 0-44.
2 times: 1) Baseline: Day 1 and 2) Post intervention: week 8

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Pittsburgh Sleep Quality Index (PSQI)
Periodo de tiempo: 2 times: 1) Baseline: Day 1 and 2) Post intervention: week 8

Sleep quality is assessed using the Pittsburgh Sleep Quality Index (PSQI), which evaluates seven components: 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, and a global score is calculated by summing the components. Higher scores indicate poorer sleep quality. The Pittsburgh Sleep Quality Index (PSQI) generates a global score ranging from 0 to 21, where a score greater than 5 typically indicates poor sleep quality. This threshold serves as a clinical benchmark, with higher scores correlating with increased severity of sleep disturbances.

2 times: 1) Baseline: Day 1 and 2) Post intervention: week 8

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de noviembre de 2025

Finalización primaria (Estimado)

1 de mayo de 2027

Finalización del estudio (Estimado)

1 de diciembre de 2027

Fechas de registro del estudio

Enviado por primera vez

16 de diciembre de 2025

Primero enviado que cumplió con los criterios de control de calidad

9 de enero de 2026

Publicado por primera vez (Actual)

20 de enero de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

21 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 2025-06613-01
  • 2025 (Subvención/contrato del NIH de EE. UU.)

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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. .