Exercise as Medicine: A Non-Pharmacological Approach to Menopausal Symptoms

NCT07351006 | Recruiting

• 1 other identifier: 2025-06613-01
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Menopause Syndrome; Sleep Disturbance

Outcome Measures

Primary Outcomes (1)

• Menopause Rating Scale (MRS)

  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

Secondary Outcomes (1)

• Pittsburgh Sleep Quality Index (PSQI)

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

Study Arms (3)

Strength training

EXPERIMENTAL

Strength training intervention.

Other: Strength training

Dance-based training

EXPERIMENTAL

Dance-based training intervention.

Other: Dance-based training

Control

NO INTERVENTION

No intervention

Interventions

Dance-based training OTHER

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.

Dance-based training

Strength training OTHER

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.

Strength training

Eligibility Criteria

• Age: 45 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Linnaeus University: lead

Study Sites (1)

Sofia Ryman Augustsson

Kalmar, 391 82, Sweden

RECRUITING

MeSH Terms

Conditions

Parasomnias

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessors are blinded to the type of intervention (or control) that the participants are assigned to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomly assigned to 1) Intervention with strength training (n=15); 2) Intervention with dance-based training (n=15) or 3) control group (n=15).

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: January 20, 2026
• Study Start: November 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

SE (1)