Exercise as Medicine: A Non-Pharmacological Approach to Menopausal Symptoms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-55
SponsorLinnaeus University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Biological female sex
Age 45-55 years
Hot flashes or sweating
Sleep problems
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Strength training
Other interventionThe 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.
Dance-based training
Other interventionParticipants 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.
Treatment groups
45 Participants
are divided into 3 treatment groupsGroup A: Strength trainingExperimental treatment 1 intervention
Group B: Dance-based trainingExperimental treatment 1 intervention
Group C: ControlNo intervention 0 interventions
Trial outcomes
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.
Time frame
2 times: 1) Baseline: Day 1 and 2) Post intervention: week 8Secondary outcomes
1
Pittsburgh Sleep Quality Index (PSQI)
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.
Time frame
2 times: 1) Baseline: Day 1 and 2) Post intervention: week 8Sponsors and contacts
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Source ClinicalTrials.gov