Menopause SyndromeNCT07351006
Exercise as Medicine: A Non-Pharmacological Approach to Menopausal Symptoms
A study testing Strength training and Dance-based training in people with Menopause Syndrome and Sleep Disturbance, run by Linnaeus University at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 55 years, women only
- Conditions the study is for
- Menopause Syndrome, Sleep Disturbance
- What is being tested?
- Strength training and Dance-based training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSweden
- Study dates
- 1 Nov 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 11Show fewer
- Dry mucous membranes
- Recurrent urinary tract infections or overactive bladder
- Joint pain
- Decreased libido
- Weight gain
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Sofia Ryman Augustsson
Kalmar, 391 82
Sofia Ryman Augustsson, PhD, +46480-44 63 58, sofia.rymanaugustsson@lnu.se
About this study
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:
Read more
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
Read the detailed description
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.
- Conditions
- Menopause Syndrome, Sleep Disturbance
- Being tested
- Strength training, Dance-based training
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength trainingOther
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.
Dance-based trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Strength training | Experimental | Strength training intervention. Receives: Other: Strength training |
| Dance-based training | Experimental | Dance-based training intervention. Receives: Other: Dance-based training |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 times: 1) Baseline: Day 1 and 2) Post intervention: week 8
Secondary 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.
Measured: 2 times: 1) Baseline: Day 1 and 2) Post intervention: week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Nov 2025
- Primary completionMay 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopause SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linnaeus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sofia Ryman Ryman Augustsson, Linnaeus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07351006
- Sponsor's protocol ID
- 2025-06613-01
- Other IDs
- 2025
- Status last verified
- Sep 2026
- First submitted
- 16 Dec 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise as Medicine: A Non-Pharmacological Approach to Menopausal Symptoms
- ClinicalTrials.gov ID
- NCT07351006
- Acronym / sponsor ID
- 2025-06613-01
- Conditions
- Menopause Syndrome, Sleep Disturbance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Linnaeus UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Strength training | Experimental | Other: Strength trainingStrength training intervention. |
| Dance-based training | Experimental | Other: Dance-based trainingDance-based training intervention. |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strength trainingThe 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. | Other | Strength training |
| Dance-based trainingParticipants 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. | Other | Dance-based training |
Primary outcome
Menopause Rating Scale (MRS)
Time frame: 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.
1 secondary outcome
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 2 times: 1) Baseline: Day 1 and 2) Post intervention: week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength training and Dance-based training in people with Menopause Syndrome and Sleep Disturbance, run by Linnaeus University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menopause Rating Scale (MRS) (time frame: 2 times: 1) Baseline: Day 1 and 2) Post intervention: week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.