Strength and Aerobic Training Against Hot Flushes in Postmenopausal Women (NCT06030388) | Clinical Trial Compass
RecruitingNot Applicable
Strength and Aerobic Training Against Hot Flushes in Postmenopausal Women
Sweden90 participantsStarted 2023-09-12
Plain-language summary
The goal of this randomised controlled trial is to investigate the effects of and compare two modes of physical exercise (strength training and high-intensity aerobic exercise) to unchanged physical activity on vasomotor symptoms (hot flushes) in postmenopausal women. The main question it aims to answer is the effect of 15 weeks of strength training vs high intensity aerobic training vs unchanged physical activity on frequency and severity of hot flushes. Participants will be randomised to:
1. strength training
2. high-intensity aerobic training
3. untreated control group.
Researchers will compare strength training, high-intensity aerobic training and untreated control group to see if training can reduce hot flushes.
Who can participate
Age range
45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Postmenopausal women (one of: ≥ 12 months since last menstruation; amenorrhea due to intrauterine device or hysterectomy and Follicle Stimulating Hormone (FSH) \>30 mIU/ml; bilateral oophorectomy; induced menopause due to chemotherapy or radiation and ≥2 years amenorrhea);
* ≥ 28 moderate to severe hot flushes per week during a 2-week screening period, registered through a daily VMS diary;
* Age ≥45 years;
* Physical ability to participate in strength training or high intensity aerobic exercise for 60 minutes, 3 times/week during 15 weeks;
* Understand Swedish orally and in writing
Exclusion Criteria:
* Regular physical activity \>30 minutes per week of vigorous intensity or ≥150 minutes of moderate intensity or combined activities representing maximum 150 minutes of moderate intensity;
* Use of systemic menopausal hormone therapy the last 2 months;
* Use of natural preparations such as herbal preparations for VMS, or other medications for VMS the last 2 months;
* Capillary hemoglobin \<110 g/l;
* Blood pressure \>160 mmHg systolic or \>100 mmHg diastolic;
* Unstable medical condition with a potential to affect VMS (like unregulated thyroid disease);
* Medical condition that by a physician is judged not appropriate (because of potential to affect VMS or risk of injury with vigorous exercise)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.