NCT06030388 Strength and Aerobic Training Against Hot Flushes in Postmenopausal Women
| NCT ID | NCT06030388 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Linkoeping University |
| Condition | Postmenopausal Symptoms |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2023-09-12 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2023-09-12 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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)
Contact & Investigator
Anna-Clara Spetz Holm, Ass prof, MD
PRINCIPAL INVESTIGATOR
Region Östergötland, Linköping university
Frequently Asked Questions
Who can join the NCT06030388 clinical trial?
This trial is open to female participants only, aged 45 Years or older, studying Postmenopausal Symptoms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06030388 currently recruiting?
Yes, NCT06030388 is actively recruiting participants. Contact the research team at anna-clara.spetz.holm@liu.se for enrollment information.
Where is the NCT06030388 trial being conducted?
This trial is being conducted at Kalmar, Sweden, Linköping, Sweden.
Who is sponsoring the NCT06030388 clinical trial?
NCT06030388 is sponsored by Linkoeping University. The principal investigator is Anna-Clara Spetz Holm, Ass prof, MD at Region Östergötland, Linköping university. The trial plans to enroll 90 participants.