Exercise to Reduce Hot Flushes in Postmenopausal Women

STrength and AeRobic Training Against Vasomotor Symptoms (START) in Postmenopausal Women

This study is testing whether strength training or high-intensity aerobic exercise can help reduce hot flushes in postmenopausal women.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 45 Years and up
• Sex: Female
• Sponsor: Linkoeping University (Government)
• Drugs / interventions: chemotherapy, radiation
• Locations: 2 sites (Kalmar and 1 other locations)
• Trial ID: NCT06030388 on ClinicalTrials.gov

What this trial studies

This randomized controlled trial aims to compare the effects of strength training and high-intensity aerobic exercise on hot flushes in postmenopausal women. Participants will be assigned to one of three groups: strength training, high-intensity aerobic training, or an untreated control group. The study will assess the frequency and severity of vasomotor symptoms over 15 weeks, along with secondary outcomes such as quality of life and sleep quality. The goal is to identify effective, evidence-based exercise interventions for managing postmenopausal symptoms.

Who should consider this trial

Good fit: Ideal candidates are postmenopausal women aged 45 and older experiencing moderate to severe hot flushes.

Not a fit: Patients who are regularly active with vigorous exercise or those using hormone therapy or natural preparations for hot flushes may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide effective non-pharmacological treatment options for managing hot flushes in postmenopausal women.

How similar studies have performed: Previous studies have shown that exercise can positively impact menopausal symptoms, suggesting potential success for this approach.

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)

Where this trial is running

Kalmar and 1 other locations

• Region Kalmar Län — Kalmar, Sweden (Recruiting)
• Region Östergötland — Linköping, Sweden (Recruiting)

Study contacts

• Principal investigator: Anna-Clara Spetz Holm, Ass prof, MD — Region Östergötland, Linköping university
• Study coordinator: Anna-Clara Spetz Holm, Ass prof, MD

Conditions Postmenopausal Symptoms; Hot Flashes; aerobic training; strength training