Strength and Aerobic Training Against Hot Flushes in Postmenopausal Women

NCT06030388 · tracked via the Priya Life Science Sweden tracker

Sponsor

Linkoeping University

Phase

Not applicable

Started

2023-09-12

Last updated

2025-01-22

Condition(s) studied

Postmenopausal SymptomsHot Flashes

Investigational drug(s) / intervention(s)

Strength trainingHigh-intensity aerobic training

Strength training: Both interventions (strength training and high intensity aerobic training) will be introduced with a 3-week adaptation period with lower loads (strength training) or intensity (aerobic training) followed by a 12-week period on the intended load/intensity. All participants in the intervention groups will be recommended to exercise three times per week (one hour per session) and in addition be active with everyday low-intensity physical activity. A structured and detailed training diary will be used in both groups to register frequency of each training session, as well as everyday physical activity. For the strength training, load and dose will also be registered for each training session.

High-intensity aerobic training: Both interventions (strength training and high intensity aerobic training) will be introduced with a 3-week adaptation period with lower loads (strength training) or intensity (aerobic training) followed by a 12-week period on the intended load/intensity. All participants in the intervention groups will be recommended to exercise three times per week (one hour per session) and in addition be active with everyday low-intensity physical activity. A structured and detailed training diary will be used in both groups to register frequency of each training session, as well as everyday physical activity. For the strength training, load and dose will also be registered for each training session.

Study 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

Sex

FEMALE

Min age

45 Years

Max age

—

Healthy volunteers

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)

Primary outcome measure(s)

Frequency of moderate and severe hot flushes — baseline to 15 weeks
Frequency of hot flushes per 24 h daily recorded in hot flush diary from baseline throughout 15 weeks of intervention.

Trial sites (2)

Facility	City	Region	Status
Region Kalmar Län	Kalmar	Sweden	Recruiting
Region Östergötland	Linköping	Sweden	Recruiting