Strength and Aerobic Training Against Hot Flushes in Postmenopausal Women
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45+
SponsorLinkoeping University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Strength training
Other interventionBoth 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
Other interventionBoth 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.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Strength trainingActive comparator 1 intervention
Group B: High-intensity aerobic trainingActive comparator 1 intervention
Group C: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Frequency of moderate and severe hot flushes
Frequency of hot flushes per 24 h daily recorded in hot flush diary from baseline throughout 15 weeks of intervention.
Time frame
baseline to 15 weeksSecondary outcomes
1
Frequency of moderate and severe hot flushes
Frequency of hot flushes per 24 h daily recorded in hot flush diary 2 weeks at baseline and 2 weeks at each of the time points.
Time frame
baseline to 6 months, 1, 2 and 5 years2
Severity of hot flushes
Severity of hot flushes per 24 hours recorded in hot flush diary from baseline throughout 15 weeks of intervention and two weeks during follow-up.
Time frame
baseline to 15 weeks, 6 months, 1, 2 and 5 years3
Generic health-related quality of life
Short-form 36, 36 questions in 8 scales. Scores for each domain range from 0-100, and a high score represents a higher health-related quality of life.
Time frame
baseline to 15 weeks, 6 months, 1, 2 and 5 years after intervention4
Women specific health-related quality of life
Women's health questionnaire nine sub-scales with four-point scales (yes definitely, yes sometimes, not not much, no not at all) that are reduced to binary options (0/1). The subscale items are summated and divided by the number of items in each subscale.A higher score represents worse outcome.
Time frame
baseline to 15 weeks, 6 months, 1, 2 and 5 years after interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Linkoeping University
Lead sponsor
Region Östergötland
Collaborator
Länssjukhuset i Kalmar län
Collaborator
Source ClinicalTrials.gov