Postmenopausal SymptomsSTARTNCT06030388
Strength and Aerobic Training Against Hot Flushes in Postmenopausal Women
A study testing Strength training and High-intensity aerobic training in people with Postmenopausal Symptoms and Hot Flashes, run by Linkoeping University at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Postmenopausal Symptoms, Hot Flashes
- What is being tested?
- Strength training and High-intensity aerobic training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesSweden
- Study dates
- 12 Sep 2023to Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites, 2 recruiting
- Recruiting
Region Kalmar Län
Kalmar, S-39126
Micaela Sundell, MD, PhD
- Recruiting
Region Östergötland
Linköping, S-58185
Anna-Clara Spetz Holm, Ass prof, MD
About this study
Official title: STrength and AeRobic Training Against Vasomotor Symptoms (START) in Postmenopausal Women
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:
- strength training
- high-intensity aerobic training
- untreated control group.
Researchers will compare strength training, high-intensity aerobic training and untreated control group to see if training can reduce hot flushes.
Read the detailed description
The overall aim is to investigate the efficacy of and compare two modes of physical exercise (strength training and high-intensity aerobic exercise) to unchanged physical activity on vasomotor symptoms (VMS), as well as secondary outcomes such as health-related quality of life, sleep quality, physical activity levels, clinical outcomes, biomarkers, bone markers (outcome added January 2025), bone mineral density (outcome added January 2025), perceptions of and adherence to the interventions. In a longer perspective, the goal is to find evidence-based treatment options for VMS in postmenopausal women that are safe and effective, and have positive effects on health and quality of life after menopause.
Our hypothesis is that strength training and high-intensity aerobic exercise will reduce VMS in postmenopausal women and improve quality of life as well as clinical outcomes more than in a control group with unchanged physical activity. We also hypothesize that strength training and high-intensity aerobic training will have the same effect on the primary outcome (change in VMS) and that most of the changes in secondary outcomes will be superior in the high-intensity aerobic training group compared to the strength training group.
This is an open, two-centre, parallel, randomized controlled study performed according to the SPIRIT and CONSORT statements
Recruitment will take place by advertising on social media, in local newspapers and in the Women's clinics and primary care centers in Linköping and Kalmar. Women who respond to the advertisements will be contacted by a member of the research group or research nurse to receive information about the study and screen for inclusion and exclusion criteria. Women who are possibly eligible will be invited to a screening visit for further information and informed consent. At the visit, inclusion and exclusion criteria will be checked by a physician, and a clinical examination will be performed. Eligible participants will receive a VMS screening diary and invited to a second visit 2-3 weeks later where inclusion and randomization will be performed if the VMS inclusion criteria are fulfilled.
Randomization An allocation sequence using a computerized random number generator will be prepared by a statistician not involved in recruitment. Opaque sealed and sequentially numbered envelopes with group allocation will be prepared and opened in the presence of the participant upon inclusion and randomization.
Power analysis: A sample size calculation was made based on the results of our previous study on strength training for VMS (Berin et al 2019) and showed that to detect a 50% difference in moderate and severe hot flushes with 80% power and expected dropout rate of 20% 40 participants in total would be needed. For this three-armed set-up we estimate that 20 participants in each group will be needed, i.e. 60 in total. To also achieve sufficient power for some of the secondary outcomes the intended sample size is increased to 30 per group, 90 in total.
Data analysis: The primary analysis will be performed according to the intention-to-treat principle, including all participants who provided more than baseline data for the primary outcome. For quantitative interval data mixed design ANOVAs will be used to analyze the effect over time between and within groups. For the between-group comparisons effect sizes will be calculated. For ordinal data, such as the questionnaires, Kruskal-Wallis and Friedman test will be used for statistical analysis of the effect. Participants who complete two or more training sessions per week will be considered adherent with their assigned intervention and included in a per-protocol analysis. Detailed description of adherence, such as the fidelity with the training interventions, will be presented descriptively.
- Conditions
- Postmenopausal Symptoms, Hot Flashes
- Being tested
- Strength training, High-intensity aerobic training
- Keywords
- aerobic training, strength training
- Medical subject headings
- Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength trainingOther
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 trainingOther
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 group | Role | What they receive |
|---|---|---|
| Strength training | Active comparator | Standardised programme with the following exercises: chest press, leg press, row, leg curl, latissimus dorsi pull down and leg extension in seated resistance machines. Training will be preceded by 7-10 minutes of warm-up and followed by two body-weight exercises for the abdominal and back muscles for two sets as many repetitions as possible, and thereafter cool down and stretches. The set-up of each machine will be recorded in the training diary.
Weeks 1-3 will include two sets of training with 15-20 repetition-maximum (RM) and weeks 4-15 two sets with 8-12 RM. Throughout the intervention, loads will be adjusted to achieve muscle fatigue and approach training to failure during each set with the intent to maximize beta-endorphin release. Receives: Other: Strength training |
| High-intensity aerobic training | Active comparator | Participants will be recommended to attend spinning classes three times per week. During their first visit to the training venue, they will meet a sports physiotherapist or personal trainer to be introduced to the spinning bike intervention. The intended intensity is ≥ 14 on the Borg rating of perceived exertion scale, equivalent to high intensity training (>70% of VO2max) with the aim of attaining sufficient stimulus for beta-endorphin release. During weeks 1-3 participants will attend spinning classes for beginners with lower intensity and predominantly seated cycling. They will progress to higher intensity classes with greater variation between seated and standing cycling during week 4-15. Receives: Other: High-intensity aerobic training |
| Control group | No intervention | The control group will be recommended to carry on physical activity as usual and not to change their training or dietary habits during the 15-week study period. The control group will be contacted every fourth weeks by a research nurse to follow up on their general well-being and any questions they might have about menopause. After the study period they will be offered individual advise about training from a physiotherapist or personal trainer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline to 15 weeks
Secondary outcomes (28)
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.
Measured: baseline to 6 months, 1, 2 and 5 years
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.
Measured: baseline to 15 weeks, 6 months, 1, 2 and 5 years
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.
Measured: baseline to 15 weeks, 6 months, 1, 2 and 5 years after intervention
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.
Measured: baseline to 15 weeks, 6 months, 1, 2 and 5 years after intervention
Physical activity levels
International Physical Activity Questionnaire short form, the participant describes the amount of time (minutes and hours) that is spent on different physical activities each week, the more time, the better, except for the question about the amount of time spent in sitting.
Measured: baseline to 15 weeks, 6 months, 1, 2 and 5 years after intervention
Sleep quality
Pittsburgh sleep quality index, 7 domains. For the total instrument, the lower score, the better, from 0 (best) to 21 (worst).
Measured: baseline to 15 weeks, 6 months, 1, 2 and 5 years after intervention
Diet
Bespoke questionnaire, primarily to control for changes during the intervention period. Registration of amounts or portions. Results are presented question by question descriptively.
Measured: baseline to 15 weeks, 6 months, 1, 2 and 5 years
Accomplished physical activity
Bespoke training diary
Measured: baseline to 15 weeks, 6 months, 1, 2 and 5 years after intervention
Bioimpedance
Fat mass (%) and fat-free (muscle) mass (%)
Measured: baseline to 15 weeks
Weight
kilogram (kg)
Measured: baseline to 15 weeks
Lenght
meters (m)
Measured: baseline to 15 weeks
Body mass index
kilograms/meters2 (kg/m2)
Measured: baseline to 15 weeks
Waist circumference
millimeters (mm)
Measured: baseline to 15 weeks
Systolic and diastolic blood pressure
Unit millimetre of mercury (mmHg)
Measured: baseline to 15 weeks
Hematologic and ironstatus changes
Hemoglobin full body count, Transferrin(gram/Litre), and Ferritin (microgram/Litre)
Measured: baseline to 15 weeks, and 1 year
Changes in blood-lipids
apolipoprotein A1, apolipoprotein B (gram/Litre) and total cholesterol, low-density lipoprotein, high-density lipoprotein (mmol/L) and leptin (ng/mL)
Measured: baseline to 15 weeks, and 1 year
Changes in sex hormones and gonadotrophins
Estradiol (pmol/Litre), Sex hormone bindning globulin, Testosterone (nmol/Litre), follicle-stimulating hormone, luteinizing hormone (IE/Litre)
Measured: baseline to 15 weeks, and 1 year
Changes in glucose profile
HbA1c (mmol/Litre) and fasting blood glucose (mmol/L)
Measured: baseline to 15 weeks, and 1 year
Changes in inflammatory biomarkers
high-sensitive C-reactive Protein (microgram/Litre), Brain-derived neutrophic factor, Matrix metalloproteinase-2 and -9 (ng/mL), Interleukin -4, -6, -7, -8, 10, -15, tumour necrosis factor, monocyte chemoattractant protein-1 (pg/mL)
Measured: baseline to 15 weeks, and 1 year
Changes in the lenght of telomeres in white blood cells
Telomeres (kilobase) pair
Measured: baseline to 15 weeks, and 1 year
Changes in bone markers
25-hydroxyvitamin D (25OHD) (nmol/L), Parathyroid hormone (PTH) (pmol/L), C-terminal telopeptide cross-links of collagen type I (CTX) (ng/L), Tartrate-resistant acid phosphatase isoform 5B (TRACP5B) (U/L), Type I procollagen intact N-terminal propeptide (PINP) (µg/L), Bone-specific alkaline phosphatase (BALP) (µg/L or U/L (assay dependent)), Bioactive sclerostin (pmol/L), Osteoprotegerin (OPG) (pmol/L), Free soluble receptor activator of nuclear factor κB ligand (RANKL) (pmol/L), Intact fibroblast growth factor 23 (FGF23) (pg/mL), Irisin (µg/L). Measurement added in January 2025 and data was only collected for participants entering the study from January 2025.
Measured: Baseline to 15 weeks, and 1 year
Change in body composition (DXA - dual energy x ray absorptiometry)
Fat mass, lean mass. Measurement added in January 2025 and data was only collected for participants entering the study from January 2025.
Measured: Baseline to 15 weeks
Change in bone mineral density (DXA - dual energy x ray absorptiometry)
Bone mineral density (g/area) and T-score in spine and hip. Measurement added in January 2025 and data was only collected for participants entering the study from January 2025.
Measured: Baseline to 15 weeks
Change in exercise capacity
Change in exercise capacity is primarily used as a measure of adherence and obtained through cardiopulmonary exercise testing assessing maximum oxygen uptake milliliter/kilogram/minute (ml/kg/minute) and analysed according to local clinical routines.
Measured: baseline to 15 weeks
Experiences of the interventions, facilitators and barriers
Bespoke questionnaire, only for intervention groups. Results will be presented descriptively question by question.
Measured: baseline to 15 weeks
Adherence to the interventions
Assessed through bespoke training diary where each training session is registered and the total number of training sessions as well as training sessions/week will be calculated.
Measured: baseline to 15 weeks
Muscle strength
For strength training group only, measured using 8 repetition-maximum tests.
Measured: baseline to 15 weeks
Adverse events
Adverse events of taking part in the study
Measured: baseline to 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start12 Sep 2023
- Primary completionJun 2027 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal SymptomsStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-armed randomised trial where participants are randomised to 1) strength training, 2) high-intensity aerobic training or 3) untreated control group.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- Region Östergötland, Länssjukhuset i Kalmar län
- Responsible party
- Principal investigator, Anna-Clara Spetz Holm, Linkoeping University
- Investigators
- Anna-Clara Spetz Holm, Ass prof, MD, Principal investigator, Region Östergötland, Linköping university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06030388
- Sponsor's protocol ID
- START2022-05030-1
- Acronym
- START
- Status last verified
- Jan 2025
- First submitted
- 15 Jun 2023
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie results in publications may be available upon reasonable request to the principal investigator
Publications
Berin E, Hammar M, Lindblom H, Lindh-Astrand L, Ruber M, Spetz Holm AC. Resistance training for hot flushes in postmenopausal women: A randomised controlled trial. Maturitas. 2019 Aug;126:55-60. doi: 10.1016/j.maturitas.2019.05.005. Epub 2019 May 14.
PubMed 31239119
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STrength and AeRobic Training Against Vasomotor Symptoms (START) in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT06030388
- Acronym / sponsor ID
- START / START2022-05030-1
- Conditions
- Postmenopausal Symptoms, Hot Flashes
- Keywords
- aerobic training, strength training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- Region Östergötland, Länssjukhuset i Kalmar län
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 11 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- strength training
- high-intensity aerobic training
- untreated control group.
Researchers will compare strength training, high-intensity aerobic training and untreated control group to see if training can reduce hot flushes.
Detailed description
The overall aim is to investigate the efficacy of and compare two modes of physical exercise (strength training and high-intensity aerobic exercise) to unchanged physical activity on vasomotor symptoms (VMS), as well as secondary outcomes such as health-related quality of life, sleep quality, physical activity levels, clinical outcomes, biomarkers, bone markers (outcome added January 2025), bone mineral density (outcome added January 2025), perceptions of and adherence to the interventions. In a longer perspective, the goal is to find evidence-based treatment options for VMS in postmenopausal women that are safe and effective, and have positive effects on health and quality of life after menopause.
Our hypothesis is that strength training and high-intensity aerobic exercise will reduce VMS in postmenopausal women and improve quality of life as well as clinical outcomes more than in a control group with unchanged physical activity. We also hypothesize that strength training and high-intensity aerobic training will have the same effect on the primary outcome (change in VMS) and that most of the changes in secondary outcomes will be superior in the high-intensity aerobic training group compared to the strength training group.
This is an open, two-centre, parallel, randomized controlled study performed according to the SPIRIT and CONSORT statements
Recruitment will take place by advertising on social media, in local newspapers and in the Women's clinics and primary care centers in Linköping and Kalmar. Women who respond to the advertisements will be contacted by a member of the research group or research nurse to receive information about the study and screen for inclusion and exclusion criteria. Women who are possibly eligible will be invited to a screening visit for further information and informed consent. At the visit, inclusion and exclusion criteria will be checked by a physician, and a clinical examination will be performed. Eligible participants will receive a VMS screening diary and invited to a second visit 2-3 weeks later where inclusion and randomization will be performed if the VMS inclusion criteria are fulfilled.
Randomization An allocation sequence using a computerized random number generator will be prepared by a statistician not involved in recruitment. Opaque sealed and sequentially numbered envelopes with group allocation will be prepared and opened in the presence of the participant upon inclusion and randomization.
Power analysis: A sample size calculation was made based on the results of our previous study on strength training for VMS (Berin et al 2019) and showed that to detect a 50% difference in moderate and severe hot flushes with 80% power and expected dropout rate of 20% 40 participants in total would be needed. For this three-armed set-up we estimate that 20 participants in each group will be needed, i.e. 60 in total. To also achieve sufficient power for some of the secondary outcomes the intended sample size is increased to 30 per group, 90 in total.
Data analysis: The primary analysis will be performed according to the intention-to-treat principle, including all participants who provided more than baseline data for the primary outcome. For quantitative interval data mixed design ANOVAs will be used to analyze the effect over time between and within groups. For the between-group comparisons effect sizes will be calculated. For ordinal data, such as the questionnaires, Kruskal-Wallis and Friedman test will be used for statistical analysis of the effect. Participants who complete two or more training sessions per week will be considered adherent with their assigned intervention and included in a per-protocol analysis. Detailed description of adherence, such as the fidelity with the training interventions, will be presented descriptively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three-armed randomised trial where participants are randomised to 1) strength training, 2) high-intensity aerobic training or 3) untreated control group.
| Arm | Type | Receives |
|---|---|---|
| Strength training | Active comparator | Other: Strength trainingStandardised programme with the following exercises: chest press, leg press, row, leg curl, latissimus dorsi pull down and leg extension in seated resistance machines. Training will be preceded by 7-10 minutes of warm-up and followed by two body-weight exercises for the abdominal and back muscles for two sets as many repetitions as possible, and thereafter cool down and stretches. The set-up of each machine will be recorded in the training diary. Weeks 1-3 will include two sets of training with 15-20 repetition-maximum (RM) and weeks 4-15 two sets with 8-12 RM. Throughout the intervention, loads will be adjusted to achieve muscle fatigue and approach training to failure during each set with the intent to maximize beta-endorphin release. |
| High-intensity aerobic training | Active comparator | Other: High-intensity aerobic trainingParticipants will be recommended to attend spinning classes three times per week. During their first visit to the training venue, they will meet a sports physiotherapist or personal trainer to be introduced to the spinning bike intervention. The intended intensity is ≥ 14 on the Borg rating of perceived exertion scale, equivalent to high intensity training (>70% of VO2max) with the aim of attaining sufficient stimulus for beta-endorphin release. During weeks 1-3 participants will attend spinning classes for beginners with lower intensity and predominantly seated cycling. They will progress to higher intensity classes with greater variation between seated and standing cycling during week 4-15. |
| Control group | No intervention | –The control group will be recommended to carry on physical activity as usual and not to change their training or dietary habits during the 15-week study period. The control group will be contacted every fourth weeks by a research nurse to follow up on their general well-being and any questions they might have about menopause. After the study period they will be offered individual advise about training from a physiotherapist or personal trainer. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strength trainingBoth 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. | Other | Strength training |
| High-intensity aerobic trainingBoth 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. | Other | High-intensity aerobic training |
Primary outcome
Frequency of moderate and severe hot flushes
Time frame: baseline to 15 weeks
Frequency of hot flushes per 24 h daily recorded in hot flush diary from baseline throughout 15 weeks of intervention.
28 secondary outcomes
Frequency of moderate and severe hot flushes
Time frame: baseline to 6 months, 1, 2 and 5 years
Severity of hot flushes
Time frame: baseline to 15 weeks, 6 months, 1, 2 and 5 years
Generic health-related quality of life
Time frame: baseline to 15 weeks, 6 months, 1, 2 and 5 years after intervention
Women specific health-related quality of life
Time frame: baseline to 15 weeks, 6 months, 1, 2 and 5 years after intervention
Physical activity levels
Time frame: baseline to 15 weeks, 6 months, 1, 2 and 5 years after intervention
Sleep quality
Time frame: baseline to 15 weeks, 6 months, 1, 2 and 5 years after intervention
Diet
Time frame: baseline to 15 weeks, 6 months, 1, 2 and 5 years
Accomplished physical activity
Time frame: baseline to 15 weeks, 6 months, 1, 2 and 5 years after intervention
Bioimpedance
Time frame: baseline to 15 weeks
Weight
Time frame: baseline to 15 weeks
Lenght
Time frame: baseline to 15 weeks
Body mass index
Time frame: baseline to 15 weeks
Waist circumference
Time frame: baseline to 15 weeks
Systolic and diastolic blood pressure
Time frame: baseline to 15 weeks
Hematologic and ironstatus changes
Time frame: baseline to 15 weeks, and 1 year
Changes in blood-lipids
Time frame: baseline to 15 weeks, and 1 year
Changes in sex hormones and gonadotrophins
Time frame: baseline to 15 weeks, and 1 year
Changes in glucose profile
Time frame: baseline to 15 weeks, and 1 year
Changes in inflammatory biomarkers
Time frame: baseline to 15 weeks, and 1 year
Changes in the lenght of telomeres in white blood cells
Time frame: baseline to 15 weeks, and 1 year
Changes in bone markers
Time frame: Baseline to 15 weeks, and 1 year
Change in body composition (DXA - dual energy x ray absorptiometry)
Time frame: Baseline to 15 weeks
Change in bone mineral density (DXA - dual energy x ray absorptiometry)
Time frame: Baseline to 15 weeks
Change in exercise capacity
Time frame: baseline to 15 weeks
Experiences of the interventions, facilitators and barriers
Time frame: baseline to 15 weeks
Adherence to the interventions
Time frame: baseline to 15 weeks
Muscle strength
Time frame: baseline to 15 weeks
Adverse events
Time frame: baseline to 15 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Results publication: PubMed 31239119Berin E, Hammar M, Lindblom H, Lindh-Astrand L, Ruber M, Spetz Holm AC. Resistance training for hot flushes in postmenopausal women: A randomised controlled trial. Maturitas. 2019 Aug;126:55-60. doi: 10.1016/j.maturitas.2019.05.005. Epub 2019 May 14.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie results in publications may be available upon reasonable request to the principal investigator
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Recruiting
The Impact of Overnight Active Temperature Regulation on the Gut Microbiome, Inflammation, and Circadian Rhythm.
Poor Sleep Quality, Gut Microbiome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna-Clara Spetz Holm, Ass prof, MD principal investigator
Region Östergötland, Linköping university
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength training and High-intensity aerobic training in people with Postmenopausal Symptoms and Hot Flashes, run by Linkoeping University at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna-Clara Spetz Holm, Ass prof, MD (+46101033130, anna-clara.spetz.holm@liu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of moderate and severe hot flushes (time frame: baseline to 15 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06030388, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.