Hot FlashesNCT01987778
Health Effects of Resistance Training on Postmenopausal Women
A study testing Resistance training in people with Hot Flashes and Menopause, run by Ostergotland County Council, Sweden at 1 site in Sweden.
Trial summary
Today's women will live more than a third of their lives after menopause, i.e. with a changed hormonal and metabolic state. Vasomotor symptoms like hot flushes and sweating are reported by about 75% of all women around menopause and may impair well-being, mental state, daily activities and night sleep. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Hot Flashes, Menopause
- What is being tested?
- Resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2013to Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 who had at least 28 moderate to severe hot flashes per week during a screening period of two weeks.(Postmenopausal, i.e. had their last menstrual bleeding at least 12 months ago or have increased gonadotrophic hormones showing they are postmenopausal.)
- At lest 45 years of age
- Good physical health and physical ability to take part in organized resistance training or other training at least three times per week.
- Ability to speak and read Swedish
- Freely informed consent for participation
Who cannot join
- Physically active more than 75 minutes of intense exercise per week or more than 150 minutes of low intensity activities
- Hb <110 g/l
- Blood pressure >160 systolic and/or >100 mmHg diastolic pressure
- Ongoing usage or use during the last two months of hormone therapy aimed for hot flashes
- Treatment with psychopharmacological drugs (e.g SSRI or SNRI) or other treatment with a possible effect on menopausal symptoms
- Uninvestigated or unstable disease that could affect presence of flushes (e.g thyroid disease)
- Other medical condition that is judged inappropriate to combine with physical activity or participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Today's women will live more than a third of their lives after menopause, i.e. with a changed hormonal and metabolic state. Vasomotor symptoms like hot flushes and sweating are reported by about 75% of all women around menopause and may impair well-being, mental state, daily activities and night sleep. Vasomotor symptoms are less prevalent in women who participate in regular physical exercise. It is, however, still uncertain if physical exercise reduces vasomotor symptoms.
The purpose of this randomized controlled study is to establish possible beneficial health effects from 15 weeks of supervised resistance training (RT) on postmenopausal women. End-points include effects from RT in postmenopausal women on
Read more
- clinical outcomes (number and severity of vasomotor symptoms, Health-Related quality of Life (HRQoL), Body Mass Index (BMI), abdominal height, muscle strength and mass, browning of fat),
- diagnostic variables (production of myokines as irisin, immunological markers) and
- genetic variables (length of telomeres).
The control group will be offered resistance training after the intervention period.
Read the detailed description
The first phase is planned as a pilot-study including 20 women participating for 15 weeks. Thereafter an evaluation of the sample size and the study methodology will be made.
- Conditions
- Hot Flashes, Menopause
- Being tested
- Resistance training
- Keywords
- Hot flashes, Menopause, HRQoL, Resistance training, Physical activity, Adipose tissue
- Medical subject headings
- Hot Flashes, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance trainingOther
Resistance training supervised and individualized by an experienced physiotherapist. First the relative load will be lighter during three weeks, thereafter the intensity and load will be increased over another 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Resistance training | Experimental | The resistance training will be supervised and individualized by an experienced physiotherapist. First the relative load will be lighter during three weeks, thereafter the intensity and load will be increased over another 12 weeks. Receives: Other: Resistance training |
| Control group | No intervention | No intervention for 15 weeks but the same registrations, diaries and forms as the intervention group. The control group will however be omitted from muscle strength testing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in frequency of hot flushes per 24 h
Frequency of hot flushes per 24 h daily recorded in hot flush diary from baseline throughout 15 weeks of intervention. Comparison between intervention group and control group.
Measured: Baseline to 15 weeks of intervention/control group
Secondary outcomes (9)
Health-related quality of life (HRQoL)
HRQoL will be measured with a generic measure (Short Form Health Survey - SF-36) and a measure specifically developed for mid-aged women (Women's Health Questionnaire)
Measured: Baseline to 15 weeks of intervention/control group. Follow-up after 6 and 24 months.
Muscle strength
Muscle strength will be evaluated in the intervention group with 8 repetition maximum (8 RM) tests for the major muscles in the extremities.
Measured: Baseline to 15 weeks of intervention
Level of physical activity
Physical activity will be evaluated using diary and the International Physical Activity Questionnaire (IPAQ).
Measured: Baseline to 15 weeks of intervention/control group. Follow-up after 6 and 24 months.
Concentrations of adipo-myokines/inflammatory biomarkers
The markers to assess are as follows: Leptin, Irisin, IL-6, IL-7, IL-8, monocyte chemoattractant protein-1(MCP-1), tumor necrosis factor (TNF), IL-4, IL-10, IL-15, brain-derived neurotrophic factor (BDNF), matrix metalloproteinase (MMP)-2 and MMP-9 in blood samples shortly after a resistance-training and on a day without work-out; samples with direct measurement (plasma) and after white blood cell stimulation, conditioned medium with multiple bead technology (Luminex) and enzyme linked immunosorbent assay (ELISA)
Measured: Baseline to 15 weeks of intervention/control group
Length of telomeres
Length of telomeres will be measured in DNA isolated from blood samples with a qPCR based method. Recently, the telomere length was associated with certain SNP´s in the hTERT gene and these will also be assessed.
Measured: Baseline to 15 weeks of intervention/control group
Volume of white and brown adipose tissue and muscle volume
Using magnetic resonance imaging (MRI) the volume of total (TAT), subcutaneous (SCAT) and visceral (VAT) white adipose tissue (Dahlqvist Leinhard 2008); the concentration of lipids diffusively stored in the liver parenchyma, and the volume of intramuscular adipose tissue (IMAT) in the quadriceps muscle will be quantified. Furthermore, the MRI images will be used to quantify the volume of and fat concentration in supraclavicular and interscapular brown adipose tissue according to our recently published measurement protocol (Lidell 2013, Borga 2013), as well as the volume of the major extensor and flexor muscles (Karlsson 2013).
Measured: Baseline to 15 weeks of intervention/control group
Body mass index and abdominal height
Weight and length (BMI) and abdominal height measured with an abdometer
Measured: Baseline to 15 weeks of intervention/control group
Blood pressure
Using standard measure technique for blood preassure
Measured: Baseline to 15 weeks of intervention/control group
Severity of hot flushes
Severity of hot flushes per 24 h recorded in hot flush diary from baseline throughout 15 weeks of intervention and one week during follow-up at 6 and 24 months.
Measured: Baseline to 15 weeks of intervention/control group. Follow-up after 6 and 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2013 (estimated)
- Study startNov 2013
- Primary completion2 Mar 2017
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Hot FlashesStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ostergotland County Council, Sweden
- Sponsor type
- University, hospital or other
- Collaborators
- Linkoeping University
- Responsible party
- Principal investigator, Mats Hammar, Ostergotland County Council, Sweden
- Investigators
- Mats L Hammar, Professor, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01987778
- Sponsor's protocol ID
- 20131105/Styrka
- Status last verified
- Feb 2021
- First submitted
- 13 Nov 2013
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Dahlqvist Leinhard O, Johansson A, Rydell J, Smedby Ö, Nyström F, Lundberg P, Borga M. Quantitative Abdominal Fat Estimation Using MRI. 2008 19th International Conference on Pattern Recognition, ICPR 2008 , art. no. 4761764.
Lidell ME, Betz MJ, Dahlqvist Leinhard O, Heglind M, Elander L, Slawik M, Mussack T, Nilsson D, Romu T, Nuutila P, Virtanen KA, Beuschlein F, Persson A, Borga M, Enerback S. Evidence for two types of brown adipose tissue in humans. Nat Med. 2013 May;19(5):631-4. doi: 10.1038/nm.3017. Epub 2013 Apr 21.
PubMed 23603813Borga M, Virtanen KA, Romu T, Leinhard OD, Persson A, Nuutila P, Enerback S. Brown adipose tissue in humans: detection and functional analysis using PET (positron emission tomography), MRI (magnetic resonance imaging), and DECT (dual energy computed tomography). Methods Enzymol. 2014;537:141-59. doi: 10.1016/B978-0-12-411619-1.00008-2.
PubMed 24480345Karlsson A, Rosander J, Tallberg J, Romu T, Borga M, Dahlqvist Leinhard O. Whole Body Muscle Classification using Multiple Prototype Voting. Proceedings of the ISMRM Annual Meeting (ISMRM'13), 2013.
Daley A, Stokes-Lampard H, Macarthur C. Exercise for vasomotor menopausal symptoms. Cochrane Database Syst Rev. 2011 May 11;(5):CD006108. doi: 10.1002/14651858.CD006108.pub3.
PubMed 21563149Beavers KM, Brinkley TE, Nicklas BJ. Effect of exercise training on chronic inflammation. Clin Chim Acta. 2010 Jun 3;411(11-12):785-93. doi: 10.1016/j.cca.2010.02.069. Epub 2010 Feb 25.
PubMed 20188719Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
PubMed 12900694Ivarsson T, Spetz AC, Hammar M. Physical exercise and vasomotor symptoms in postmenopausal women. Maturitas. 1998 Jun 3;29(2):139-46. doi: 10.1016/s0378-5122(98)00004-8.
PubMed 9651903Kim JH, Ko JH, Lee DC, Lim I, Bang H. Habitual physical exercise has beneficial effects on telomere length in postmenopausal women. Menopause. 2012 Oct;19(10):1109-15. doi: 10.1097/gme.0b013e3182503e97.
PubMed 22668817Lindh-Astrand L, Nedstrand E, Wyon Y, Hammar M. Vasomotor symptoms and quality of life in previously sedentary postmenopausal women randomised to physical activity or estrogen therapy. Maturitas. 2004 Jun 15;48(2):97-105. doi: 10.1016/S0378-5122(03)00187-7.
PubMed 15172083Taylor JD, Fletcher JP. Reliability of the 8-repetition maximum test in men and women. J Sci Med Sport. 2012 Jan;15(1):69-73. doi: 10.1016/j.jsams.2011.07.002. Epub 2011 Aug 5.
PubMed 21820961Thorell S, West J, Lindblom H, Hammar M, Borga M, Spetz Holm AC. Effects of resistance training on postmenopausal women's muscle strength, muscle volume and muscle fat infiltration: A secondary analysis of a randomised controlled trial. Maturitas. 2026 Apr;207:108856. doi: 10.1016/j.maturitas.2026.108856. Epub 2026 Feb 3.
PubMed 41687563Nilsson S, Henriksson M, Hammar M, Berin E, Lawesson SS, Ward LJ, Li W, Holm AS. A 2-year follow-up to a randomized controlled trial on resistance training in postmenopausal women: vasomotor symptoms, quality of life and cardiovascular risk markers. BMC Womens Health. 2024 Sep 13;24(1):511. doi: 10.1186/s12905-024-03351-1.
PubMed 39272114Nilsson S, Hammar M, West J, Borga M, Thorell S, Spetz Holm AC. Resistance training decreased abdominal adiposity in postmenopausal women. Maturitas. 2023 Oct;176:107794. doi: 10.1016/j.maturitas.2023.107794. Epub 2023 Jul 6.
PubMed 37421844Berin E, Spetz Holm AC, Hammar M, Lindh-Astrand L, Bertero C. Postmenopausal women's experiences of a resistance training intervention against vasomotor symptoms: a qualitative study. BMC Womens Health. 2022 Jul 30;22(1):320. doi: 10.1186/s12905-022-01900-0.
PubMed 35907840
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Effects of Resistance Training on Postmenopausal Women
- ClinicalTrials.gov ID
- NCT01987778
- Acronym / sponsor ID
- 20131105/Styrka
- Conditions
- Hot Flashes, Menopause
- Keywords
- Hot flashes, Menopause, HRQoL, Resistance training, Physical activity, Adipose tissue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Ostergotland County Council, SwedenUniversity, hospital or other
- Collaborators
- Linkoeping University
- Study start
- Nov 2013 (actual)
- Primary completion
- 2 Mar 2017 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 19 Nov 2013 (estimated)
- 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.
Today's women will live more than a third of their lives after menopause, i.e. with a changed hormonal and metabolic state. Vasomotor symptoms like hot flushes and sweating are reported by about 75% of all women around menopause and may impair well-being, mental state, daily activities and night sleep. Vasomotor symptoms are less prevalent in women who participate in regular physical exercise. It is, however, still uncertain if physical exercise reduces vasomotor symptoms.
The purpose of this randomized controlled study is to establish possible beneficial health effects from 15 weeks of supervised resistance training (RT) on postmenopausal women. End-points include effects from RT in postmenopausal women on
- clinical outcomes (number and severity of vasomotor symptoms, Health-Related quality of Life (HRQoL), Body Mass Index (BMI), abdominal height, muscle strength and mass, browning of fat),
- diagnostic variables (production of myokines as irisin, immunological markers) and
- genetic variables (length of telomeres).
The control group will be offered resistance training after the intervention period.
Detailed description
The first phase is planned as a pilot-study including 20 women participating for 15 weeks. Thereafter an evaluation of the sample size and the study methodology will be made.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistance training | Experimental | Other: Resistance trainingThe resistance training will be supervised and individualized by an experienced physiotherapist. First the relative load will be lighter during three weeks, thereafter the intensity and load will be increased over another 12 weeks. |
| Control group | No intervention | –No intervention for 15 weeks but the same registrations, diaries and forms as the intervention group. The control group will however be omitted from muscle strength testing. |
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 who had at least 28 moderate to severe hot flashes per week during a screening period of two weeks.(Postmenopausal, i.e. had their last menstrual bleeding at least 12 months ago or have increased gonadotrophic hormones showing they are postmenopausal.)
- At lest 45 years of age
- Good physical health and physical ability to take part in organized resistance training or other training at least three times per week.
- Ability to speak and read Swedish
- Freely informed consent for participation
Key exclusion criteria (7 listed)
- Physically active more than 75 minutes of intense exercise per week or more than 150 minutes of low intensity activities
- Hb <110 g/l
- Blood pressure >160 systolic and/or >100 mmHg diastolic pressure
- Ongoing usage or use during the last two months of hormone therapy aimed for hot flashes
- Treatment with psychopharmacological drugs (e.g SSRI or SNRI) or other treatment with a possible effect on menopausal symptoms
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 |
|---|---|---|
| Resistance trainingResistance training supervised and individualized by an experienced physiotherapist. First the relative load will be lighter during three weeks, thereafter the intensity and load will be increased over another 12 weeks. | Other | Resistance training |
Primary outcome
Change in frequency of hot flushes per 24 h
Time frame: Baseline to 15 weeks of intervention/control group
Frequency of hot flushes per 24 h daily recorded in hot flush diary from baseline throughout 15 weeks of intervention. Comparison between intervention group and control group.
9 secondary outcomes
Health-related quality of life (HRQoL)
Time frame: Baseline to 15 weeks of intervention/control group. Follow-up after 6 and 24 months.
Muscle strength
Time frame: Baseline to 15 weeks of intervention
Level of physical activity
Time frame: Baseline to 15 weeks of intervention/control group. Follow-up after 6 and 24 months.
Concentrations of adipo-myokines/inflammatory biomarkers
Time frame: Baseline to 15 weeks of intervention/control group
Length of telomeres
Time frame: Baseline to 15 weeks of intervention/control group
Volume of white and brown adipose tissue and muscle volume
Time frame: Baseline to 15 weeks of intervention/control group
Body mass index and abdominal height
Time frame: Baseline to 15 weeks of intervention/control group
Blood pressure
Time frame: Baseline to 15 weeks of intervention/control group
Severity of hot flushes
Time frame: Baseline to 15 weeks of intervention/control group. Follow-up after 6 and 24 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- BackgroundDahlqvist Leinhard O, Johansson A, Rydell J, Smedby Ö, Nyström F, Lundberg P, Borga M. Quantitative Abdominal Fat Estimation Using MRI. 2008 19th International Conference on Pattern Recognition, ICPR 2008 , art. no. 4761764.
- Background: PubMed 23603813Lidell ME, Betz MJ, Dahlqvist Leinhard O, Heglind M, Elander L, Slawik M, Mussack T, Nilsson D, Romu T, Nuutila P, Virtanen KA, Beuschlein F, Persson A, Borga M, Enerback S. Evidence for two types of brown adipose tissue in humans. Nat Med. 2013 May;19(5):631-4. doi: 10.1038/nm.3017. Epub 2013 Apr 21.
- Background: PubMed 24480345Borga M, Virtanen KA, Romu T, Leinhard OD, Persson A, Nuutila P, Enerback S. Brown adipose tissue in humans: detection and functional analysis using PET (positron emission tomography), MRI (magnetic resonance imaging), and DECT (dual energy computed tomography). Methods Enzymol. 2014;537:141-59. doi: 10.1016/B978-0-12-411619-1.00008-2.
- BackgroundKarlsson A, Rosander J, Tallberg J, Romu T, Borga M, Dahlqvist Leinhard O. Whole Body Muscle Classification using Multiple Prototype Voting. Proceedings of the ISMRM Annual Meeting (ISMRM'13), 2013.
- Background: PubMed 21563149Daley A, Stokes-Lampard H, Macarthur C. Exercise for vasomotor menopausal symptoms. Cochrane Database Syst Rev. 2011 May 11;(5):CD006108. doi: 10.1002/14651858.CD006108.pub3.
- Background: PubMed 20188719Beavers KM, Brinkley TE, Nicklas BJ. Effect of exercise training on chronic inflammation. Clin Chim Acta. 2010 Jun 3;411(11-12):785-93. doi: 10.1016/j.cca.2010.02.069. Epub 2010 Feb 25.
- Background: PubMed 12900694Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
- Background: PubMed 9651903Ivarsson T, Spetz AC, Hammar M. Physical exercise and vasomotor symptoms in postmenopausal women. Maturitas. 1998 Jun 3;29(2):139-46. doi: 10.1016/s0378-5122(98)00004-8.
- Background: PubMed 22668817Kim JH, Ko JH, Lee DC, Lim I, Bang H. Habitual physical exercise has beneficial effects on telomere length in postmenopausal women. Menopause. 2012 Oct;19(10):1109-15. doi: 10.1097/gme.0b013e3182503e97.
- Background: PubMed 15172083Lindh-Astrand L, Nedstrand E, Wyon Y, Hammar M. Vasomotor symptoms and quality of life in previously sedentary postmenopausal women randomised to physical activity or estrogen therapy. Maturitas. 2004 Jun 15;48(2):97-105. doi: 10.1016/S0378-5122(03)00187-7.
- Background: PubMed 21820961Taylor JD, Fletcher JP. Reliability of the 8-repetition maximum test in men and women. J Sci Med Sport. 2012 Jan;15(1):69-73. doi: 10.1016/j.jsams.2011.07.002. Epub 2011 Aug 5.
- Derived from this study: PubMed 41687563Thorell S, West J, Lindblom H, Hammar M, Borga M, Spetz Holm AC. Effects of resistance training on postmenopausal women's muscle strength, muscle volume and muscle fat infiltration: A secondary analysis of a randomised controlled trial. Maturitas. 2026 Apr;207:108856. doi: 10.1016/j.maturitas.2026.108856. Epub 2026 Feb 3.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Mats L Hammar, Professor principal investigator
Linkoeping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance training in people with Hot Flashes and Menopause, run by Ostergotland County Council, Sweden at 1 site 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: finished, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in frequency of hot flushes per 24 h (time frame: Baseline to 15 weeks of intervention/control group). 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 NCT01987778, which also lists 15 linked publications.
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 24 Feb 2021.