NCT01987778

Brief 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. 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

  1. 1.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),
  2. 2.diagnostic variables (production of myokines as irisin, immunological markers) and
  3. 3.genetic variables (length of telomeres).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 19, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2017

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

3.3 years

First QC Date

November 13, 2013

Last Update Submit

February 23, 2021

Conditions

Keywords

Hot flashesMenopauseHRQoLResistance trainingPhysical activityAdipose tissue

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline to 15 weeks of intervention/control group

Secondary Outcomes (9)

  • Health-related quality of life (HRQoL)

    Baseline to 15 weeks of intervention/control group. Follow-up after 6 and 24 months.

  • Muscle strength

    Baseline to 15 weeks of intervention

  • Level of physical activity

    Baseline to 15 weeks of intervention/control group. Follow-up after 6 and 24 months.

  • Concentrations of adipo-myokines/inflammatory biomarkers

    Baseline to 15 weeks of intervention/control group

  • Length of telomeres

    Baseline to 15 weeks of intervention/control group

  • +4 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

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.

Resistance training

Eligibility Criteria

Age45 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

County Council of Östergötland, Kvinnokliniken

Linköping, 58185, Sweden

Location

Related Publications (14)

  • 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.

    BACKGROUND
  • 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.

    PMID: 23603813BACKGROUND
  • Borga 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.

    PMID: 24480345BACKGROUND
  • Karlsson 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
  • 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.

    PMID: 21563149BACKGROUND
  • Beavers 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.

    PMID: 20188719BACKGROUND
  • Craig 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.

    PMID: 12900694BACKGROUND
  • Ivarsson 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.

    PMID: 9651903BACKGROUND
  • Kim 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.

    PMID: 22668817BACKGROUND
  • Lindh-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.

    PMID: 15172083BACKGROUND
  • Taylor 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.

    PMID: 21820961BACKGROUND
  • Nilsson 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.

  • Nilsson 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.

  • Berin 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.

MeSH Terms

Conditions

Hot FlashesMotor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Mats L Hammar, Professor

    Linkoeping University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, professor

Study Record Dates

First Submitted

November 13, 2013

First Posted

November 19, 2013

Study Start

November 1, 2013

Primary Completion

March 2, 2017

Study Completion

June 1, 2020

Last Updated

February 24, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations