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Health Effects of Resistance Training on Postmenopausal Women

Primary Purpose

Hot Flashes, Menopause

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Resistance training

About this trial

This is an interventional treatment trial for Hot Flashes focused on measuring Hot flashes, Menopause, HRQoL, Resistance training, Physical activity, Adipose tissue

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

County Council of Östergötland, Kvinnokliniken

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Resistance training

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

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.

Level of physical activity

Physical activity will be evaluated using diary and the International Physical Activity Questionnaire (IPAQ).

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)

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.

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).

Body mass index and abdominal height

Weight and length (BMI) and abdominal height measured with an abdometer

Blood pressure

Using standard measure technique for blood preassure

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.

Full Information

NCT ID

NCT01987778

First Posted

November 13, 2013

Last Updated

February 23, 2021

Sponsor

Ostergotland County Council, Sweden

Collaborators

Linkoeping University

1. Study Identification

Unique Protocol Identification Number

NCT01987778

Brief Title

Health Effects of Resistance Training on Postmenopausal Women

Official Title

Health Effects of Resistance Training on Postmenopausal Women

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

November 2013 (Actual)

Primary Completion Date

March 2, 2017 (Actual)

Study Completion Date

June 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ostergotland County Council, Sweden

Collaborators

Linkoeping University

4. Oversight

Data Monitoring Committee

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hot Flashes, Menopause

Keywords

Hot flashes, Menopause, HRQoL, Resistance training, Physical activity, Adipose tissue

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

65 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Resistance training

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

No Intervention

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Resistance training

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in frequency of hot flushes per 24 h

Description

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.

Time Frame

Baseline to 15 weeks of intervention/control group

Secondary Outcome Measure Information:

Title

Health-related quality of life (HRQoL)

Description

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)

Time Frame

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

Title

Muscle strength

Description

Muscle strength will be evaluated in the intervention group with 8 repetition maximum (8 RM) tests for the major muscles in the extremities.

Time Frame

Baseline to 15 weeks of intervention

Title

Level of physical activity

Description

Physical activity will be evaluated using diary and the International Physical Activity Questionnaire (IPAQ).

Time Frame

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

Title

Concentrations of adipo-myokines/inflammatory biomarkers

Description

Time Frame

Baseline to 15 weeks of intervention/control group

Title

Length of telomeres

Description

Time Frame

Baseline to 15 weeks of intervention/control group

Title

Volume of white and brown adipose tissue and muscle volume

Description

Time Frame

Baseline to 15 weeks of intervention/control group

Title

Body mass index and abdominal height

Description

Weight and length (BMI) and abdominal height measured with an abdometer

Time Frame

Baseline to 15 weeks of intervention/control group

Title

Blood pressure

Description

Using standard measure technique for blood preassure

Time Frame

Baseline to 15 weeks of intervention/control group

Title

Severity of hot flushes

Description

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.

Time Frame

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mats L Hammar, Professor

Organizational Affiliation

Linkoeping University

Official's Role

Principal Investigator

Facility Information:

Facility Name

County Council of Östergötland, Kvinnokliniken

City

Linköping

ZIP/Postal Code

58185

Country

Sweden

12. IPD Sharing Statement

Plan to Share IPD

Citations:

Citation

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.

Results Reference

background

PubMed Identifier

23603813

Citation

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.

Results Reference

background

PubMed Identifier

24480345

Citation

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.

Results Reference

background

Citation

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.

Results Reference

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PubMed Identifier

21563149

Citation

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.

Results Reference

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PubMed Identifier

20188719

Citation

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.

Results Reference

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PubMed Identifier

12900694

Citation

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.

Results Reference

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PubMed Identifier

9651903

Citation

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.

Results Reference

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PubMed Identifier

22668817

Citation

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.

Results Reference

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PubMed Identifier

15172083

Citation

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.

Results Reference

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PubMed Identifier

21820961

Citation

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.

Results Reference

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PubMed Identifier

35907840

Citation

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.

Results Reference

derived

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Health Effects of Resistance Training on Postmenopausal Women

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