Health Effects of Resistance Training on Postmenopausal Women

Menopause Clinical Trial

Official title:

Health Effects of Resistance Training on Postmenopausal Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01987778
• Other study ID #: 20131105/Styrka
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: June 2020

Study information

• Verified date: February 2021
• Source: Ostergotland County Council, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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. 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. diagnostic variables (production of myokines as irisin, immunological markers) and

3. genetic variables (length of telomeres).

The control group will be offered resistance training after the intervention period.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: June 2020
• Est. primary completion date: March 2, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hot Flashes
• Menopause

Intervention

Other:
• Resistance training
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.

Locations

Country	Name	City	State
Sweden	County Council of Östergötland, Kvinnokliniken	Linköping

Sponsors (2)

Lead Sponsor	Collaborator
Ostergotland County Council, Sweden	Linkoeping University

Country where clinical trial is conducted

Sweden, 

References & Publications (11)

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. Review. — View Citation

Borga M, Virtanen KA, Romu T, Leinhard OD, Persson A, Nuutila P, Enerbäck 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. — View Citation

Craig CL, Marshall AL, Sjöström 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. — View 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.

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. Review. Update in: Cochrane Database Syst Rev. 2014;11:CD006108. — View Citation

Ivarsson T, Spetz AC, Hammar M. Physical exercise and vasomotor symptoms in postmenopausal women. Maturitas. 1998 Jun 3;29(2):139-46. — View 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.

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. — View 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, Enerbäck 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. — View 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. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	Baseline to 15 weeks of intervention/control group. Follow-up after 6 and 24 months.
Secondary	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.	Baseline to 15 weeks of intervention
Secondary	Level of physical activity	Physical activity will be evaluated using diary and the International Physical Activity Questionnaire (IPAQ).	Baseline to 15 weeks of intervention/control group. Follow-up after 6 and 24 months.
Secondary	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)	Baseline to 15 weeks of intervention/control group
Secondary	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.	Baseline to 15 weeks of intervention/control group
Secondary	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).	Baseline to 15 weeks of intervention/control group
Secondary	Body mass index and abdominal height	Weight and length (BMI) and abdominal height measured with an abdometer	Baseline to 15 weeks of intervention/control group
Secondary	Blood pressure	Using standard measure technique for blood preassure	Baseline to 15 weeks of intervention/control group
Secondary	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.	Baseline to 15 weeks of intervention/control group. Follow-up after 6 and 24 months.