Health Effects of Resistance Training on Postmenopausal Women

Study Overview
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Brief Summary
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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
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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.

Official Title
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Health Effects of Resistance Training on Postmenopausal Women

Conditions
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Hot Flashes, Menopause

Intervention / Treatment
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* Other: Resistance training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resistance training<br>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<br>* 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.<br>|
| No Intervention: Control group<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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 | 
| 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. | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Blood pressure | Using standard measure technique for blood preassure | 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. | Baseline to 15 weeks of intervention/control group. Follow-up after 6 and 24 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hot flashes, Menopause, HRQoL, Resistance training, Physical activity, Adipose tissue