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Completed

NCT Number: NCT01987778

Health Effects of Resistance Training on Postmenopausal Women

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.

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Key information

Conditions

Hot Flashes Behavior Menopause Motor Activity Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

45 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

County Council of Östergötland, Kvinnokliniken

Linköping, 58185, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Resistance training

Other

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 outcomes

  1. 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.

Secondary outcomes

  1. Health-related quality of life (HRQoL)

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

    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)

  2. Muscle strength

    Time frame: Baseline to 15 weeks of intervention

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

  3. Level of physical activity

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

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

  4. Concentrations of adipo-myokines/inflammatory biomarkers

    Time frame: Baseline to 15 weeks of intervention/control group

    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)

  5. Length of telomeres

    Time frame: Baseline to 15 weeks of intervention/control group

    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.

  6. Volume of white and brown adipose tissue and muscle volume

    Time frame: Baseline to 15 weeks of intervention/control group

    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).

  7. Body mass index and abdominal height

    Time frame: Baseline to 15 weeks of intervention/control group

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

  8. Blood pressure

    Time frame: Baseline to 15 weeks of intervention/control group

    Using standard measure technique for blood preassure

  9. Severity of hot flushes

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

    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.

Sponsors and collaborators

Lead sponsor

Ostergotland County Council, Sweden

Other

Collaborators

  • Linkoeping University

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2020
First posted
Nov 19, 2013
Registry last updated
Feb 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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