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Clinical Trials/NCT01987778
NCT01987778
Completed
Not Applicable

Health Effects of Resistance Training on Postmenopausal Women

Ostergotland County Council, Sweden1 site in 1 country65 target enrollmentNovember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hot Flashes
Sponsor
Ostergotland County Council, Sweden
Enrollment
65
Locations
1
Primary Endpoint
Change in frequency of hot flushes per 24 h
Status
Completed
Last Updated
5 years ago

Overview

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. 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.

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.

Registry
clinicaltrials.gov
Start Date
November 2013
End Date
June 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Ostergotland County Council, Sweden
Responsible Party
Principal Investigator
Principal Investigator

Mats Hammar

MD, professor

Ostergotland County Council, Sweden

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.

Outcomes

Primary Outcomes

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

  • 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)
  • Volume of white and brown adipose tissue and muscle volume(Baseline to 15 weeks of intervention/control group)
  • Body mass index and abdominal height(Baseline to 15 weeks of intervention/control group)
  • Blood pressure(Baseline to 15 weeks of intervention/control group)
  • Severity of hot flushes(Baseline to 15 weeks of intervention/control group. Follow-up after 6 and 24 months.)

Study Sites (1)

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