Health Effects of Resistance Training on Postmenopausal Women

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Ostergotland County Council, Sweden
Sponsor:
Collaborator:
Linkoeping University
Information provided by (Responsible Party):
Mats Hammar, Ostergotland County Council, Sweden
ClinicalTrials.gov Identifier:
NCT01987778
First received: November 13, 2013
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Hot Flashes
Menopause
Other: Resistance training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Health Effects of Resistance Training on Postmenopausal Women

Resource links provided by NLM:


Further study details as provided by Ostergotland County Council, Sweden:

Primary Outcome Measures:
  • Change in frequency of hot flushes per 24 h [ Time Frame: Baseline to 15 weeks of intervention/control group ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline to 15 weeks of intervention/control group. Follow-up after 6 and 24 months. ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 15 weeks of intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 15 weeks of intervention/control group. Follow-up after 6 and 24 months. ] [ Designated as safety issue: No ]
    Physical activity will be evaluated using diary and the International Physical Activity Questionnaire (IPAQ).

  • Concentrations of adipo-myokines/inflammatory biomarkers [ Time Frame: Baseline to 15 weeks of intervention/control group ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 15 weeks of intervention/control group ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 15 weeks of intervention/control group ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to 15 weeks of intervention/control group ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: Baseline to 15 weeks of intervention/control group ] [ Designated as safety issue: No ]
  • Severity of hot flushes [ Time Frame: Baseline to 15 weeks of intervention/control group. Follow-up after 6 and 24 months. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 80
Study Start Date: November 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Resistance training
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
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.
No Intervention: Control group
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.

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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01987778

Contacts
Contact: Mats L Hammar, Professor 0046 10 103 31 31 mats.hammar@liu.se
Contact: Lotta E Lindh-Åstrand, RN, PhD 0046 10 103 35 55 lotta.lind.astrand@lio.se

Locations
Sweden
County Council of Östergötland, Kvinnokliniken Recruiting
Linköping, Sweden, 58185
Contact: Mats L Hammar, MD    0046 101 31 683    mats.hammar@liu.se   
Contact: Lotta E Lindh-Åstrand, RN, PhD    0046 10 103 35 55    lotta.lind.astrand@lio.se   
Principal Investigator: Mats L Hammar, Professor         
Sub-Investigator: Anna-Clara Spetz Holm, MD, Phd         
Sub-Investigator: Lotta E Lindh-Åstrand, RN, PhD         
Sub-Investigator: Hanna Lindblom, RPT, MSc         
Sub-Investigator: Heriberto Rodriguez-Martinez, Professor         
Sub-Investigator: Peter Söderkvist, Professor         
Sub-Investigator: Magnus Borga, Professor         
Sub-Investigator: Olof Dahlqvist Leinhard, PhD         
Sub-Investigator: Pontus Boström, Ass prof         
Sponsors and Collaborators
Ostergotland County Council, Sweden
Linkoeping University
Investigators
Principal Investigator: Mats L Hammar, Professor Linkoeping University
  More Information

Publications:

Responsible Party: Mats Hammar, MD, professor, Ostergotland County Council, Sweden
ClinicalTrials.gov Identifier: NCT01987778     History of Changes
Other Study ID Numbers: 20131105/Styrka
Study First Received: November 13, 2013
Last Updated: February 5, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Ostergotland County Council, Sweden:
Hot flashes
Menopause
HRQoL
Resistance training
Physical activity
Adipose tissue

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014