Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Health Effects of Resistance Training on Postmenopausal Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01987778
Recruitment Status : Unknown
Verified April 2018 by Mats Hammar, Ostergotland County Council, Sweden.
Recruitment status was:  Active, not recruiting
First Posted : November 19, 2013
Last Update Posted : April 10, 2018
Sponsor:
Collaborator:
Linkoeping University
Information provided by (Responsible Party):
Mats Hammar, Ostergotland County Council, Sweden

Tracking Information
First Submitted Date  ICMJE November 13, 2013
First Posted Date  ICMJE November 19, 2013
Last Update Posted Date April 10, 2018
Actual Study Start Date  ICMJE November 2013
Actual Primary Completion Date March 2, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2017)
  • 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)
  • 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.
  • 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).
  • 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)
  • 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.
  • 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).
  • 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
  • Blood pressure [ Time Frame: Baseline to 15 weeks of intervention/control group ]
    Using standard measure technique for blood preassure
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2013)
  • 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)
  • 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.
  • 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).
  • 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)
  • 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.
  • 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).
  • Body mass index and abdominal height [ Time Frame: Baseline to 15 weeks of intervention/control group ]
  • Blood pressure [ Time Frame: Baseline to 15 weeks of intervention/control group ]
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Health Effects of Resistance Training on Postmenopausal Women
Official Title  ICMJE Health Effects of Resistance Training on Postmenopausal Women
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hot Flashes
  • Menopause
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Resistance training
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 13, 2013)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2019
Actual Primary Completion Date March 2, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01987778
Other Study ID Numbers  ICMJE 20131105/Styrka
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mats Hammar, Ostergotland County Council, Sweden
Study Sponsor  ICMJE Ostergotland County Council, Sweden
Collaborators  ICMJE Linkoeping University
Investigators  ICMJE
Principal Investigator: Mats L Hammar, Professor Linkoeping University
PRS Account Ostergotland County Council, Sweden
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP