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Effects of Exercise Training on Cardiovascular Health in Middle-aged Women

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ClinicalTrials.gov Identifier: NCT02135575
Recruitment Status : Completed
First Posted : May 12, 2014
Last Update Posted : August 16, 2018
Sponsor:
Collaborators:
Glostrup University Hospital, Copenhagen
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Ylva Hellsten, University of Copenhagen

Tracking Information
First Submitted Date  ICMJE April 1, 2014
First Posted Date  ICMJE May 12, 2014
Last Update Posted Date August 16, 2018
Study Start Date  ICMJE May 2014
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 2, 2015)
  • Leg vascular function [ Time Frame: Baseline comparison and changes from baseline to 3 months ]
    Measurements of leg blood flow by ultrasound doppler during exercise and during femoral arterial infusion of vasodilators
  • Cardiac structure and function [ Time Frame: Baseline comparison and changes from baseline to 3 months ]
    Magnetic resonance imaging and transthoracic echocardiography
  • Platelet function [ Time Frame: Baseline comparison and changes from baseline to 3 months ]
    Platelet aggregation assay of whole blood and platelet rich plasma
Original Primary Outcome Measures  ICMJE
 (submitted: May 6, 2014)
  • Leg vascular function [ Time Frame: Baseline comparison and changes at 3 and 10 months ]
    Measurements of leg blood flow by ultrasound doppler during exercise and during femoral arterial infusion of vasodilators
  • Cardiac structure and function [ Time Frame: Baseline comparison and changes at 3 and 10 months ]
    Magnetic resonance imaging and transthoracic echocardiography
  • Platelet function [ Time Frame: Baseline comparison and changes at 3 and 10 months ]
    Platelet aggregation assay of whole blood and platelet rich plasma
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2015)
  • Expression of proteins in muscle samples [ Time Frame: Baseline comparison and changes from baseline to 3 months ]
    Western Blot analysis of proteins of relevance for vascular function and metabolism
  • Maximal aerobic effect [ Time Frame: Baseline comparison and changes from baseline to 3 months ]
    Maximal oxygen uptake during an incremental cycle ergometry test with gas analysis
  • Genomic profile in blood samples [ Time Frame: Baseline comparison and changes from baseline to 3 months ]
    Genomic analysis of parameters for vascular and metabolic health
  • Insulin sensitivity and glycaemic control [ Time Frame: Baseline comparison and changes from baseline to 3 months ]
    Fasting plasma glucose analysis and oral glucose tolerance test
  • Arterial blood pressure [ Time Frame: Baseline comparison and changes from baseline to 3 months ]
  • Gene expression of proteins in muscle samples [ Time Frame: Baseline comparison and changes from baseline to 3 months ]
    Gene analysis of relevance for vascular and metabolic function
  • Health related parameters in blood [ Time Frame: Baseline comparison and changes from baseline to 3 months ]
    Plasma lipid status and other variables related to vascular health
Original Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2014)
  • Expression of proteins in muscle samples [ Time Frame: Baseline comparison and changes at 3 and 10 months ]
    Western Blot analysis of proteins of relevance for vascular function and metabolism
  • Maximal aerobic effect [ Time Frame: Baseline comparison and changes at 3 and 10 months ]
    Maximal oxygen uptake during an incremental cycle ergometry test with gas analysis
  • Genomic profile in blood samples [ Time Frame: Baseline comparison and changes at 3 and 10 months ]
    Genomic analysis of parameters for vascular and metabolic health
  • Insulin sensitivity and glycaemic control [ Time Frame: Base-line comparison and changes at 3 and 10 months ]
    Fasting plasma glucose analysis and oral glucose tolerance test
  • Arterial blood pressure [ Time Frame: Baseline comparison and changes at 3 and 10 months ]
  • Gene expression of proteins in muscle samples [ Time Frame: Changes from base-line to 3 and 10 months ]
    Gene analysis of relevance for vascular and metabolic function
  • Health related parameters in blood [ Time Frame: Changes from baseline to 3 and 10 months ]
    Plasma lipid status and other variables related to vascular health
Current Other Pre-specified Outcome Measures
 (submitted: November 2, 2015)
  • Anthropometry [ Time Frame: Baseline comparison and changes from baseline to 3 months ]
    Dual x-ray absorptiometry, height, weight, waist and hip circumference
  • Activity measure [ Time Frame: Baseline comparison and changes from baseline to 3 months ]
    Activity measure for one week by accelerometer
Original Other Pre-specified Outcome Measures
 (submitted: May 6, 2014)
  • Anthropometry [ Time Frame: Baseline comparison and changes at 3 and 10 months ]
    Dual x-ray absorptiometry, height, weight, waist and hip circumference
  • Activity measure [ Time Frame: Pre, 3 and 10 months ]
    Activity measure for one week by accelerometer
  • Food registration [ Time Frame: Pre, 3 and 10 months ]
    Food registration by questionnaire for 4 days in a week
 
Descriptive Information
Brief Title  ICMJE Effects of Exercise Training on Cardiovascular Health in Middle-aged Women
Official Title  ICMJE Effects of Exercise Training on Cardiovascular Health in Middle-aged Women
Brief Summary The hypothesis of the present study is that physical training can oppose detrimental changes in cardiovascular and metabolic health associated with estrogen loss after menopause.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Menopause
  • Cardiac Function Impaired
  • Cardiovascular Diseases
  • Blood Platelet Disorders
  • Metabolic Diseases
Intervention  ICMJE Behavioral: Spinning
After the baseline studies the pre and postmenopausal women will be randomized to spinning training groups and the intervention will last for 3 months. The spinning group will spin three times per week under guidance of a trained instructor. The training is heart rate monitored.
Study Arms  ICMJE
  • Experimental: Premenopausal women
    The Premenopausal women are randomized to exercise by spinning (cycle)
    Intervention: Behavioral: Spinning
  • Experimental: Postmenopausal women
    The Postmenopausal women are randomized to exercise by spinning (cycle)
    Intervention: Behavioral: Spinning
Publications * Egelund J, Jørgensen PG, Mandrup CM, Fritz-Hansen T, Stallknecht B, Bangsbo J, Nyberg M, Hellsten Y. Cardiac Adaptations to High-Intensity Aerobic Training in Premenopausal and Recent Postmenopausal Women: The Copenhagen Women Study. J Am Heart Assoc. 2017 Aug 18;6(8). pii: e005469. doi: 10.1161/JAHA.117.005469.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: August 14, 2018)
36
Original Estimated Enrollment  ICMJE
 (submitted: May 6, 2014)
120
Actual Study Completion Date  ICMJE July 2017
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Premenopausal (45-53 years) OR postmenopausal 50-57 years
  • BMI> 18.5 and <30
  • Sedentary (no regular physical activity the last 2 years)
  • Plasma measurements
  • Premenopausal: estradiol> 0.20 nmol/l, Follicle stimulating hormone < 22 IU/l and progesterone >2.5 nmol/l
  • Postmenopausal: estradiol < 0.20 nmol/l, Follicle stimulating hormone > 22 IU/l and progesterone 0.3-2.5 nmol/l

Exclusion Criteria:

  • Smoking
  • Excessive alcohol intake
  • Regular medication including hormone replacement treatment
  • Chronic disease
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 45 Years to 57 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02135575
Other Study ID Numbers  ICMJE CWS-WP2CV
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ylva Hellsten, University of Copenhagen
Study Sponsor  ICMJE University of Copenhagen
Collaborators  ICMJE
  • Glostrup University Hospital, Copenhagen
  • Rigshospitalet, Denmark
Investigators  ICMJE
Principal Investigator: Erik Richter, MD PhD University of Copenhagen
PRS Account University of Copenhagen
Verification Date August 2018

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