ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Exercise Training on Cardiovascular Health in Middle-aged 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: NCT02135575
Recruitment Status : Completed
First Posted : May 12, 2014
Last Update Posted : May 25, 2018
Sponsor:
Collaborators:
Glostrup University Hospital, Copenhagen
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Ylva Hellsten, University of Copenhagen

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.

Condition or disease Intervention/treatment Phase
Menopause Cardiac Function Impaired Cardiovascular Diseases Blood Platelet Disorders Metabolic Diseases Behavioral: Spinning Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of Exercise Training on Cardiovascular Health in Middle-aged Women
Study Start Date : May 2014
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Premenopausal women
The Premenopausal women are randomized to exercise by spinning (cycle)
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.

Experimental: Postmenopausal women
The Postmenopausal women are randomized to exercise by spinning (cycle)
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.




Primary Outcome Measures :
  1. 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

  2. Cardiac structure and function [ Time Frame: Baseline comparison and changes from baseline to 3 months ]
    Magnetic resonance imaging and transthoracic echocardiography

  3. Platelet function [ Time Frame: Baseline comparison and changes from baseline to 3 months ]
    Platelet aggregation assay of whole blood and platelet rich plasma


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. Arterial blood pressure [ Time Frame: Baseline comparison and changes from baseline to 3 months ]
  6. 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

  7. 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


Other Outcome Measures:
  1. Anthropometry [ Time Frame: Baseline comparison and changes from baseline to 3 months ]
    Dual x-ray absorptiometry, height, weight, waist and hip circumference

  2. Activity measure [ Time Frame: Baseline comparison and changes from baseline to 3 months ]
    Activity measure for one week by accelerometer



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   45 Years to 57 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02135575


Locations
Denmark
University of Copenhagen
Copenhagen, Denmark
Sponsors and Collaborators
University of Copenhagen
Glostrup University Hospital, Copenhagen
Rigshospitalet, Denmark
Investigators
Principal Investigator: Erik Richter, MD PhD University of Copenhagen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ylva Hellsten, Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT02135575     History of Changes
Other Study ID Numbers: CWS-WP2CV
First Posted: May 12, 2014    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018

Keywords provided by Ylva Hellsten, University of Copenhagen:
premenopausal
postmenopausal
cardiovascular
exercise training
vascular function
cardiac function
cardiac morphology
health

Additional relevant MeSH terms:
Cardiovascular Diseases
Metabolic Diseases
Blood Platelet Disorders
Hematologic Diseases