Overview

This trial is active, not recruiting.

Conditions menopause, cardiac function impaired, cardiovascular diseases, blood platelet disorders, metabolic diseases
Treatment spinning
Sponsor University of Copenhagen
Collaborator Glostrup University Hospital, Copenhagen
Start date May 2014
End date December 2016
Trial size 40 participants
Trial identifier NCT02135575, CWS-WP2CV

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
The Premenopausal women are randomized to exercise by spinning (cycle)
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)
The Postmenopausal women are randomized to exercise by spinning (cycle)
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 Outcomes

Measure
Leg vascular function
time frame: Baseline comparison and changes from baseline to 3 months
Cardiac structure and function
time frame: Baseline comparison and changes from baseline to 3 months
Platelet function
time frame: Baseline comparison and changes from baseline to 3 months

Secondary Outcomes

Measure
Expression of proteins in muscle samples
time frame: Baseline comparison and changes from baseline to 3 months
Maximal aerobic effect
time frame: Baseline comparison and changes from baseline to 3 months
Genomic profile in blood samples
time frame: Baseline comparison and changes from baseline to 3 months
Insulin sensitivity and glycaemic control
time frame: Baseline comparison and changes from baseline to 3 months
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
Health related parameters in blood
time frame: Baseline comparison and changes from baseline to 3 months

Eligibility Criteria

Female participants from 45 years up to 57 years old.

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

Additional Information

Official title Effects of Exercise Training on Cardiovascular Health in Middle-aged Women
Principal investigator Erik Richter, MD PhD
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by University of Copenhagen.