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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Metabolic Diseases; Blood Platelet Disorders; Menopause; Cardiac Function Impaired
• Intervention / Treatment: Behavioral: Spinning

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • University of Copenhagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 57 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Leg vascular function	Measurements of leg blood flow by ultrasound doppler during exercise and during femoral arterial infusion of vasodilators	Baseline comparison and changes from baseline to 3 months
Cardiac structure and function	Magnetic resonance imaging and transthoracic echocardiography	Baseline comparison and changes from baseline to 3 months
Platelet function	Platelet aggregation assay of whole blood and platelet rich plasma	Baseline comparison and changes from baseline to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expression of proteins in muscle samples	Western Blot analysis of proteins of relevance for vascular function and metabolism	Baseline comparison and changes from baseline to 3 months
Maximal aerobic effect	Maximal oxygen uptake during an incremental cycle ergometry test with gas analysis	Baseline comparison and changes from baseline to 3 months
Genomic profile in blood samples	Genomic analysis of parameters for vascular and metabolic health	Baseline comparison and changes from baseline to 3 months
Insulin sensitivity and glycaemic control	Fasting plasma glucose analysis and oral glucose tolerance test	Baseline comparison and changes from baseline to 3 months
Arterial blood pressure		Baseline comparison and changes from baseline to 3 months
Gene expression of proteins in muscle samples	Gene analysis of relevance for vascular and metabolic function	Baseline comparison and changes from baseline to 3 months
Health related parameters in blood	Plasma lipid status and other variables related to vascular health	Baseline comparison and changes from baseline to 3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anthropometry	Dual x-ray absorptiometry, height, weight, waist and hip circumference	Baseline comparison and changes from baseline to 3 months
Activity measure	Activity measure for one week by accelerometer	Baseline comparison and changes from baseline to 3 months

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: Rigshospitalet, Denmark; Glostrup University Hospital, Copenhagen
• Investigators: Principal Investigator: Erik Richter, MD PhD, University of Copenhagen

Publications and helpful links

General Publications

• Egelund J, Jorgensen 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):e005469. doi: 10.1161/JAHA.117.005469.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: April 1, 2014
• First Submitted That Met QC Criteria: May 6, 2014
• First Posted (Estimate): May 12, 2014

Study Record Updates

• Last Update Posted (Actual): August 16, 2018
• Last Update Submitted That Met QC Criteria: August 14, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: health; exercise training; vascular function; postmenopausal; premenopausal; cardiovascular; cardiac function; cardiac morphology
• Additional Relevant MeSH Terms: Hematologic Diseases; Cardiovascular Diseases; Metabolic Diseases; Blood Platelet Disorders
• Other Study ID Numbers: CWS-WP2CV