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

Primary Purpose

Menopause, Cardiac Function Impaired, Cardiovascular Diseases

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Spinning
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Menopause focused on measuring premenopausal, postmenopausal, cardiovascular, exercise training, vascular function, cardiac function, cardiac morphology, health

Eligibility Criteria

45 Years - 57 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Copenhagen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Premenopausal women

Postmenopausal women

Arm Description

The Premenopausal women are randomized to exercise by spinning (cycle)

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

Outcomes

Primary Outcome Measures

Leg vascular function
Measurements of leg blood flow by ultrasound doppler during exercise and during femoral arterial infusion of vasodilators
Cardiac structure and function
Magnetic resonance imaging and transthoracic echocardiography
Platelet function
Platelet aggregation assay of whole blood and platelet rich plasma

Secondary Outcome Measures

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

Full Information

First Posted
April 1, 2014
Last Updated
August 14, 2018
Sponsor
University of Copenhagen
Collaborators
Glostrup University Hospital, Copenhagen, Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT02135575
Brief Title
Effects of Exercise Training on Cardiovascular Health in Middle-aged Women
Official Title
Effects of Exercise Training on Cardiovascular Health in Middle-aged Women
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
Glostrup University Hospital, Copenhagen, Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menopause, Cardiac Function Impaired, Cardiovascular Diseases, Blood Platelet Disorders, Metabolic Diseases
Keywords
premenopausal, postmenopausal, cardiovascular, exercise training, vascular function, cardiac function, cardiac morphology, health

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Premenopausal women
Arm Type
Experimental
Arm Description
The Premenopausal women are randomized to exercise by spinning (cycle)
Arm Title
Postmenopausal women
Arm Type
Experimental
Arm Description
The Postmenopausal women are randomized to exercise by spinning (cycle)
Intervention Type
Behavioral
Intervention Name(s)
Spinning
Intervention Description
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 Measure Information:
Title
Leg vascular function
Description
Measurements of leg blood flow by ultrasound doppler during exercise and during femoral arterial infusion of vasodilators
Time Frame
Baseline comparison and changes from baseline to 3 months
Title
Cardiac structure and function
Description
Magnetic resonance imaging and transthoracic echocardiography
Time Frame
Baseline comparison and changes from baseline to 3 months
Title
Platelet function
Description
Platelet aggregation assay of whole blood and platelet rich plasma
Time Frame
Baseline comparison and changes from baseline to 3 months
Secondary Outcome Measure Information:
Title
Expression of proteins in muscle samples
Description
Western Blot analysis of proteins of relevance for vascular function and metabolism
Time Frame
Baseline comparison and changes from baseline to 3 months
Title
Maximal aerobic effect
Description
Maximal oxygen uptake during an incremental cycle ergometry test with gas analysis
Time Frame
Baseline comparison and changes from baseline to 3 months
Title
Genomic profile in blood samples
Description
Genomic analysis of parameters for vascular and metabolic health
Time Frame
Baseline comparison and changes from baseline to 3 months
Title
Insulin sensitivity and glycaemic control
Description
Fasting plasma glucose analysis and oral glucose tolerance test
Time Frame
Baseline comparison and changes from baseline to 3 months
Title
Arterial blood pressure
Time Frame
Baseline comparison and changes from baseline to 3 months
Title
Gene expression of proteins in muscle samples
Description
Gene analysis of relevance for vascular and metabolic function
Time Frame
Baseline comparison and changes from baseline to 3 months
Title
Health related parameters in blood
Description
Plasma lipid status and other variables related to vascular health
Time Frame
Baseline comparison and changes from baseline to 3 months
Other Pre-specified Outcome Measures:
Title
Anthropometry
Description
Dual x-ray absorptiometry, height, weight, waist and hip circumference
Time Frame
Baseline comparison and changes from baseline to 3 months
Title
Activity measure
Description
Activity measure for one week by accelerometer
Time Frame
Baseline comparison and changes from baseline to 3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
57 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik Richter, MD PhD
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Copenhagen
City
Copenhagen
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
28862950
Citation
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.
Results Reference
derived

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

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