NCT02135575

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 12, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

August 16, 2018

Status Verified

August 1, 2018

Enrollment Period

3.2 years

First QC Date

April 1, 2014

Last Update Submit

August 14, 2018

Conditions

MenopauseCardiac Function ImpairedCardiovascular DiseasesBlood Platelet DisordersMetabolic Diseases

Keywords

premenopausalpostmenopausalcardiovascularexercise trainingvascular functioncardiac functioncardiac morphologyhealth

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (7)

  • Expression of proteins in muscle samples

    Baseline comparison and changes from baseline to 3 months

  • Maximal aerobic effect

    Baseline comparison and changes from baseline to 3 months

  • Genomic profile in blood samples

    Baseline comparison and changes from baseline to 3 months

  • Insulin sensitivity and glycaemic control

    Baseline comparison and changes from baseline to 3 months

  • Arterial blood pressure

    Baseline comparison and changes from baseline to 3 months

  • +2 more secondary outcomes

Other Outcomes (2)

  • Anthropometry

    Baseline comparison and changes from baseline to 3 months

  • Activity measure

    Baseline comparison and changes from baseline to 3 months

Study Arms (2)

Premenopausal women

EXPERIMENTAL

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

Behavioral: Spinning

Postmenopausal women

EXPERIMENTAL

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

Behavioral: Spinning

Interventions

SpinningBEHAVIORAL

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.

Postmenopausal womenPremenopausal women

Eligibility Criteria

Age45 Years - 57 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Smoking
  • Excessive alcohol intake
  • Regular medication including hormone replacement treatment
  • Chronic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Copenhagen

Copenhagen, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 28862950DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesBlood Platelet DisordersMetabolic Diseases

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Erik Richter, MD PhD

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 1, 2014

First Posted

May 12, 2014

Study Start

May 1, 2014

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

August 16, 2018

Record last verified: 2018-08

Locations

DK(1)