MenopauseNCT02135575
Effects of Exercise Training on Cardiovascular Health in Middle-aged Women
A study testing Spinning in people with Menopause and Cardiac Function Impaired, run by University of Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 57 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Cardiac Function Impaired, Cardiovascular Diseases
- What is being tested?
- Spinning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteDenmark
- Study dates
- May 2014to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 57 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Smoking
- Excessive alcohol intake
- Regular medication including hormone replacement treatment
- Chronic disease
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Menopause, Cardiac Function Impaired, Cardiovascular Diseases, Blood Platelet Disorders, Metabolic Diseases
- Being tested
- Spinning
- Keywords
- premenopausal, postmenopausal, cardiovascular, exercise training, vascular function, cardiac function, cardiac morphology, health
- Medical subject headings
- Cardiovascular Diseases, Blood Platelet Disorders, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpinningBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Premenopausal women | Experimental | The Premenopausal women are randomized to exercise by spinning (cycle) Receives: Behavioral: Spinning |
| Postmenopausal women | Experimental | The Postmenopausal women are randomized to exercise by spinning (cycle) Receives: Behavioral: Spinning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leg vascular function
Measurements of leg blood flow by ultrasound doppler during exercise and during femoral arterial infusion of vasodilators
Measured: Baseline comparison and changes from baseline to 3 months
Cardiac structure and function
Magnetic resonance imaging and transthoracic echocardiography
Measured: Baseline comparison and changes from baseline to 3 months
Platelet function
Platelet aggregation assay of whole blood and platelet rich plasma
Measured: Baseline comparison and changes from baseline to 3 months
Secondary outcomes (7)
Expression of proteins in muscle samples
Western Blot analysis of proteins of relevance for vascular function and metabolism
Measured: Baseline comparison and changes from baseline to 3 months
Maximal aerobic effect
Maximal oxygen uptake during an incremental cycle ergometry test with gas analysis
Measured: Baseline comparison and changes from baseline to 3 months
Genomic profile in blood samples
Genomic analysis of parameters for vascular and metabolic health
Measured: Baseline comparison and changes from baseline to 3 months
Insulin sensitivity and glycaemic control
Fasting plasma glucose analysis and oral glucose tolerance test
Measured: Baseline comparison and changes from baseline to 3 months
Arterial blood pressure
Measured: 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
Measured: Baseline comparison and changes from baseline to 3 months
Health related parameters in blood
Plasma lipid status and other variables related to vascular health
Measured: Baseline comparison and changes from baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2014 (estimated)
- Study startMay 2014
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Glostrup University Hospital, Copenhagen, Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Ylva Hellsten, University of Copenhagen
- Investigators
- Erik Richter, MD PhD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02135575
- Sponsor's protocol ID
- CWS-WP2CV
- Status last verified
- Aug 2018
- First submitted
- 1 Apr 2014
- Last updated
- 16 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 28862950
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise Training on Cardiovascular Health in Middle-aged Women
- ClinicalTrials.gov ID
- NCT02135575
- Acronym / sponsor ID
- CWS-WP2CV
- Conditions
- Menopause, Cardiac Function Impaired, Cardiovascular Diseases, Blood Platelet Disorders, Metabolic Diseases
- Keywords
- premenopausal, postmenopausal, cardiovascular, exercise training, vascular function, cardiac function, cardiac morphology, health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Glostrup University Hospital, Copenhagen, Copenhagen University Hospital, Rigshospitalet
- Study start
- May 2014
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 12 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Premenopausal women | Experimental | Behavioral: SpinningThe Premenopausal women are randomized to exercise by spinning (cycle) |
| Postmenopausal women | Experimental | Behavioral: SpinningThe Postmenopausal women are randomized to exercise by spinning (cycle) |
Who may qualify
- Ages
- 45 to 57 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Smoking
- Excessive alcohol intake
- Regular medication including hormone replacement treatment
- Chronic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpinningAfter 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. | Behavioural | Postmenopausal women, Premenopausal women |
Primary outcome
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
Cardiac structure and function
Time frame: Baseline comparison and changes from baseline to 3 months
Magnetic resonance imaging and transthoracic echocardiography
Platelet function
Time frame: Baseline comparison and changes from baseline to 3 months
Platelet aggregation assay of whole blood and platelet rich plasma
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
- Derived from this study: PubMed 28862950Egelund 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik Richter, MD PhD principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinning in people with Menopause and Cardiac Function Impaired, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leg vascular function (time frame: Baseline comparison and changes from baseline to 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02135575, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2018.