Postmenopausal DisorderNCT01398605
Physical Activity in Postmenopausal Women
A study testing Exercise training in people with Postmenopausal Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The study is designed to investigate the physical activity and its dose-response relationship in postmenopausal women on the cardiovascular risks and cardiac function. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Disorder
- What is being tested?
- Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2008to Jul 2010
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal women aged 40 to 80 years and age matched men without major diseases
Who cannot join
- Known cardiac disease, excessive weight change during last year, cancer and mental disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical Activity and Exercise Dose-response on Cardiovascular Risk Factors in Postmenopausal Women
The study is designed to investigate the physical activity and its dose-response relationship in postmenopausal women on the cardiovascular risks and cardiac function.
- Conditions
- Postmenopausal Disorder
- Being tested
- Exercise training
- Keywords
- Postmenopausal women, Physical activity, Cardiovascular risks, Cardiac function, Dose-response
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
Different dose of exercise training
| Study group | Role | What they receive |
|---|---|---|
| moderate exercise training | Experimental | Not described Receives: Other: Exercise training |
| intensive exercise training | Experimental | Not described Receives: Other: Exercise training |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index (BMI)
Measured: 3 months
Waist circumference
Measured: 3 months
Lab data (lipid profile, CRP, insulin resistance)
Measured: 3 months
QT interval and corrected QT interval (QTc)
Measured: 3 months
Cardiovascular fitness
Measured: 3 months
Heart rate recovery after exercise test
Measured: 3 months
Secondary outcomes (1)
Myocardial perfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2011 (estimated)
- Study startSep 2008
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal DisorderStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ying-Tai Wu, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01398605
- Sponsor's protocol ID
- 200709026R
- Status last verified
- Jul 2011
- First submitted
- 14 Jul 2011
- Last updated
- 18 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity and Exercise Dose-response on Cardiovascular Risk Factors in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT01398605
- Acronym / sponsor ID
- 200709026R
- Conditions
- Postmenopausal Disorder
- Keywords
- Postmenopausal women, Physical activity, Cardiovascular risks, Cardiac function, Dose-response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 20 Jul 2011 (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 study is designed to investigate the physical activity and its dose-response relationship in postmenopausal women on the cardiovascular risks and cardiac function.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| moderate exercise training | Experimental | Other: Exercise training |
| intensive exercise training | Experimental | Other: Exercise training |
| Control | No intervention | – |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Postmenopausal women aged 40 to 80 years and age matched men without major diseases
Key exclusion criteria (1 listed)
- Known cardiac disease, excessive weight change during last year, cancer and mental disorders
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 |
|---|---|---|
| Exercise trainingDifferent dose of exercise training | Other | intensive exercise training, moderate exercise training |
Primary outcome
Body mass index (BMI)
Time frame: 3 months
Waist circumference
Time frame: 3 months
Lab data (lipid profile, CRP, insulin resistance)
Time frame: 3 months
QT interval and corrected QT interval (QTc)
Time frame: 3 months
Cardiovascular fitness
Time frame: 3 months
Heart rate recovery after exercise test
Time frame: 3 months
1 secondary outcome
Myocardial perfusion
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 18 Aug 2011.
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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.
Ying-Tai Wu, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Postmenopausal Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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 18 Aug 2011. 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 Taiwan. 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?
Body mass index (BMI) (time frame: 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Aug 2011.