Postmenopausal WomenNCT01259661
Physical Activity and Metabolic Risk Factors in Postmenopausal Women
A study testing A longitudinal intervention in people with Postmenopausal Women, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
Hormonal changes associated with menopause, chronological aging, and lifestyle, especially physical inactivity, may increase the risk of metabolic syndrome in postmenopausal women. Read more about this study
- Who is it for?
- Ages 35 to 64 years, women only
- Conditions the study is for
- Postmenopausal Women
- What is being tested?
- A longitudinal intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2010to Oct 2012
- 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 35 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- have one or more metabolic risk variables as defined by the ATP III (2001)
- age between 35 and 64 years
- absence of known heart disease
- resting BP: 130 < SBP < 160 and 85 < DBP < 100
- currently physical inactive (< 30 min of physical activity per week)
Who cannot join
- None of the participants has a diagnosis of type 2 diabetes, physical illness or disabilities that will limit daily physical activities.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University WanFang Hospital
Taipei
Jen-Chen Tsai, 886-2-27361661 ext. 6308, jenchent@tmu.edu.tw
About this study
Hormonal changes associated with menopause, chronological aging, and lifestyle, especially physical inactivity, may increase the risk of metabolic syndrome in postmenopausal women. Women exhibiting "the metabolic syndrome" have multiple coronary artery disease risk factors, including insulin resistance, hyperlipidemia, and hypertension. This study will be conducted to test the hypotheses: (1) physical activity and physical fitness levels may have effects on individual risk factors of the metabolic syndrome in postmenopausal women; (2) endurance exercise training may have a favorable effect on components of the metabolic risk variables in these women.
In this study, the associations among physical activity (including daily energy expenditure and energy expenditure from moderate to vigorous activity), cardiopulmonary fitness level, and metabolic risk profile of the women will be assessed. The investigators will perform a randomized trial to compare the effects of moderate-intensity aerobic exercise training regimens on metabolic risk factors. Postmenopausal women who exhibit at least one risk factor for metabolic syndrome will be randomized in the exercise group or control groups. Metabolic risk factors (e.g., body mass index, waist-to-hip ratio, glucose, insulin, blood pressure, lipid profile and adiponectin level) will be measured at baseline, and 12 weeks of the study. Differences from baseline to follow-up will be calculated and compared across groups.
Results of this study may help health care providers providing advice to postmenopausal women for life style changes to reduce risk of insulin resistance, coronary heart disease, and diabetes.
- Conditions
- Postmenopausal Women
- Being tested
- A longitudinal intervention
- Keywords
- physical activity, metabolic syndrome, postmenopausal women, exercise training
- Medical subject headings
- Motor Activity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A longitudinal interventionOther
In our longitudinal intervention study, all eligible subjects will undergo a physical examination by a physician to rule out obvious secondary causes of hypertension and contraindications to exercise. Randomization will be performed by random member generation. The exercise participants will attend three sessions per week at the facility during the study period. Training intensity is initially set at heart rate equivalent to 60% and progress to 80% of each subject's maximal heart rate reserve for 30 min/day with a frequency of 3 days/wk. Facility-based exercise sessions will consist of treadmill walking.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Not described Receives: Other: A longitudinal intervention |
| Control Group | Active comparator | Not described Receives: Other: A longitudinal intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postmenopausal women's daily energy expenditure
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2010 (estimated)
- Study startOct 2010
- Primary completionOct 2011 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal WomenStudies of the same condition, open and under way.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jen-Chen Tsai, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01259661
- Sponsor's protocol ID
- 99070
- Status last verified
- Dec 2010
- First submitted
- 7 Dec 2010
- Last updated
- 14 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity and Metabolic Risk Factors in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT01259661
- Acronym / sponsor ID
- 99070
- Conditions
- Postmenopausal Women
- Keywords
- physical activity, metabolic syndrome, postmenopausal women, exercise training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 14 Dec 2010 (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.
Hormonal changes associated with menopause, chronological aging, and lifestyle, especially physical inactivity, may increase the risk of metabolic syndrome in postmenopausal women. Women exhibiting "the metabolic syndrome" have multiple coronary artery disease risk factors, including insulin resistance, hyperlipidemia, and hypertension. This study will be conducted to test the hypotheses: (1) physical activity and physical fitness levels may have effects on individual risk factors of the metabolic syndrome in postmenopausal women; (2) endurance exercise training may have a favorable effect on components of the metabolic risk variables in these women.
In this study, the associations among physical activity (including daily energy expenditure and energy expenditure from moderate to vigorous activity), cardiopulmonary fitness level, and metabolic risk profile of the women will be assessed. The investigators will perform a randomized trial to compare the effects of moderate-intensity aerobic exercise training regimens on metabolic risk factors. Postmenopausal women who exhibit at least one risk factor for metabolic syndrome will be randomized in the exercise group or control groups. Metabolic risk factors (e.g., body mass index, waist-to-hip ratio, glucose, insulin, blood pressure, lipid profile and adiponectin level) will be measured at baseline, and 12 weeks of the study. Differences from baseline to follow-up will be calculated and compared across groups.
Results of this study may help health care providers providing advice to postmenopausal women for life style changes to reduce risk of insulin resistance, coronary heart disease, and diabetes.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: A longitudinal intervention |
| Control Group | Active comparator | Other: A longitudinal intervention |
Who may qualify
- Ages
- 35 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- have one or more metabolic risk variables as defined by the ATP III (2001)
- age between 35 and 64 years
- absence of known heart disease
- resting BP: 130 < SBP < 160 and 85 < DBP < 100
- currently physical inactive (< 30 min of physical activity per week)
Key exclusion criteria (1 listed)
- None of the participants has a diagnosis of type 2 diabetes, physical illness or disabilities that will limit daily physical activities.
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 |
|---|---|---|
| A longitudinal interventionIn our longitudinal intervention study, all eligible subjects will undergo a physical examination by a physician to rule out obvious secondary causes of hypertension and contraindications to exercise. Randomization will be performed by random member generation. The exercise participants will attend three sessions per week at the facility during the study period. Training intensity is initially set at heart rate equivalent to 60% and progress to 80% of each subject's maximal heart rate reserve for 30 min/day with a frequency of 3 days/wk. Facility-based exercise sessions will consist of treadmill walking. | Other | Control Group, Experimental Group |
Primary outcome
Postmenopausal women's daily energy expenditure
Time frame: 12 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2010.
Related trials for Postmenopausal Women
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Active, not recruiting
AI-Supported Mobile High-Impact and Strengthening Exercise Program in Postmenopausal Women With Low Bone Density
Osteopenia
Not yet recruiting
The Role of Diet Quality in Sleep Among Women in Postmenopause
Post Menopausal Women
Not yet recruitingObservational study
Spousal Support and Sexual Quality of Life in Postmenopausal Women
Postmenopausal, Support
Not yet recruitingObservational study
Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With Obesity
Obesity, Morbid, Postmenopause
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.
Jen-Chen Tsai principal investigator
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A longitudinal intervention in people with Postmenopausal Women, run by Taipei Medical University WanFang 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 5 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: status not confirmed, as of the sponsor's last update on 14 Dec 2010. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jen-Chen Tsai (886-2-27361661 ext. 6308, jenchent@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postmenopausal women's daily energy expenditure (time frame: 12 week). 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 14 Dec 2010.