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Physical Activity and Metabolic Risk Factors in Postmenopausal Women

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2010 by Taipei Medical University WanFang Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01259661
First Posted: December 14, 2010
Last Update Posted: December 14, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Taipei Medical University WanFang Hospital
  Purpose

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.


Condition Intervention
Postmenopausal Women Other: A longitudinal intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Physical Activity and Metabolic Risk Factors in Postmenopausal Women

Resource links provided by NLM:


Further study details as provided by Taipei Medical University WanFang Hospital:

Primary Outcome Measures:
  • Postmenopausal women's daily energy expenditure [ Time Frame: 12 week ]

Estimated Enrollment: 50
Study Start Date: October 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental Group Other: A longitudinal intervention
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.
Active Comparator: Control Group Other: A longitudinal intervention
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • None of the participants has a diagnosis of type 2 diabetes, physical illness or disabilities that will limit daily physical activities.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01259661


Contacts
Contact: Jen-Chen Tsai 886-2-27361661 ext 6308 jenchent@tmu.edu.tw

Locations
Taiwan
Taipei Medical University WanFang Hospital Recruiting
Taipei, Taiwan
Contact: Jen-Chen Tsai    886-2-27361661 ext 6308    jenchent@tmu.edu.tw   
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Investigators
Principal Investigator: Jen-Chen Tsai Taipei Medical University
  More Information

Responsible Party: Jen-Chen Tsai, School of Nursing, Taipei Medical University
ClinicalTrials.gov Identifier: NCT01259661     History of Changes
Other Study ID Numbers: 99070
First Submitted: December 7, 2010
First Posted: December 14, 2010
Last Update Posted: December 14, 2010
Last Verified: December 2010

Keywords provided by Taipei Medical University WanFang Hospital:
physical activity
metabolic syndrome
postmenopausal women
exercise training