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Physical Activity and Metabolic Risk Factors in Postmenopausal Women

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Taipei Medical University WanFang Hospital.
Recruitment status was  Recruiting
Information provided by:
Taipei Medical University WanFang Hospital Identifier:
First received: December 7, 2010
Last updated: December 12, 2010
Last verified: December 2010

December 7, 2010
December 12, 2010
October 2010
October 2011   (final data collection date for primary outcome measure)
Postmenopausal women's daily energy expenditure [ Time Frame: 12 week ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01259661 on Archive Site
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Physical Activity and Metabolic Risk Factors in Postmenopausal Women
Physical Activity and Metabolic Risk Factors in Postmenopausal Women

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.

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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Postmenopausal Women
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.
  • Experimental: Experimental Group
    Intervention: Other: A longitudinal intervention
  • Active Comparator: Control Group
    Intervention: Other: A longitudinal intervention
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2012
October 2011   (final data collection date for primary outcome measure)

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.
35 Years to 64 Years
Contact: Jen-Chen Tsai 886-2-27361661 ext 6308
Jen-Chen Tsai, School of Nursing, Taipei Medical University
Taipei Medical University WanFang Hospital
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Principal Investigator: Jen-Chen Tsai Taipei Medical University
Taipei Medical University WanFang Hospital
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP