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
Sponsor:
Information provided by:
Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT01259661
First received: December 7, 2010
Last updated: December 12, 2010
Last verified: December 2010
  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: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   35 Years to 64 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Jen-Chen Tsai, School of Nursing, Taipei Medical University
ClinicalTrials.gov Identifier: NCT01259661     History of Changes
Other Study ID Numbers: 99070
Study First Received: December 7, 2010
Last Updated: December 12, 2010
Health Authority: Taiwan: Department of Health

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

ClinicalTrials.gov processed this record on July 29, 2014