Physical Activity and Metabolic Risk Factors in Postmenopausal Women

Postmenopausal Women Clinical Trial

Official title:

Physical Activity and Metabolic Risk Factors in Postmenopausal Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01259661
• Other study ID #: 99070
• Status: Recruiting
• Phase: N/A
• First received: December 7, 2010
• Last updated: December 12, 2010
• Start date: October 2010
• Est. completion date: October 2012

Study information

• Verified date: December 2010
• Source: Taipei Medical University WanFang Hospital
• Contact: Jen-Chen Tsai
• Phone: 886-2-27361661
• Email: jenchent[@]tmu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 64 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Postmenopausal Women

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Taipei Medical University WanFang Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University WanFang Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postmenopausal women's daily energy expenditure		12 week	No