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.

Study Overview

• Status: Unknown
• Conditions: Postmenopausal Women
• Intervention / Treatment: Other: A longitudinal intervention

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • Taipei Medical University WanFang Hospital
    • Contact: Jen-Chen Tsai; Phone Number: 6308 886-2-27361661; Email: jenchent@tmu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Postmenopausal women's daily energy expenditure	12 week

Collaborators and Investigators

• Sponsor: Taipei Medical University WanFang Hospital
• Investigators: Principal Investigator: Jen-Chen Tsai, Taipei Medical University

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Anticipated): October 1, 2011
• Study Completion (Anticipated): October 1, 2012

Study Registration Dates

• First Submitted: December 7, 2010
• First Submitted That Met QC Criteria: December 12, 2010
• First Posted (Estimate): December 14, 2010

Study Record Updates

• Last Update Posted (Estimate): December 14, 2010
• Last Update Submitted That Met QC Criteria: December 12, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: physical activity; exercise training; metabolic syndrome; postmenopausal women
• Other Study ID Numbers: 99070