Physical Activity and Metabolic Risk Factors in Postmenopausal Women

NCT ID: NCT01259661

Last Updated: 2010-12-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2012-10-31

Brief 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.

Conditions

Postmenopausal Women

Keywords

physical activity; metabolic syndrome; postmenopausal women; exercise training

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Experimental Group

Group Type: EXPERIMENTAL

A longitudinal intervention

Intervention Type: OTHER

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.

Control Group

Group Type: ACTIVE_COMPARATOR

A longitudinal intervention

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Taipei Medical University WanFang Hospital

OTHER

Sponsor Role: lead

Responsible Party

School of Nursing, Taipei Medical University

Principal Investigators

Jen-Chen Tsai

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University

Locations

Taipei Medical University WanFang Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Jen-Chen Tsai

Role: CONTACT

Phone: 886-2-27361661

Email: jenchent@tmu.edu.tw

Facility Contacts

Jen-Chen Tsai

Role: primary

Other Identifiers

99070

Identifier Type: -

Identifier Source: org_study_id