Physical Activity and Metabolic Risk Factors in Postmenopausal Women

NCT01259661 | Unknown

• 1 other identifier: 99070
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Postmenopausal women's daily energy expenditure

  12 week

Study Arms (2)

Experimental Group

EXPERIMENTAL

Other: A longitudinal intervention

Control Group

ACTIVE COMPARATOR

Other: A longitudinal intervention

Interventions

A longitudinal intervention 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; Experimental Group

Eligibility Criteria

• Age: 35 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• None of the participants has a diagnosis of type 2 diabetes, physical illness or disabilities that will limit daily physical activities.

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: lead

Study Sites (1)

Taipei Medical University WanFang Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Motor Activity; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Behavior; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jen-Chen Tsai

  Taipei Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jen-Chen Tsai

CONTACT

886-2-27361661; jenchent@tmu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 7, 2010
• First Posted: December 14, 2010
• Study Start: October 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2012
• Last Updated: December 14, 2010

Record last verified: 2010-12

Locations

TW (1)