A Health Promotion Project for Workers at National Taiwan University Hospital

NCT ID: NCT02001376

Last Updated: 2019-11-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2020-08-31

Brief Summary

Background and Purpose: Fitness is the foundation for health and quality of life for individuals. Recent changes in lifestyle and eating habit in Taiwan have significantly increased the prevalence of metabolic syndrome that may lead to poor fitness and subsequent coronary artery disease, cardiovascular disease and diabetes. Although workers at the National Taiwan University Hospital (NTUH) have undertaken regular health fitness examination, the examination did not include the posture and movement analysis and no exercise intervention was provided to those with metabolic syndrome. This study is therefore aimed to conduct comprehensive health fitness examination for workers at NTUH and to examine whether exercise intervention could decrease the risk factors and enhance fitness in those at risk or with metabolic syndrome. Methods: This study will consist of two parts. In the first part, 1102 workers at NTUH will be administered comprehensive fitness examination (body mass index, waist circumference, muscle strength, flexibility, balance, cardiopulmonary test, and posture and movement analysis) and will be assessed with the Physical Activity Readiness and the Perceived Musculoskeletal Pain Scale and the International Physical Activity Questionnaire. Those workers who are at risk or have metabolic syndrome (N=240) will be assigned into the control, home-based exercise, and intensive exercise group with 80 in each group with their will. The home-based exercise group will receive exercise instruction biweekly for three months; the intensive exercise group will receive moderate aerobic exercise and strengthening exercise three times a week for three months. The other workers who are insufficient fitness status (N=240) will be assigned into the control, home-based exercise, and intensive exercise group with their will. The home-based exercise group will receive exercise instruction biweekly for a month; the intensive exercise group with 80 in each group will receive moderate aerobic exercise and strengthening exercise three times a week for a month. Descriptive statistics will be used to estimate the prevalence of 1, 2 and ≧3 metabolic risk factors, and poor fitness. One-way analysis of variance (ANOVA) will be used to examine the relation between metabolic syndrome risk factors and fitness. One-way ANOVA will be used to compare the demographic characteristics of the control, home-based exercise, and intensive exercise group. Two-way ANOVA repeated measures will be used to examine the metabolic syndrome risk factors and fitness in the three groups across time. Clinical relevance: Our results will help understand the health fitness of workers at NTUH and will assist in establishing effective exercise program for those at risk or with metabolic syndrome.

Conditions

Abdominal Obesity Metabolic Syndrome; Subjects With Poor Fitness Status

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intensive exercise & home exercise

Intensive exercise group Home exercise group

Group Type: EXPERIMENTAL

Intensive exercise

Intervention Type: OTHER

The intensive exercise group will receive moderate aerobic exercise and strengthening exercise three times a week for three months.

Home exercise

Intervention Type: OTHER

The home-based exercise group will receive exercise instruction biweekly for three months

Intensive exercise & control

Intensive exercise group Control group

Group Type: EXPERIMENTAL

Intensive exercise

Intervention Type: OTHER

The intensive exercise group will receive moderate aerobic exercise and strengthening exercise three times a week for three months.

Control group live as usual

Intervention Type: OTHER

Control group means no any intervention for them. The control group who with metabolic syndrome risk factors just live as usual.

Home exercise & control group

Home exercise Control group

Group Type: EXPERIMENTAL

Home exercise

Intervention Type: OTHER

The home-based exercise group will receive exercise instruction biweekly for three months

Control group live as usual

Intervention Type: OTHER

Control group means no any intervention for them. The control group who with metabolic syndrome risk factors just live as usual.

Interventions

Intensive exercise

The intensive exercise group will receive moderate aerobic exercise and strengthening exercise three times a week for three months.

Intervention Type: OTHER

Home exercise

The home-based exercise group will receive exercise instruction biweekly for three months

Intervention Type: OTHER

Control group live as usual

Control group means no any intervention for them. The control group who with metabolic syndrome risk factors just live as usual.

Intervention Type: OTHER

Other Intervention Names

Control group

Eligibility Criteria

Inclusion Criteria

• Age between 20-60 years old
• At least one metabolic syndrome risk factor (Elevated blood pressure: Equal to or greater than 120/80 mm Hg, Central obesity: waist circumference ≥ 90 cm (male), ≥ 80 cm (female), Elevated triglycerides: Equal to or greater than 150 mg/dL, Reduced HDL cholesterol: Men - Less than 40 mg/dL Women - Less than 50 mg/dL, Elevated fasting glucose: Equal to or greater than 100 mg/dL)

Exclusion Criteria

• diastolic blood pressure greater than 139 mm Hg or systolic blood pressure greater than 89 mm Hg
• fasting glucose greater than 125 mg/dL
• triglycerides greater than 199 mg/dL
• Subjects have in progress cardiovascular disease or in treatment course
• chest distress, short of breath, dizziness, faint in recent 3 months
• Muscular skeletal system injury or pain

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jau-Yih Tsauo, PhD

Role: STUDY_CHAIR

National Taiwan University Hospital

Locations

Physical Therapy Center, National Taiwan University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Jau-Yih Tsauo, PhD

Role: CONTACT

jytsauo@ntu.edu.tw

886-2-33668130

Facility Contacts

Jau-Yih Tsauo, PhD, PT

Role: primary

jytsauo@ntu.edu.tw

+886-2-33668130

Chia-Te Lin, M.S. PT

Role: backup

chiatelin@ntuh.gov.tw

+886-2-23123456 ext. 66515

Other Identifiers

201007040R

Identifier Type: -

Identifier Source: org_study_id