Clinical trial NCT02001376: A Health Promotion Project for Workers at National Taiwan University Hospital
Official title: A Health Promotion Project for Workers at National Taiwan University Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Abdominal Obesity Metabolic Syndrome
Subjects With Poor Fitness Status
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-12-04
Enrollment: 240
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: All improve fitness status
timeFrame: 36 weeks
Secondary outcomes:
measure: All improve fitness status
timeFrame: 36 weeks
Other outcomes:
measure: All improve fitness status
timeFrame: 36 weeks
measure: All improve fitness status
timeFrame: 36 weeks
measure: All improve fitness status
timeFrame: 36 weeks
measure: All improve fitness status
timeFrame: 36 weeks
measure: All improve fitness status
timeFrame: 36 weeks
Locations:
city: Taipei
country: Taiwan
facility: Physical Therapy Center, National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Jau-Yih Tsauo, PhD
role: STUDY_CHAIR
References: