A Health Promotion Project for Workers at National Taiwan University Hospital

October 31, 2019 updated by: National Taiwan University Hospital
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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Taipei, Taiwan
        • Recruiting
        • Physical Therapy Center, National Taiwan University Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intensive exercise & home exercise
Intensive exercise group Home exercise group
The intensive exercise group will receive moderate aerobic exercise and strengthening exercise three times a week for three months.
The home-based exercise group will receive exercise instruction biweekly for three months
Experimental: Intensive exercise & control
Intensive exercise group Control group
The intensive exercise group will receive moderate aerobic exercise and strengthening exercise three times a week for three months.
Control group means no any intervention for them. The control group who with metabolic syndrome risk factors just live as usual.
Other Names:
  • Control group
Experimental: Home exercise & control group
Home exercise Control group
The home-based exercise group will receive exercise instruction biweekly for three months
Control group means no any intervention for them. The control group who with metabolic syndrome risk factors just live as usual.
Other Names:
  • Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All improve fitness status
Time Frame: 36 weeks
Body mass index, BMI is calculated by dividing a person's weight (in kilograms) by his or her height (in meters, squared).
36 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All improve fitness status
Time Frame: 36 weeks

waist circumference To measure waist circumference locate the top of the hip bone. Place the tape measure evenly around the bare abdomen at the level of this bone. Read the tape measure and record the waist circumference in centimeters.

The following individuals are at increased risk for developing chronic diseases:

Women with a waist circumference of more than 80 centimeters. Men with a waist circumference of more than 90 centimeters.

36 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
All improve fitness status
Time Frame: 36 weeks
muscle strength The Curl-Up Test is to assess the endurance of the subjects' abdominal muscles.
36 weeks
All improve fitness status
Time Frame: 36 weeks
muscle flexibility The sit and reach test is a common measure of flexibility, and specifically measures the flexibility of the lower back and hamstring muscles.
36 weeks
All improve fitness status
Time Frame: 36 weeks
balance One leg standing with eye-closed, assess bilateral legs.
36 weeks
All improve fitness status
Time Frame: 36 weeks
cardiopulmonary index The 3-Minute Step Test measures subjects' aerobic (cardiovascular) fitness level based on how quickly subjects' heart rate returns to normal after exercise.
36 weeks
All improve fitness status
Time Frame: 36 weeks
posture and movement analysis Posture is more than how subject look when sitting or standing. Good posture is defined as the ideal spine alignment and body positioning that puts the least strain on the body. Good posture distribute weight and forces evenly so that no one body region is overstressed. Good posture reduces the stress on joints, protects the ligaments supporting the spine, and allows muscles to work efficiently to reduce fatigue. Bad posture puts abnormal stress on the spine and can cause premature development of conditions such as spine arthritis and degenerative disc disease. Good posture put the weight line straight along ear, acromial and great trochanter.
36 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Jau-Yih Tsauo, PhD, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Anticipated)

August 1, 2020

Study Completion (Anticipated)

August 1, 2020

Study Registration Dates

First Submitted

September 25, 2013

First Submitted That Met QC Criteria

December 3, 2013

First Posted (Estimate)

December 4, 2013

Study Record Updates

Last Update Posted (Actual)

November 4, 2019

Last Update Submitted That Met QC Criteria

October 31, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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