A Health Promotion Project for Workers at National Taiwan University Hospital
Primary Purpose
Abdominal Obesity Metabolic Syndrome, Subjects With Poor Fitness Status
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Intensive exercise
Home exercise
Control group live as usual
Sponsored by
About this trial
This is an interventional treatment trial for Abdominal Obesity 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
Sites / Locations
- Physical Therapy Center, National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Intensive exercise & home exercise
Intensive exercise & control
Home exercise & control group
Arm Description
Intensive exercise group Home exercise group
Intensive exercise group Control group
Home exercise Control group
Outcomes
Primary Outcome Measures
All improve fitness status
Body mass index, BMI is calculated by dividing a person's weight (in kilograms) by his or her height (in meters, squared).
Secondary Outcome Measures
All improve fitness status
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.
Full Information
NCT ID
NCT02001376
First Posted
September 25, 2013
Last Updated
October 31, 2019
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02001376
Brief Title
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
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
August 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Obesity Metabolic Syndrome, Subjects With Poor Fitness Status
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intensive exercise & home exercise
Arm Type
Experimental
Arm Description
Intensive exercise group Home exercise group
Arm Title
Intensive exercise & control
Arm Type
Experimental
Arm Description
Intensive exercise group Control group
Arm Title
Home exercise & control group
Arm Type
Experimental
Arm Description
Home exercise Control group
Intervention Type
Other
Intervention Name(s)
Intensive exercise
Intervention Description
The intensive exercise group will receive moderate aerobic exercise and strengthening exercise three times a week for three months.
Intervention Type
Other
Intervention Name(s)
Home exercise
Intervention Description
The home-based exercise group will receive exercise instruction biweekly for three months
Intervention Type
Other
Intervention Name(s)
Control group live as usual
Other Intervention Name(s)
Control group
Intervention Description
Control group means no any intervention for them. The control group who with metabolic syndrome risk factors just live as usual.
Primary Outcome Measure Information:
Title
All improve fitness status
Description
Body mass index, BMI is calculated by dividing a person's weight (in kilograms) by his or her height (in meters, squared).
Time Frame
36 weeks
Secondary Outcome Measure Information:
Title
All improve fitness status
Description
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.
Time Frame
36 weeks
Other Pre-specified Outcome Measures:
Title
All improve fitness status
Description
muscle strength The Curl-Up Test is to assess the endurance of the subjects' abdominal muscles.
Time Frame
36 weeks
Title
All improve fitness status
Description
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.
Time Frame
36 weeks
Title
All improve fitness status
Description
balance One leg standing with eye-closed, assess bilateral legs.
Time Frame
36 weeks
Title
All improve fitness status
Description
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.
Time Frame
36 weeks
Title
All improve fitness status
Description
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.
Time Frame
36 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jau-Yih Tsauo, PhD
Phone
886-2-33668130
Email
jytsauo@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jau-Yih Tsauo, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Physical Therapy Center, National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jau-Yih Tsauo, PhD, PT
Phone
+886-2-33668130
Email
jytsauo@ntu.edu.tw
First Name & Middle Initial & Last Name & Degree
Chia-Te Lin, M.S. PT
Phone
+886-2-23123456
Ext
66515
Email
chiatelin@ntuh.gov.tw
12. IPD Sharing Statement
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A Health Promotion Project for Workers at National Taiwan University Hospital
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