- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02001376
A Health Promotion Project for Workers at National Taiwan University Hospital
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jau-Yih Tsauo, PhD
- Phone Number: 886-2-33668130
- Email: jytsauo@ntu.edu.tw
Study Locations
-
-
-
Taipei, Taiwan
- Recruiting
- Physical Therapy Center, National Taiwan University Hospital
-
Contact:
- Jau-Yih Tsauo, PhD, PT
- Phone Number: +886-2-33668130
- Email: jytsauo@ntu.edu.tw
-
Contact:
- Chia-Te Lin, M.S. PT
- Phone Number: 66515 +886-2-23123456
- Email: chiatelin@ntuh.gov.tw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
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:
|
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
Investigators
- Study Chair: Jau-Yih Tsauo, PhD, National Taiwan University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201007040R
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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