Abdominal Obesity Metabolic SyndromeNCT02001376
A Health Promotion Project for Workers at National Taiwan University Hospital
A study testing Intensive exercise and Home exercise in people with Abdominal Obesity Metabolic Syndrome and Subjects With Poor Fitness Status, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Abdominal Obesity Metabolic Syndrome, Subjects With Poor Fitness Status
- What is being tested?
- Intensive exercise and Home exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2011to Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Physical Therapy Center, National Taiwan University Hospital
Taipei
Jau-Yih Tsauo, PhD, PT, +886-2-33668130, jytsauo@ntu.edu.tw
Chia-Te Lin, M.S. PT, +886-2-23123456 ext. 66515, chiatelin@ntuh.gov.tw
About this study
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.
- Being tested
- Intensive exercise, Home exercise, Control group live as usual
- Medical subject headings
- Abdominal obesity metabolic syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive exerciseOther
The intensive exercise group will receive moderate aerobic exercise and strengthening exercise three times a week for three months.
Home exerciseOther
The home-based exercise group will receive exercise instruction biweekly for three months
Control group live as usualOther
Also called Control group
Control group means no any intervention for them. The control group who with metabolic syndrome risk factors just live as usual.
| Study group | Role | What they receive |
|---|---|---|
| Intensive exercise & home exercise | Experimental | Intensive exercise group Home exercise group Receives: Other: Intensive exercise; Other: Home exercise |
| Intensive exercise & control | Experimental | Intensive exercise group Control group Receives: Other: Intensive exercise; Other: Control group live as usual |
| Home exercise & control group | Experimental | Home exercise Control group Receives: Other: Home exercise; Other: Control group live as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 36 weeks
Secondary outcomes (1)
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.
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startApr 2011
- Primary completionAug 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Obesity Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jau-Yih Tsauo, PhD, Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001376
- Sponsor's protocol ID
- 201007040R
- Status last verified
- Aug 2019
- First submitted
- 25 Sep 2013
- Last updated
- 4 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Health Promotion Project for Workers at National Taiwan University Hospital
- ClinicalTrials.gov ID
- NCT02001376
- Acronym / sponsor ID
- 201007040R
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 4 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intensive exercise & home exercise | Experimental | Other: Intensive exercise, Other: Home exerciseIntensive exercise group Home exercise group |
| Intensive exercise & control | Experimental | Other: Intensive exercise, Other: Control group live as usualIntensive exercise group Control group |
| Home exercise & control group | Experimental | Other: Home exercise, Other: Control group live as usualHome exercise Control group |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive exerciseThe intensive exercise group will receive moderate aerobic exercise and strengthening exercise three times a week for three months. | Other | Intensive exercise & control, Intensive exercise & home exercise |
| Home exerciseThe home-based exercise group will receive exercise instruction biweekly for three months | Other | Home exercise & control group, Intensive exercise & home exercise |
| Control group live as usualAlso: Control groupControl group means no any intervention for them. The control group who with metabolic syndrome risk factors just live as usual. | Other | Home exercise & control group, Intensive exercise & control |
Primary outcome
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).
1 secondary outcome
All improve fitness status
Time frame: 36 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jau-Yih Tsauo, PhD study chair
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive exercise and Home exercise in people with Abdominal Obesity Metabolic Syndrome and Subjects With Poor Fitness Status, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jau-Yih Tsauo, PhD (886-2-33668130, jytsauo@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All improve fitness status (time frame: 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2019.