- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03107741
Effectiveness of Tai Chi Training on Metabolic Syndrome
Effectiveness of Tai Chi Training to Alleviate Metabolic Syndrome in Abdominal Obese Older Adults: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PURPOSE/OBJECTIVE: Metabolic syndrome (MetS) is a serious public health problem in Hong Kong and worldwide. Older adults, the age by specific exercise modalities that are suitable for regular participation. This project aims to evaluate the effectiveness of Tai Chi to alleviate MetS in older population.
DESIGN & METHODS: This study is a three-arm assesscer blinded randomized controlled trial. Older adults aged 50 years or above with abdominal obesity will be randomly assigned to passive control, active control and Tai Chi groups. Subjects assigned to Tai Chi and active control groups will receive a 12-week intervention of Tai Chi and generic fitness, respectively. No intervention will be given to the passive control group. Outcome measures including waist circumference, blood pressure, blood glucose, triglyceride and high density lipoprotein-cholesterol will be assessed at baseline, post-intervention and follow-up (6 months after the end of intervention) assessments in all groups.
HYPOTHESES: We hypothesize that: 1) improvements of waist circumference and other indicators of MetS are found in Tai Chi group but not in passive control group and 2) improvements of waist circumference and other indicators of MetS are more profound in Tai Chi group than active control group.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hong Kong, Hong Kong, 852
- The Hong Kong Polytechnic University
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Hong Kong, Hong Kong, 852
- The University of Hong Kong
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Ethnic Chinese
- Abdominal Obese: Meeting the defined criteria of International Diabetes Federation (IDF) and National Cholesterol Education Program (NCEP) for abdominal obesity using Asian-specific cut off (waist circumference ≥ 90 cm for male; ≥ 80 cm for female)
Exclusion Criteria:
- Regularly practice moderate-intensity exercise or tai chi (>3 times a week of >30-min/ session)
- Serious medical and somatic condition that prevent participation in generic fitness/Tai Chi exercise
- Serious chronic diseases known to affect mobility (eg. Neurological diseases, musculoskeletal disorder and autoimmune diseases)
- Under treatment for serious chronic diseases (eg. Cancer treatment)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Passive Control
Subjects in this group will not receive any intervention.
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Placebo Comparator: Conventional Exercise
Subjects in this group will receive three 1-hour conventional exercise training sections per week for 12 weeks
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Subjects in this group will receive three 1-hour conventional exercise training sections per week for 12 weeks
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Active Comparator: Tai Chi
Subjects in this group will receive three 1-hour tai chi training sections per week for 12 weeks
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Subjects in this group will receive three 1-hour tai chi training sections per week for 12 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Waist circumference
Time Frame: Immediately after completion of the 12-week intervention
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Waist circumference will be measured midway between the lowest rib and the superior border of the iliac crest using an inelastic measuring tape on the bare skin to the nearest 0.1 cm.
Measurement will be performed at the end of normal expiration.
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Immediately after completion of the 12-week intervention
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Waist circumference
Time Frame: 6 months after the completion of intervention
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Waist circumference will be measured midway between the lowest rib and the superior border of the iliac crest using an inelastic measuring tape on the bare skin to the nearest 0.1 cm.
Measurement will be performed at the end of normal expiration.
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6 months after the completion of intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Remission of central obesity
Time Frame: Immediately after completion of the 12-week intervention and 6 months after the completion of intervention
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The percentage of subjects that no longer diagnosed with central obesity according to the criterion of International Diabetes Federation (IDF) and National Cholesterol Education Program (NCEP) for abdominal obesity using Asian-specific cut off (waist circumference ≥ 90 cm for male; ≥ 80 cm for female).
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Immediately after completion of the 12-week intervention and 6 months after the completion of intervention
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Blood triglyceride
Time Frame: Immediately after completion of the 12-week intervention and 6 months after the completion of intervention
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Biochemical measurements will be performed in venous blood samples collected after overnight fast.
Subjects will come to our laboratory after an overnight (≥ 8 hours) fasting.
Subjects will sit in a quiet environment for 15 minutes prior to blood collection.
Venous blood will be drawn from an antecubital vein in the forearm by a licensed phlebotomist.
The level of blood triglyceride will be measured by an accredited medical laboratory.
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Immediately after completion of the 12-week intervention and 6 months after the completion of intervention
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High density lipoprotein-cholesterol
Time Frame: Immediately after completion of the 12-week intervention and 6 months after the completion of intervention
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Biochemical measurements will be performed in venous blood samples collected after overnight fast.
Subjects will come to our laboratory after an overnight (≥ 8 hours) fasting.
Subjects will sit in a quiet environment for 15 minutes prior to blood collection.
Venous blood will be drawn from an antecubital vein in the forearm by a licensed phlebotomist.
The level of HDL-cholesterol will be measured by an accredited medical laboratory.
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Immediately after completion of the 12-week intervention and 6 months after the completion of intervention
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Fasting blood glucose
Time Frame: Immediately after completion of the 12-week intervention and 6 months after the completion of intervention
|
Biochemical measurements will be performed in venous blood samples collected after overnight fast.
Subjects will come to our laboratory after an overnight (≥ 8 hours) fasting.
Subjects will sit in a quiet environment for 15 minutes prior to blood collection.
Venous blood will be drawn from an antecubital vein in the forearm by a licensed phlebotomist.
The level of blood glucose will be measured by an accredited medical laboratory.
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Immediately after completion of the 12-week intervention and 6 months after the completion of intervention
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Systolic blood pressure
Time Frame: Immediately after completion of the 12-week intervention and 6 months after the completion of intervention
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Blood pressure measurement will be measured on the right arm after a 5-minute seated rest using the Datascope Accutorr Plus BP Monitor.
Systolic and diastolic blood pressure will be obtained over brachial artery region with the arm supported at heart level using appropriate sized cuff.
The average of two measurements taken within one minute interval will be recorded for analysis.
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Immediately after completion of the 12-week intervention and 6 months after the completion of intervention
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Diastolic blood pressure
Time Frame: Immediately after completion of the 12-week intervention and 6 months after the completion of intervention
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Blood pressure measurement will be measured on the right arm after a 5-minute seated rest using the Datascope Accutorr Plus BP Monitor.
Systolic and diastolic blood pressure will be obtained over brachial artery region with the arm supported at heart level using appropriate sized cuff.
The average of two measurements taken within one minute interval will be recorded for analysis.
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Immediately after completion of the 12-week intervention and 6 months after the completion of intervention
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Bodyweight
Time Frame: Immediately after completion of the 12-week intervention and 6 months after the completion of intervention
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A calibrated electronic digital weighing scale with a capacity from 0.05kg to 150kg (± 0.05kg accuracy) will be used to weigh the subjects.
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Immediately after completion of the 12-week intervention and 6 months after the completion of intervention
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Body mass index
Time Frame: Immediately after completion of the 12-week intervention and 6 months after the completion of intervention
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A calibrated electronic digital weighing scale with a capacity from 0.05kg to 150kg (± 0.05kg accuracy) will be used to weigh the subjects.
A stadiometer (Holtain Ltd., UK) with 200 cm limit and ± 0.01 cm accuracy will be used to measure body height.
The BMI will be calculated from the body weight and height.
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Immediately after completion of the 12-week intervention and 6 months after the completion of intervention
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Parco MF Siu, PhD, The University of Hong Kong
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
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
- Tai Chi and Metabolic Syndrome
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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