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Effectiveness of Tai Chi Training on Metabolic Syndrome

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Conventional Exercise
Tai Chi
Sponsored by
Angus Yu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring Metabolic Syndrome, Waist circumference, Blood pressure, Triglyceride, HDL cholesterol

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • The Hong Kong Polytechnic University
  • The University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Placebo Comparator

Active Comparator

Arm Label

Passive Control

Conventional Exercise

Tai Chi

Arm Description

Subjects in this group will not receive any intervention.

Subjects in this group will receive three 1-hour conventional exercise training sections per week for 12 weeks

Subjects in this group will receive three 1-hour tai chi training sections per week for 12 weeks

Outcomes

Primary Outcome Measures

Waist circumference
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.
Waist circumference
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.

Secondary Outcome Measures

Remission of central obesity
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).
Blood triglyceride
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.
High density lipoprotein-cholesterol
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.
Fasting blood glucose
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.
Systolic blood pressure
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.
Diastolic blood pressure
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.
Bodyweight
A calibrated electronic digital weighing scale with a capacity from 0.05kg to 150kg (± 0.05kg accuracy) will be used to weigh the subjects.
Body mass index
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.

Full Information

First Posted
April 5, 2017
Last Updated
September 28, 2020
Sponsor
Angus Yu
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1. Study Identification

Unique Protocol Identification Number
NCT03107741
Brief Title
Effectiveness of Tai Chi Training on Metabolic Syndrome
Official Title
Effectiveness of Tai Chi Training to Alleviate Metabolic Syndrome in Abdominal Obese Older Adults: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
February 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Angus Yu

4. Oversight

5. Study Description

Brief Summary
Metabolic syndrome (MetS) is a serious public health problem in Hong Kong and worldwide. Older adults, the age group with the highest prevalence of MetS, may prefer specific exercise modalities that are suitable for their regular participation to manage MetS. This project aims to evaluate the effectiveness of Tai Chi, a very suitable exercise for older adults, to alleviate MetS in older population
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Metabolic Syndrome, Waist circumference, Blood pressure, Triglyceride, HDL cholesterol

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
543 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Passive Control
Arm Type
No Intervention
Arm Description
Subjects in this group will not receive any intervention.
Arm Title
Conventional Exercise
Arm Type
Placebo Comparator
Arm Description
Subjects in this group will receive three 1-hour conventional exercise training sections per week for 12 weeks
Arm Title
Tai Chi
Arm Type
Active Comparator
Arm Description
Subjects in this group will receive three 1-hour tai chi training sections per week for 12 weeks
Intervention Type
Other
Intervention Name(s)
Conventional Exercise
Intervention Description
Subjects in this group will receive three 1-hour conventional exercise training sections per week for 12 weeks
Intervention Type
Other
Intervention Name(s)
Tai Chi
Intervention Description
Subjects in this group will receive three 1-hour tai chi training sections per week for 12 weeks
Primary Outcome Measure Information:
Title
Waist circumference
Description
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.
Time Frame
Immediately after completion of the 12-week intervention
Title
Waist circumference
Description
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.
Time Frame
6 months after the completion of intervention
Secondary Outcome Measure Information:
Title
Remission of central obesity
Description
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).
Time Frame
Immediately after completion of the 12-week intervention and 6 months after the completion of intervention
Title
Blood triglyceride
Description
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.
Time Frame
Immediately after completion of the 12-week intervention and 6 months after the completion of intervention
Title
High density lipoprotein-cholesterol
Description
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.
Time Frame
Immediately after completion of the 12-week intervention and 6 months after the completion of intervention
Title
Fasting blood glucose
Description
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.
Time Frame
Immediately after completion of the 12-week intervention and 6 months after the completion of intervention
Title
Systolic blood pressure
Description
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.
Time Frame
Immediately after completion of the 12-week intervention and 6 months after the completion of intervention
Title
Diastolic blood pressure
Description
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.
Time Frame
Immediately after completion of the 12-week intervention and 6 months after the completion of intervention
Title
Bodyweight
Description
A calibrated electronic digital weighing scale with a capacity from 0.05kg to 150kg (± 0.05kg accuracy) will be used to weigh the subjects.
Time Frame
Immediately after completion of the 12-week intervention and 6 months after the completion of intervention
Title
Body mass index
Description
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.
Time Frame
Immediately after completion of the 12-week intervention and 6 months after the completion of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Parco MF Siu, PhD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hong Kong
ZIP/Postal Code
852
Country
Hong Kong
Facility Name
The University of Hong Kong
City
Hong Kong
ZIP/Postal Code
852
Country
Hong Kong

12. IPD Sharing Statement

Citations:
PubMed Identifier
34058100
Citation
Siu PM, Yu AP, Chin EC, Yu DS, Hui SS, Woo J, Fong DY, Wei GX, Irwin MR. Effects of Tai Chi or Conventional Exercise on Central Obesity in Middle-Aged and Older Adults : A Three-Group Randomized Controlled Trial. Ann Intern Med. 2021 Aug;174(8):1050-1057. doi: 10.7326/M20-7014. Epub 2021 Jun 1.
Results Reference
derived

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Effectiveness of Tai Chi Training on Metabolic Syndrome

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