Effectiveness of Tai Chi Training on Metabolic Syndrome

September 28, 2020 updated by: Angus Yu

Effectiveness of Tai Chi Training to Alleviate Metabolic Syndrome in Abdominal Obese Older Adults: A Randomized Controlled Trial

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
543

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong, 852
        • The Hong Kong Polytechnic University
      • Hong Kong, Hong Kong, 852
        • The University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Passive Control
Subjects in this group will not receive any intervention.
Placebo Comparator: Conventional Exercise
Subjects in this group will receive three 1-hour conventional exercise training sections per week for 12 weeks
Other: Conventional Exercise
Subjects in this group will receive three 1-hour conventional exercise training sections per week for 12 weeks
Active Comparator: Tai Chi
Subjects in this group will receive three 1-hour tai chi training sections per week for 12 weeks
Other: Tai Chi
Subjects in this group will receive three 1-hour tai chi training sections per week for 12 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Waist circumference
Time Frame: Immediately after completion of the 12-week intervention
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.
Immediately after completion of the 12-week intervention
Waist circumference
Time Frame: 6 months after the completion of intervention
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.
6 months after the completion of intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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).
Immediately after completion of the 12-week intervention and 6 months after the completion of intervention
Blood triglyceride
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 triglyceride will be measured by an accredited medical laboratory.
Immediately after completion of the 12-week intervention and 6 months after the completion of intervention
High density lipoprotein-cholesterol
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 HDL-cholesterol will be measured by an accredited medical laboratory.
Immediately after completion of the 12-week intervention and 6 months after the completion of intervention
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.
Immediately after completion of the 12-week intervention and 6 months after the completion of intervention
Systolic blood pressure
Time Frame: Immediately after completion of the 12-week intervention and 6 months after the completion of intervention
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.
Immediately after completion of the 12-week intervention and 6 months after the completion of intervention
Diastolic blood pressure
Time Frame: Immediately after completion of the 12-week intervention and 6 months after the completion of intervention
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.
Immediately after completion of the 12-week intervention and 6 months after the completion of intervention
Bodyweight
Time Frame: Immediately after completion of the 12-week intervention and 6 months after the completion of intervention
A calibrated electronic digital weighing scale with a capacity from 0.05kg to 150kg (± 0.05kg accuracy) will be used to weigh the subjects.
Immediately after completion of the 12-week intervention and 6 months after the completion of intervention
Body mass index
Time Frame: Immediately after completion of the 12-week intervention and 6 months after the completion of intervention
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.
Immediately after completion of the 12-week intervention and 6 months after the completion of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Angus Yu

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Parco MF Siu, PhD, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 5, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 30, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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