AzTrials
AzTrials

Metabolic SyndromeNCT03107741

Effectiveness of Tai Chi Training on Metabolic Syndrome

A study testing Conventional Exercise and Tai Chi in people with Metabolic Syndrome, run by Angus Yu at 2 sites in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Metabolic Syndrome
What is being tested?
Conventional Exercise and Tai Chi
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
543 participants
Where
2 sitesHong Kong
Study dates
Feb 2016to Feb 2019
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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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)

Trial locations and contacts

2 sites in 1 country.

Hong Kong2 sites

  • The Hong Kong Polytechnic University

    Hong Kong, 852

  • The University of Hong Kong

    Hong Kong, 852

Other trials in Hong Kong

About this study

Official title: 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

Read the 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.

Being tested
Conventional Exercise, Tai Chi
Keywords
Metabolic Syndrome, Waist circumference, Blood pressure, Triglyceride, HDL cholesterol
Medical subject headings
Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conventional ExerciseOther

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

  • Tai ChiOther

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

Study groups in NCT03107741
Study groupRoleWhat they receive
Passive ControlNo interventionSubjects in this group will not receive any intervention.
Conventional ExercisePlacebo comparatorSubjects in this group will receive three 1-hour conventional exercise training sections per week for 12 weeks
Receives: Other: Conventional Exercise
Tai ChiActive comparatorSubjects in this group will receive three 1-hour tai chi training sections per week for 12 weeks
Receives: Other: Tai Chi

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Immediately after completion of the 12-week intervention

  2. 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.

    Measured: 6 months after the completion of intervention

Secondary outcomes (8)

  1. 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).

    Measured: Immediately after completion of the 12-week intervention and 6 months after the completion of intervention

  2. 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.

    Measured: Immediately after completion of the 12-week intervention and 6 months after the completion of intervention

  3. 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.

    Measured: Immediately after completion of the 12-week intervention and 6 months after the completion of intervention

  4. 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.

    Measured: Immediately after completion of the 12-week intervention and 6 months after the completion of intervention

  5. 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.

    Measured: Immediately after completion of the 12-week intervention and 6 months after the completion of intervention

  6. 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.

    Measured: Immediately after completion of the 12-week intervention and 6 months after the completion of intervention

  7. 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.

    Measured: Immediately after completion of the 12-week intervention and 6 months after the completion of intervention

  8. 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.

    Measured: Immediately after completion of the 12-week intervention and 6 months after the completion of intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2017
  2. Study startFeb 2016
  3. Primary completionMay 2018
  4. Study completionFeb 2019

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
543 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03107741
Sponsor's protocol ID
Tai Chi and Metabolic Syndrome
Status last verified
Sep 2020
First submitted
5 Apr 2017
Last updated
30 Sep 2020
Results posted
No

Publications

  • 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.

    PubMed 34058100

Questions about this trial

What is this clinical trial studying?

A study testing Conventional Exercise and Tai Chi in people with Metabolic Syndrome, run by Angus Yu at 2 sites in Hong Kong.

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 4 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: finished, as of the sponsor's last update on 30 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Hong Kong. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Waist circumference (time frame: Immediately after completion of the 12-week intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03107741, which also lists 1 linked publication.

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 30 Sep 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in