NCT03107741

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
543

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 5, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 11, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

September 30, 2020

Status Verified

September 1, 2020

Enrollment Period

2.2 years

First QC Date

April 5, 2017

Last Update Submit

September 28, 2020

Conditions

Keywords

Metabolic SyndromeWaist circumferenceBlood pressureTriglycerideHDL cholesterol

Outcome Measures

Primary Outcomes (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.

    Immediately after completion of the 12-week intervention

  • 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.

    6 months after the completion of intervention

Secondary Outcomes (8)

  • Remission of central obesity

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

  • Blood triglyceride

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

  • High density lipoprotein-cholesterol

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

  • Fasting blood glucose

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

  • Systolic blood pressure

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

  • +3 more secondary outcomes

Study Arms (3)

Passive Control

NO INTERVENTION

Subjects in this group will not receive any intervention.

Conventional Exercise

PLACEBO COMPARATOR

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

Other: Conventional Exercise

Tai Chi

ACTIVE COMPARATOR

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

Other: Tai Chi

Interventions

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

Conventional Exercise
Tai ChiOTHER

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

Tai Chi

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Hong Kong Polytechnic University

Hong Kong, 852, Hong Kong

Location

The University of Hong Kong

Hong Kong, 852, Hong Kong

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Parco MF Siu, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

April 5, 2017

First Posted

April 11, 2017

Study Start

February 1, 2016

Primary Completion

May 1, 2018

Study Completion

February 1, 2019

Last Updated

September 30, 2020

Record last verified: 2020-09

Locations