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Effectiveness of Tai Chi Training on Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT03107741
Recruitment Status : Recruiting
First Posted : April 11, 2017
Last Update Posted : April 11, 2017
Sponsor:
Information provided by (Responsible Party):
Angus Yu, The Hong Kong Polytechnic University

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

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Other: Generic Fitness Other: Tai Chi Not Applicable

Detailed Description:

PURPOSE/OBJECTIVE: 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.

DESIGN & METHODS: This study will adopt a three-arm randomized controlled trial with pretest-posttest design. 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 be provided with a 12-weeks program of Tai Chi and generic fitness, respectively. No intervention will be given to the passive control group. Outcome measures including MetS components (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 greater in Tai Chi group than active control group.

MAIN OUTCOME MEASURES: Waist circumference, systolic and diastolic blood pressure, blood glucose, triglyceride and high density lipoprotein-cholesterol

DATA ANALYSIS: Two-way (time x intervention) mixed mode ANOVA with post hoc test.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 390 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness of Tai Chi Training to Alleviate Metabolic Syndrome in Abdominal Obese Older Adults: A Randomized Controlled Trial
Actual Study Start Date : October 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Passive Control
Subjects in this group do not received any intervention.
Placebo Comparator: Generic Fitness
Subjects in this groups will receive three fitness lessons in a week while each session last for 1 hour throughout the 12 weeks experimental period
Other: Generic Fitness
Subjects in this groups will receive three fitness lessons in a week while each session last for 1 hour throughout the 12 weeks experimental period

Active Comparator: Tai Chi
Subjects in this groups will receive three tai chi lessons in a week while each session last for 1 hour throughout the 12 weeks experimental period
Other: Tai Chi
Subjects in this groups will receive three Tai Chi lessons in a week while each session last for 1 hour throughout the 12 weeks experimental period




Primary Outcome Measures :
  1. Waist circumference (Baseline Assessment) [ Time Frame: 0 month ]
    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.

  2. Waist circumference (Post-Intervention Assessment) [ Time Frame: 3 months ]
    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.

  3. Waist circumference (Follow-up Assessment) [ Time Frame: 9 months ]
    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 :
  1. Systolic and diastolic blood pressure (Baseline Assessment) [ Time Frame: 0 month ]
    Blood pressure measurement will be measured on the right arm after 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. Average of two measurements taken with 1-minute interval will be recorded for analysis.

  2. Systolic and diastolic blood pressure (Post-Intervention Assessment) [ Time Frame: 3 months ]
    Blood pressure measurement will be measured on the right arm after 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. Average of two measurements taken with 1-minute interval will be recorded for analysis.

  3. Systolic and diastolic blood pressure (Follow-up Assessment) [ Time Frame: 9 months ]
    Blood pressure measurement will be measured on the right arm after 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. Average of two measurements taken with 1-minute interval will be recorded for analysis.

  4. Fasting blood glucose (Baseline Assessment) [ Time Frame: 0 month ]
    Biochemical measurements will be performed in venous blood sample collected after overnight fast. Subjects will come to laboratory after an overnight ≥ 8 hours fasting. Subjects will sit in a quiet environment for 15-minute prior to blood collection. Venous blood will be drawn from an antecubital vein in the forearm by a licensed phlebotomist. After collection of venous blood, blood samples will be dispensed into a lithium heparin plastic tube to prevent coagulation. The obtain blood samples will be used to measure glucose, triglyceride and HDL-cholesterol levels by an accredited medical laboratory.

  5. Fasting blood glucose (Post-Intervention Assessment) [ Time Frame: 3 month ]
    Biochemical measurements will be performed in venous blood sample collected after overnight fast. Subjects will come to laboratory after an overnight ≥ 8 hours fasting. Subjects will sit in a quiet environment for 15-minute prior to blood collection. Venous blood will be drawn from an antecubital vein in the forearm by a licensed phlebotomist. After collection of venous blood, blood samples will be dispensed into a lithium heparin plastic tube to prevent coagulation. The obtain blood samples will be used to measure glucose, triglyceride and HDL-cholesterol levels by an accredited medical laboratory.

  6. Fasting blood glucose (Follow-up Assessment) [ Time Frame: 9 months ]
    Biochemical measurements will be performed in venous blood sample collected after overnight fast. Subjects will come to laboratory after an overnight ≥ 8 hours fasting. Subjects will sit in a quiet environment for 15-minute prior to blood collection. Venous blood will be drawn from an antecubital vein in the forearm by a licensed phlebotomist. After collection of venous blood, blood samples will be dispensed into a lithium heparin plastic tube to prevent coagulation. The obtain blood samples will be used to measure glucose, triglyceride and HDL-cholesterol levels by an accredited medical laboratory.

  7. Blood triglyceride(Baseline Assessment) [ Time Frame: 0 month ]
    Biochemical measurements will be performed in venous blood sample collected after overnight fast. Subjects will come to laboratory after an overnight ≥ 8 hours fasting. Subjects will sit in a quiet environment for 15-minute prior to blood collection. Venous blood will be drawn from an antecubital vein in the forearm by a licensed phlebotomist. After collection of venous blood, blood samples will be dispensed into a lithium heparin plastic tube to prevent coagulation. The obtain blood samples will be used to measure glucose, triglyceride and HDL-cholesterol levels by an accredited medical laboratory.

  8. Blood triglyceride (Post-Intervention Assessment) [ Time Frame: 3 months ]
    Biochemical measurements will be performed in venous blood sample collected after overnight fast. Subjects will come to laboratory after an overnight ≥ 8 hours fasting. Subjects will sit in a quiet environment for 15-minute prior to blood collection. Venous blood will be drawn from an antecubital vein in the forearm by a licensed phlebotomist. After collection of venous blood, blood samples will be dispensed into a lithium heparin plastic tube to prevent coagulation. The obtain blood samples will be used to measure glucose, triglyceride and HDL-cholesterol levels by an accredited medical laboratory.

  9. Blood triglyceride (Follow-up Assessment) [ Time Frame: 9 months ]
    Biochemical measurements will be performed in venous blood sample collected after overnight fast. Subjects will come to laboratory after an overnight ≥ 8 hours fasting. Subjects will sit in a quiet environment for 15-minute prior to blood collection. Venous blood will be drawn from an antecubital vein in the forearm by a licensed phlebotomist. After collection of venous blood, blood samples will be dispensed into a lithium heparin plastic tube to prevent coagulation. The obtain blood samples will be used to measure glucose, triglyceride and HDL-cholesterol levels by an accredited medical laboratory.

  10. High density lipoprotein-cholesterol (Baseline Assessment) [ Time Frame: 0 month ]
    Biochemical measurements will be performed in venous blood sample collected after overnight fast. Subjects will come to laboratory after an overnight ≥ 8 hours fasting. Subjects will sit in a quiet environment for 15-minute prior to blood collection. Venous blood will be drawn from an antecubital vein in the forearm by a licensed phlebotomist. After collection of venous blood, blood samples will be dispensed into a lithium heparin plastic tube to prevent coagulation. The obtain blood samples will be used to measure glucose, triglyceride and HDL-cholesterol levels by an accredited medical laboratory.

  11. High density lipoprotein-cholesterol (Post-Intervention Assessment) [ Time Frame: 3 months ]
    Biochemical measurements will be performed in venous blood sample collected after overnight fast. Subjects will come to laboratory after an overnight ≥ 8 hours fasting. Subjects will sit in a quiet environment for 15-minute prior to blood collection. Venous blood will be drawn from an antecubital vein in the forearm by a licensed phlebotomist. After collection of venous blood, blood samples will be dispensed into a lithium heparin plastic tube to prevent coagulation. The obtain blood samples will be used to measure glucose, triglyceride and HDL-cholesterol levels by an accredited medical laboratory.

  12. High density lipoprotein-cholesterol (Follow-up Assessment) [ Time Frame: 9 months ]
    Biochemical measurements will be performed in venous blood sample collected after overnight fast. Subjects will come to laboratory after an overnight ≥ 8 hours fasting. Subjects will sit in a quiet environment for 15-minute prior to blood collection. Venous blood will be drawn from an antecubital vein in the forearm by a licensed phlebotomist. After collection of venous blood, blood samples will be dispensed into a lithium heparin plastic tube to prevent coagulation. The obtain blood samples will be used to measure glucose, triglyceride and HDL-cholesterol levels by an accredited medical laboratory.



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ethnic Chinese
  • Abdominal Obese: Fulfill the 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:

  • Serious medical and somatic condition that prevent participation from generic fitness/Tai Chi exercise
  • Serious chronic diseases that known to affect mobility (eg. Neurological disease, musculoskeletal disorder and autoimmune diseases)
  • Under treatment of serious chronic diseases (eg. Cancer treatment)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03107741


Contacts
Layout table for location contacts
Contact: Angus PH Yu, Mphil 34008586 ext 8586 angus.yu@connect.polyu.hk
Contact: Parco MF Siu, PhD 34008593 ext 8593 parco.siu@polyu.edu.hk

Locations
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China
The Hong Kong Polytechnic University Recruiting
Hong Kong, China, 852
Contact: Parco MF Siu, Phd    34008593 ext 8593    parco.siu@polyu.edu.hk   
Contact: Angus PH Yu, Mphil    34008638 ext 8586    angus.yu@connect.polyu.hk   
Principal Investigator: Parco MF Siu, PhD         
Sub-Investigator: Angus PH Yu, Mphil         
The Hong Kong Polytechnic University Recruiting
Hong Kong, China, 852
Contact: Angus PH Yu, PHD    34008586 ext 8586    angus.yu@connect.polyu.hk   
Sponsors and Collaborators
Angus Yu

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Responsible Party: Angus Yu, Research Assistant, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT03107741     History of Changes
Other Study ID Numbers: Tai Chi and Metabolic Syndrome
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017

Keywords provided by Angus Yu, The Hong Kong Polytechnic University:
Metabolic Syndrome
Waist circumference
Blood pressure
Triglyceride
HDL cholesterol

Additional relevant MeSH terms:
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Syndrome
Metabolic Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases