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Effects of Yoga on Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT02140203
Recruitment Status : Completed
First Posted : May 16, 2014
Last Update Posted : May 16, 2014
Sponsor:
Collaborator:
The Hong Kong Jockey Club Charities Trust
Information provided by (Responsible Party):
Angus Yu, The Hong Kong Polytechnic University

Brief Summary:
Metabolic syndrome (MetS) is a clustering of cardiovascular risk factors characterizing central obesity, insulin resistance, dyslipidemia and high blood pressure. The concept of MetS represents the pre-cardiovascular and pre-diabetic pathologic conditions, which has been a useful tool in prognosing the development of cardiovascular disease and diabetes mellitus. Importantly, interventions applied at the pre-pathologic stage with MetS would be of great clinical and health significance in achieving better preventive and therapeutic outcomes. Yoga, a mind-body exercise, has been suggested to have beneficial effects on dyslipidemia, hypertension and diabetes. A pilot study has demonstrated the trends in the improvement of metabolic parameters in middle-aged adults with MetS but the findings are inconclusive because of the small sample size and brief yoga follow-up period (i.e., 2-month). In addition to the needs of a better designed randomized controlled trial in studying the beneficial effect of yoga in controlling MetS in middle-aged individuals, the investigation on yoga and MetS in elderly population has been lacking. This is important as the potential use of yoga as lifestyle modification in elderly individuals with MetS will result in significant reduction of the prevalence of cardiovascular disease and diabetes. Thus, this study aims to examine the efficacy of yoga exercise in improving metabolic abnormalities in middle-aged and older adults with MetS. In addition to elderly, middle-aged adults are included in the present investigation because of the idea that cardiovascular diseases and diabetes with aging can be mostly prevented by intervention at the middle-age. A randomized controlled trial with repeated measure design will be conducted to examine the effect of 1-year regular yoga training on the MetS parameters in middle-aged and older individuals who are 30-60 and 60-80 years of age, respectively. Primary outcome measures include waist circumference, systolic/diastolic blood pressure, blood glucose, triglyceride, and lipid cholesterol profile whereas secondary outcome measures include self-reported stress and depression levels. This study is anticipated to provide valuable information in exploring the therapeutic role of yoga in managing MetS. As yoga exercise is an economical regimen which can be easily and readily applied to large scale of target population, it is of hope to be practically useful to relieve the burden on cardiovascular disease and diabetes by introducing yoga lifestyle to the management of MetS.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Other: Yoga Training Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Yoga on Metabolic Abnormalities Outcomes in Middle-Aged and Older Adults With Metabolic Syndrome
Study Start Date : July 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Young Yoga Group
People who are younger than 60 year-old They have received Yoga training in one-year experimental period
Other: Yoga Training
one-year experimental training (three times per week and one hour per session)
Other Name: Hatha Yoga Training
No Intervention: Young Control Group
People who are younger than 60 year-old No Yoga training through out the one-year experimental period
No Intervention: Aged Control Group
People who are equal or older than 60 year-old They have not received any yoga training during the one-year experimental period
Active Comparator: Aged Yoga Group
People who are equal or older than 60 year-old They have received any yoga training during the one-year experimental period
Other: Yoga Training
one-year experimental training (three times per week and one hour per session)
Other Name: Hatha Yoga Training



Primary Outcome Measures :
  1. Change in waist circumference [ Time Frame: Six Months ]
    The operational definition of waist circumference is the measure of circumference at the waist area. This is a commonly used indicator for recognizing central obesity. The waist circumference will be determined by using tape with metric scale. To determine the waist circumference, the upper hip bone will be located and a measuring tape will be placed around the abdomen. The tape measure will be horizontal and the measuring tape will not be snug but without causing compressions on the skin.

  2. Change in systolic/diastolic blood pressure [ Time Frame: Six Months ]
    Resting blood pressure measurement will be performed after the subject has taken 15-minute rest in the laboratory by using an electronic blood pressure monitor. Both the systolic and diastolic blood pressure will be obtained with the cuff over brachial artery region at the level of heart.

  3. Change in blood glucose [ Time Frame: Six Months ]
    Measurements will be performed on the glucose and insulin level in venous blood sample collected after overnight fast. Subjects will be asked to come to the laboratory after an overnight ~10 hours fasting. Before each resting blood sampling, subjects will be requested to sit in a quiet environment for 15 minutes prior to blood collection. Ten ml of venous blood will be drawn from an antecubital vein in the forearm. The blood collection will be performed by a licensed nurse or medical lab technologist. After collection of venous blood sample, blood samples will be dispensed into a lithium heparin plastic tube to prevent coagulation. The remnant whole blood will be centrifuged to obtain plasma samples and stored at -80°C in a freezer before being analyzed for glucose

  4. Change in triglyceride [ Time Frame: Six Months ]
    Ten ml of venous blood will be drawn from an antecubital vein in the forearm. The blood collection will be performed by a licensed nurse or medical lab technologist. After collection of venous blood sample, blood samples will be dispensed into a lithium heparin plastic tube to prevent coagulation. The remnant whole blood will be centrifuged to obtain plasma samples and stored at -80°C in a freezer before being analyzed for triglyceride.

  5. Change in lipoprotein [ Time Frame: Six Months ]
    The blood collection will be performed by a licensed nurse or medical lab technologist. After collection of venous blood sample, blood samples will be dispensed into a lithium heparin plastic tube to prevent coagulation. Measurements will be performed on HDL-C level in the collected venous blood samples.

  6. Change in waist circumference [ Time Frame: One year ]
    The operational definition of waist circumference is the measure of circumference at the waist area. This is a commonly used indicator for recognizing central obesity. The waist circumference will be determined by using tape with metric scale. To determine the waist circumference, the upper hip bone will be located and a measuring tape will be placed around the abdomen. The tape measure will be horizontal and the measuring tape will not be snug but without causing compressions on the skin.

  7. Change in systolic/diastolic pressure [ Time Frame: One year ]
    Resting blood pressure measurement will be performed after the subject has taken 15-minute rest in the laboratory by using an electronic blood pressure monitor. Both the systolic and diastolic blood pressure will be obtained with the cuff over brachial artery region at the level of heart.

  8. Change in blood glucose [ Time Frame: One year ]
    Measurements will be performed on the glucose and insulin level in venous blood sample collected after overnight fast. Subjects will be asked to come to the laboratory after an overnight ~10 hours fasting. Before each resting blood sampling, subjects will be requested to sit in a quiet environment for 15 minutes prior to blood collection. Ten ml of venous blood will be drawn from an antecubital vein in the forearm. The blood collection will be performed by a licensed nurse or medical lab technologist. After collection of venous blood sample, blood samples will be dispensed into a lithium heparin plastic tube to prevent coagulation. The remnant whole blood will be centrifuged to obtain plasma samples and stored at -80°C in a freezer before being analyzed for glucose

  9. Change in triglyceride [ Time Frame: One year ]
    Ten ml of venous blood will be drawn from an antecubital vein in the forearm. The blood collection will be performed by a licensed nurse or medical lab technologist. After collection of venous blood sample, blood samples will be dispensed into a lithium heparin plastic tube to prevent coagulation. The remnant whole blood will be centrifuged to obtain plasma samples and stored at -80°C in a freezer before being analyzed for triglyceride.

  10. Change in lipoprotein [ Time Frame: One year ]
    The blood collection will be performed by a licensed nurse or medical lab technologist. After collection of venous blood sample, blood samples will be dispensed into a lithium heparin plastic tube to prevent coagulation. Measurements will be performed on HDL-C level in the collected venous blood samples.


Secondary Outcome Measures :
  1. Change in self-reported stress and depression levels [ Time Frame: Six Months ]
    Self-reported stress and depression levels are proposed to be the secondary outcome measures because the stress and depression levels could be improved by yoga intervention which might have beneficial effects on MetS parameters indirectly. The indicator of stress level will be adopted to estimate the mental health in this project. The Patton Type A personality questionnaire will be used to examine the stress level. The Center for Epidemiologic Studies Depression Scale (CES-D) will be used to estimate the depression level of the subjects.

  2. Change in Self-reported stress and depression levels [ Time Frame: One year ]
    Self-reported stress and depression levels are proposed to be the secondary outcome measures because the stress and depression levels could be improved by yoga intervention which might have beneficial effects on MetS parameters indirectly. The indicator of stress level will be adopted to estimate the mental health in this project. The Patton Type A personality questionnaire will be used to examine the stress level. The Center for Epidemiologic Studies Depression Scale (CES-D) will be used to estimate the depression level of the subjects.



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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

MetS is defined as having three or more (>= 3) of the following conditions:

  • Central obesity - Waist circumference >= 90 cm (Asian male); 80 cm (Asian female)
  • High blood pressure - Systolic blood pressure/diastolic blood pressure >= 130/85 mmHg or use of hypertension drug
  • Elevated blood glucose - Fasting blood glucose >= 100 mg/dL or use of hyperglycemia drug
  • Elevated blood triglyceride - Blood triglyceride >= 150 mg/dL
  • Reduced HDL-cholesterol - HDL-C <= 40 mg/dL (male); <= 50 mg/dL (female)

Exclusion Criteria:

  • Dementia
  • Mental disorders
  • Severe or acute cardiovascular illnesses
  • Post-stroke,
  • Neuromusculoskeletal illnesses
  • Major orthopaedic diagnosis in the lower back
  • Pelvis or lower extremities
  • Severe rheumatoid arthritis
  • Osteoarthritis
  • Pulmonary illnesses
  • Immobile
  • Wheelchair users
  • Undertaking drug therapy treating metabolic abnormalities
  • Acute medical illness
  • Symptomatic heart disease
  • Symptomatic lung disease
  • Physical conditions not suitable for exercise training, and tobacco users
  • Regular physical activities (>= 3 days per week of moderate exercise intensity >= 30 minutes)

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): NCT02140203


Locations
China
The Hong Kong Polytechnic University
Hong Kong, China, 852
Sponsors and Collaborators
Angus Yu
The Hong Kong Jockey Club Charities Trust
Investigators
Principal Investigator: Parco MF Siu, PHD Associate Professor, Department of Health Technology and Informatics, The Hong Kong Polytechnic University

Responsible Party: Angus Yu, Project Assistant, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT02140203     History of Changes
Other Study ID Numbers: MetsYoga
First Posted: May 16, 2014    Key Record Dates
Last Update Posted: May 16, 2014
Last Verified: May 2014

Keywords provided by Angus Yu, The Hong Kong Polytechnic University:
Metabolic Syndrome
Waist circumference
blood pressure
triglyceride
HDL

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