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Effects of Yoga on Metabolic Syndrome

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Yoga Training
Sponsored by
Angus Yu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring Metabolic Syndrome, Waist circumference, blood pressure, triglyceride, HDL

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • The Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

No Intervention

No Intervention

Active Comparator

Arm Label

Young Yoga Group

Young Control Group

Aged Control Group

Aged Yoga Group

Arm Description

People who are younger than 60 year-old They have received Yoga training in one-year experimental period

People who are younger than 60 year-old No Yoga training through out the one-year experimental period

People who are equal or older than 60 year-old They have not received any yoga training during the one-year experimental period

People who are equal or older than 60 year-old They have received any yoga training during the one-year experimental period

Outcomes

Primary Outcome Measures

Change in waist circumference
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.
Change in systolic/diastolic blood pressure
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.
Change in blood glucose
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
Change in triglyceride
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.
Change in lipoprotein
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.
Change in waist circumference
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.
Change in systolic/diastolic pressure
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.
Change in blood glucose
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
Change in triglyceride
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.
Change in lipoprotein
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

Change in self-reported stress and depression levels
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.
Change in Self-reported stress and depression levels
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.

Full Information

First Posted
May 13, 2014
Last Updated
May 14, 2014
Sponsor
Angus Yu
Collaborators
The Hong Kong Jockey Club Charities Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02140203
Brief Title
Effects of Yoga on Metabolic Syndrome
Official Title
Effect of Yoga on Metabolic Abnormalities Outcomes in Middle-Aged and Older Adults With Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Angus Yu
Collaborators
The Hong Kong Jockey Club Charities Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
Metabolic Syndrome, Waist circumference, blood pressure, triglyceride, HDL

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
182 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Young Yoga Group
Arm Type
Active Comparator
Arm Description
People who are younger than 60 year-old They have received Yoga training in one-year experimental period
Arm Title
Young Control Group
Arm Type
No Intervention
Arm Description
People who are younger than 60 year-old No Yoga training through out the one-year experimental period
Arm Title
Aged Control Group
Arm Type
No Intervention
Arm Description
People who are equal or older than 60 year-old They have not received any yoga training during the one-year experimental period
Arm Title
Aged Yoga Group
Arm Type
Active Comparator
Arm Description
People who are equal or older than 60 year-old They have received any yoga training during the one-year experimental period
Intervention Type
Other
Intervention Name(s)
Yoga Training
Other Intervention Name(s)
Hatha Yoga Training
Intervention Description
one-year experimental training (three times per week and one hour per session)
Primary Outcome Measure Information:
Title
Change in waist circumference
Description
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.
Time Frame
Six Months
Title
Change in systolic/diastolic blood pressure
Description
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.
Time Frame
Six Months
Title
Change in blood glucose
Description
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
Time Frame
Six Months
Title
Change in triglyceride
Description
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.
Time Frame
Six Months
Title
Change in lipoprotein
Description
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.
Time Frame
Six Months
Title
Change in waist circumference
Description
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.
Time Frame
One year
Title
Change in systolic/diastolic pressure
Description
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.
Time Frame
One year
Title
Change in blood glucose
Description
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
Time Frame
One year
Title
Change in triglyceride
Description
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.
Time Frame
One year
Title
Change in lipoprotein
Description
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.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Change in self-reported stress and depression levels
Description
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.
Time Frame
Six Months
Title
Change in Self-reported stress and depression levels
Description
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.
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Parco MF Siu, PHD
Organizational Affiliation
Associate Professor, Department of Health Technology and Informatics, The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hong Kong
ZIP/Postal Code
852
Country
China

12. IPD Sharing Statement

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Effects of Yoga on Metabolic Syndrome

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