Effects of Yoga on Metabolic Syndrome

NCT ID: NCT02140203

Last Updated: 2014-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2013-08-31

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.

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Young Yoga Group

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

Group Type: ACTIVE_COMPARATOR

Yoga Training

Intervention Type: OTHER

one-year experimental training (three times per week and one hour per session)

Young Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: ACTIVE_COMPARATOR

Yoga Training

Intervention Type: OTHER

one-year experimental training (three times per week and one hour per session)

Interventions

Yoga Training

one-year experimental training (three times per week and one hour per session)

Intervention Type: OTHER

Other Intervention Names

Hatha Yoga Training

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)

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Jockey Club Charities Trust

OTHER

Sponsor Role: collaborator

Angus Yu

OTHER

Sponsor Role: lead

Responsible Party

Angus Yu

Project Assistant

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Parco MF Siu, PHD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor, Department of Health Technology and Informatics, The Hong Kong Polytechnic University

Locations

The Hong Kong Polytechnic University

Hong Kong, , China

Countries

China

Other Identifiers

MetsYoga

Identifier Type: -

Identifier Source: org_study_id