Effect Of 12-Week Yogic Breathing on Risk Factors Of CVD In Adults With Metabolic Syndrome: A Randomised Controlled Trial

Phase 2

Conditions: Health Condition 1: E888- Other specified metabolic disorders

Registration Number: CTRI/2023/08/056540

Lead Sponsor: ot available

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.) Participants must be willing to give written consent and willing to comply with study protocol.

2.) Individuals diagnosed with MetS as per Joint Interim Statement (JIS), 2009, Criteria for the Clinical Diagnosis of MetS (Alberti, 2009):

a.) hypertension, greater than or equal to 130/85 mmHg or use of hypertension drug,

b.) reduced high-density lipoprotein cholesterol (HDL-C) of less than or equal to 40 mg/dL in males, 50 mg/dL in females or drug treatment for reduced HDL-C,

c.) elevated triglycerides greater than or equal to 150 mg/dL, or drug treatment for elevated TG,

d.) elevated fasting plasma glucose (FPG) greater than or equal to mg/dL or drug treatment for elevated glucose,

e.) abdominal obesity, Waist circumference greater than or equal to 90 cm for male; 80 cm for female (for Asians)

Exclusion Criteria

1.) Pregnant women,

2.) Alcoholism (will be assessed with AUDIT questionnaire, individuals who score more than 15 will be excluded) and smoking,

3.) Uncontrolled T2DM and/ or hypertension,

4.) Individuals diagnosed with severe psychiatric disorders like severe depression, anxiety, PTSD (self reported using the screening form),

5.) Any other major comorbidities like Post-stroke, Neuromusculoskeletal illnesses, Major orthopaedic diagnosis in the lower back, Pelvis or lower extremities, Pulmonary illnesses, Symptomatic heart disease, Symptomatic lung disease, chronic kidney disease (self reported using the screening form)

6.) Regular use of nonsteroidal anti-inflammatory drugs and antioxidant supplements,

7.) Regular Yoga(asanas/pranayama/meditation) practitioners (in the past 6 months)

8.) Individuals practising intense level physical activity (IPAQ questionnaire)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.) Perceived Stress levels <br/ ><br>2.) Blood Pressure (systolic/diastolic(mmHg) <br/ ><br>3.) Serum Lipoprotein(a)Timepoint: 0 day and 12 weeks.

Secondary Outcome Measures

Name	Time	Method
Self-Regulation of Eating Behaviour, Pittsburgh sleep quality index(Questionnaires), TG, HDL- C, FBS, Hba1c, hsCRP (assessed using automated analyser), Superoxide dismutase(SOD), OxLDL, FGF-21(ELISA kits), ECG/HRV.Timepoint: 0 day & 12 weeks.