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To compare the improvement in liver disease activity in patients with fatty liver disease using lifestyle intervention in form of Yoga and Exercise

Phase 3
Conditions
Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
Registration Number
CTRI/2024/01/061008
Lead Sponsor
Postgraduate Institute of Medical Education and Research
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1)Patients with MASLD: defined by the presence of hepatic steatosis on ultrasound or using CAP parameters (of Fibroscan) together with the presence of at least one of five cardiometabolic criteria after ruling other causes of hepatic steatosis.

2)Overweight and obese patients as per Asia-Pacific criteria (BMI = 23 and = 25Kg/m2) respectively.

3)All patients must be on stable doses of medical therapy for hypertension or diabetes for atleast 6 weeks before the study start date.

4)Be willing and able to participate in the full program.

5)Be willing and able to functionally participate in all activities set as part of the intervention.

6)Be able to complete all day-to-day activities and instrumental activities of daily living independently, completely without assistance from others.

7)Consent to participate in study.

Exclusion Criteria

1)Patients who are not willing to give consent for the study.

2)Patients who will not be able to carry out yoga and exercise protocol safely, recent fall or > 3 falls in a year, recent hospitalization in 1 month, and those who fail to give consent will be excluded.

3)The patients with severe cardio-pulmonary disease, coronary artery disease, cardiomyopathy, severe musculoskeletal disease, neuropsychiatric disease, history of cardiovascular accident, active malignancy, hepatocellular carcinoma and, the end-stage renal disease.

4)Patients with decompensated cirrhosis or post liver transplant patients

5)Pregnant, lactating women

6)Patients having prior study enrolment or enrolment in another conflicting study within past 3 months.

7)Patients taking weight loss drugs or oral antidiabetic medications (GLP-1 analogues and glitazones) or any pharmacotherapy for NASH (Vitamin E and Saroglitazar).

8)Any patient not meeting any part of the inclusion criteria

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Effectiveness of yoga in improving the hepatic steatosis in patients with MASLD in comparison to standard of careTimepoint: 6 months
Secondary Outcome Measures
NameTimeMethod
Effectiveness of yoga in decreasing the body weight, BMI, central obesity in patients with MASLD in comparison to standard of care.Timepoint: 6 months;Effectiveness of yoga in improving liver variables (inflammation, fibrosis) and metabolic variables (dyslipidemia, hyperglycemia, insulin resistance) in patients with MASLD in comparison to standard of care.Timepoint: 6 months;Effectiveness of yoga in improving the sarcopenic obesity and frailty in patients with MASLD in comparison to standard of care.Timepoint: 6 months
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