Health Condition 1: K74- Fibrosis and cirrhosis of liver
Conditions
Interventions
Intervention1: Nutrition therapy: Home based intensive Nutrition therapy. 6 months.
Control Intervention1: Medical Management: Standard Medical Therapy. 6 months.
Sponsors
Postgraduate Institute of Medical Education and Research
Eligibility
Inclusion criteria
Inclusion criteria: A.Age >= 18 years B.Diagnosis of cirrhosis confirmed by clinical, biochemical, compatible radiology, histology C.Presence of frailty and sarcopenia
Exclusion criteria
Exclusion criteria: A.Patients with CTP score more than 10 Obese patient (BMI >25kg/m2) B.Patients with active malignancy, hepatocellular carcinoma and, the end-stage renal disease will be excluded from the study. C.Patients having prior study enrolment or enrolment in another conflicting study will be excluded. D.Patients, who are not willing to participate in the study will be excluded. E.Patients who are participating in other clinical trials within past 3 months. F.Patients who has an active evidence of infection G.Patients who had acute organic brain disease in the past 6 months H.Patients who has severe hemodynamic instability, serious heart disease, severe bradycardia or tachycardia at rest I.Patients having renal failure (creatinine clearance rate J.Patients who are not able to perform the strength exercise; severe cognitive impairment (Mini-Mental State Examination <=17), overt hepatic encephalopathy or patients who had physical disability.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A.To see the effect of home-based intensive nutrition therapy on frailty scores as measured by the Clinical frailty scale (CFS), (b) Fried frailty criteria (FFC), (c) Short physical performance battery (SPPB), and Liver Frailty Index (LFI). B.To see the changes in prognostic scores (CTP, MELD).Timepoint: Enrolment- 6 months Follow Up-Weekly for First month Monthly for 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Unplanned Hospitalisation and death and need of Liver transplantTimepoint: Improvement in BMI,Mid arm circumference, Mid arm muscle circumference, Skeletal Muscle Index at 3 and 6 month follow up | — |
Countries
India
Contacts
Public ContactSUNIL TANEJA
PGIMER,Chandigarh
Outcome results
None listed