Daily Step Count Using Pedometer for Sarcopenic Management in Patient With Cirrhosis: Randomized Controlled Trial

Mahidol University70 enrolled

Overview

The goal of clinical trial is to compare using pedometer in sarcopenic cirrhotic patients. The main questions it aims to answer are: 1. Did the encourage using pedometer group had higher change of skeletal muscle index (SMI) than discourage using pedometer group? 2. How many of patients who had sarcopenic improvement in both groups at 6 months after enrollment? 3. What is the mortality rate and hospital admission in both groups at 12 months after enrollment?

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Sarcopenia Cirrhosis, Liver Daily Step Count

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 1\. Age 18 - 75 years old * 2\. Cirrhotic patient with diagnosed sarcopenia * 3\. Patients or caregiver who can write and announce Thai language * 4\. Cirrhotic patient who was post liver transplantation \> 1 year Exclusion Criteria: * 1\. Cirrhosis Child-Turcotte-Pugh (CTP) C \> 10 2. Refractory ascites 3. Decompensated comorbidity: heart failure NYHA III-IV, ESRD with dialysis, COPD Gold D 4. Performance status ECOG 3-4 5. Bone fracture within 4 weeks or limitation of activity 6. Pregnancy and breastfeeding 7. HCC during treatment with TACE or microwave ablation or radiofrequency ablation within 6 months before enrollment 8. Advanced stage malignancy 9. Received chemotherapy 10. Muscle weakness disease 11. Recent cerebrovascular disease within 6 months and motor weakness grade \< II 12. Age 65-75 years old with history of falling \> 2 times/year

Outcomes

Primary Outcomes

To compare change of skeletal muscle index (SMI) between encourage using pedometer group and discourage using pedometer group.

Change of skeletal muscle index (SMI) between both groups.

Time frame: 6 months

Secondary Outcomes

Number of patients who improved sarcopenia in encourage using pedometer group and discourage using pedometer group.

Number of sarcopenic patient improvement in both groups

Time frame: 6 months

Mortality rate in encourage using pedometer group and discourage using pedometer group.

Mortality rate in both groups

Time frame: 12 months

The hospital admission

hospital admission in both groups