Cirrhosis, Liver, Daily Step Count, Sarcopenia
Conditions
Keywords
Sarcopenia, Liver cirrhosis, Daily step count, Pedometer recording
Brief summary
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?
Interventions
Sarcopenic cirrhotic patient used pedometer recording actively with encourage by care provider or investigator
DEVICEpedometer
pedometer
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To compare change of skeletal muscle index (SMI) between encourage using pedometer group and discourage using pedometer group. | 6 months | Change of skeletal muscle index (SMI) between both groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients who improved sarcopenia in encourage using pedometer group and discourage using pedometer group. | 6 months | Number of sarcopenic patient improvement in both groups |
| Mortality rate in encourage using pedometer group and discourage using pedometer group. | 12 months | Mortality rate in both groups |
| The hospital admission | 12 months | hospital admission in both groups |
Countries
Thailand
Outcome results
None listed