Sarcopenia Clinical Trial
Official title:
Daily Step Count Using Pedometer for Sarcopenic Management in Patient With Cirrhosis: Randomized Controlled Trial
Verified date | January 2024 |
Source | Mahidol University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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?
Status | Enrolling by invitation |
Enrollment | 70 |
Est. completion date | July 31, 2025 |
Est. primary completion date | January 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Thailand | Witchuta Niamsanit | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Mahidol University |
Thailand,
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* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 6 months | |
Secondary | Number of patients who improved sarcopenia in encourage using pedometer group and discourage using pedometer group. | Number of sarcopenic patient improvement in both groups | 6 months | |
Secondary | Mortality rate in encourage using pedometer group and discourage using pedometer group. | Mortality rate in both groups | 12 months | |
Secondary | The hospital admission | hospital admission in both groups | 12 months |
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