Clinical trial NCT06231420: Daily Step Count Using Pedometer for Sarcopenic Management in Patient With Cirrhosis: Randomized Controlled Trial
Official title: Daily Step Count Using Pedometer for Sarcopenic Management in Patient With Cirrhosis: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Sarcopenia
Cirrhosis, Liver
Daily Step Count
Keywords: Sarcopenia
Liver cirrhosis
Daily step count
Pedometer recording
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?


Eligibility criteria: 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

Primary outcomes:
measure: To compare change of skeletal muscle index (SMI) between encourage using pedometer group and discourage using pedometer group.
timeFrame: 6 months
Secondary outcomes:
measure: Number of patients who improved sarcopenia in encourage using pedometer group and discourage using pedometer group.
timeFrame: 6 months
measure: Mortality rate in encourage using pedometer group and discourage using pedometer group.
timeFrame: 12 months
measure: The hospital admission
timeFrame: 12 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Witchuta Niamsanit
Study officials:
affiliation: Siriraj Hospital
name: Witchuta Niamsanit, Gastroenterologist
role: PRINCIPAL_INVESTIGATOR
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