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

Not Applicable

• Conditions: Sarcopenia; Daily Step Count; Cirrhosis, Liver
• Interventions: Other: Encourage using pedometer; Device: pedometer

• Registration Number: NCT06231420
• Lead Sponsor: Mahidol University

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?

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-21
• Study First Submitted QC: 2024-01-29
• Study First Posted: 2024-01-30
• Last Update Submitted: 2024-01-31
• Study Start: 2024-02-01
• Last Update Posted: 2024-02-02
• Primary Completion: 2025-01-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Encourage using pedometer group.	pedometer	Sarcopenic cirrhotic patient who received pedometer recording and was encouraged to use actively.
Discourage using pedometer group.	pedometer	Sarcopenic cirrhotic patient who received pedometer recording but without encouraged to use.
Encourage using pedometer group.	Encourage using pedometer	Sarcopenic cirrhotic patient who received pedometer recording and was encouraged to use actively.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
The hospital admission	12 months	hospital admission in both groups
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

Trial Locations

Locations (1)

Witchuta Niamsanit; 🇹🇭 Bangkok, Thailand