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

Mahidol University

Status: Invitation-only

Conditions: Cirrhosis, Liver; Daily Step Count; Sarcopenia

Treatments: Other: Encourage using pedometer; Device: pedometer

Study type: Interventional

Funder types: Other

Identifiers

NCT06231420

Si 085/2023

Details and patient eligibility

About

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?

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups, including a placebo group

Encourage using pedometer group.

Active Comparator group

Description:

Sarcopenic cirrhotic patient who received pedometer recording and was encouraged to use actively.

Treatment:

Device: pedometer

Other: Encourage using pedometer

Discourage using pedometer group.

Placebo Comparator group

Description:

Sarcopenic cirrhotic patient who received pedometer recording but without encouraged to use.

Treatment:

Device: pedometer