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

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06231420
• Other study ID #: Si 085/2023
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: July 31, 2025

Study information

• Verified date: January 2024
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cirrhosis, Liver
• Fibrosis
• Liver Cirrhosis
• Sarcopenia

Intervention

Other:
• Encourage using pedometer
Sarcopenic cirrhotic patient used pedometer recording actively with encourage by care provider or investigator

Device:
• pedometer
pedometer

Locations

Country	Name	City	State
Thailand	Witchuta Niamsanit	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (25)

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* Note: There are 25 references in all — Click here to view all references

Outcome

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