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

NCT06231420 | Unknown DMC

• 1 other identifier: Si 085/2023
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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. 1.Did the encourage using pedometer group had higher change of skeletal muscle index (SMI) than discourage using pedometer group?
2. 2.How many of patients who had sarcopenic improvement in both groups at 6 months after enrollment?
3. 3.What is the mortality rate and hospital admission in both groups at 12 months after enrollment?

Conditions

Sarcopenia; Cirrhosis, Liver; Daily Step Count

Keywords

Sarcopenia; Liver cirrhosis; Daily step count; Pedometer recording

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of patients who improved sarcopenia in encourage using pedometer group and discourage using pedometer group.

  6 months

• Mortality rate in encourage using pedometer group and discourage using pedometer group.

  12 months

• The hospital admission

  12 months

Study Arms (2)

Encourage using pedometer group.

ACTIVE COMPARATOR

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

Other: Encourage using pedometer; Device: pedometer

Discourage using pedometer group.

PLACEBO COMPARATOR

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

Device: pedometer

Interventions

Encourage using pedometer OTHER

Sarcopenic cirrhotic patient used pedometer recording actively with encourage by care provider or investigator

Encourage using pedometer group.

pedometer DEVICE

pedometer

Discourage using pedometer group.; Encourage using pedometer group.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age 18 - 75 years old
• \. Cirrhotic patient with diagnosed sarcopenia
• \. Patients or caregiver who can write and announce Thai language
• \. Cirrhotic patient who was post liver transplantation \> 1 year

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Witchuta Niamsanit

Bangkok, 66000, Thailand

Location

Related Publications (25)

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MeSH Terms

Conditions

Sarcopenia; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes

Study Officials

• Witchuta Niamsanit, Gastroenterologist

  Siriraj Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, Faculty of Medicine Siriraj Hospital

Study Record Dates

• First Submitted: January 21, 2024
• First Posted: January 30, 2024
• Study Start: February 1, 2024
• Primary Completion: January 31, 2025
• Study Completion: July 31, 2025
• Last Updated: February 2, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)