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

January 31, 2024 updated by: Watcharasak Chotiyaputta, Mahidol University

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?

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 66000
        • Witchuta Niamsanit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Encourage using pedometer group.
Sarcopenic cirrhotic patient who received pedometer recording and was encouraged to use actively.
Other: Encourage using pedometer
Sarcopenic cirrhotic patient used pedometer recording actively with encourage by care provider or investigator
Device: pedometer
pedometer
Placebo Comparator: Discourage using pedometer group.
Sarcopenic cirrhotic patient who received pedometer recording but without encouraged to use.
Device: pedometer
pedometer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare change of skeletal muscle index (SMI) between encourage using pedometer group and discourage using pedometer group.
Time Frame: 6 months
Change of skeletal muscle index (SMI) between both groups.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients who improved sarcopenia in encourage using pedometer group and discourage using pedometer group.
Time Frame: 6 months
Number of sarcopenic patient improvement in both groups
6 months
Mortality rate in encourage using pedometer group and discourage using pedometer group.
Time Frame: 12 months
Mortality rate in both groups
12 months
The hospital admission
Time Frame: 12 months
hospital admission in both groups
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Witchuta Niamsanit, Gastroenterologist, Siriraj Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

January 31, 2025

Study Completion (Estimated)

July 31, 2025

Study Registration Dates

First Submitted

January 21, 2024

First Submitted That Met QC Criteria

January 29, 2024

First Posted (Actual)

January 30, 2024

Study Record Updates

Last Update Posted (Estimated)

February 2, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Si 085/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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