SarcopeniaNCT06231420

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

A study testing Encourage using pedometer and pedometer in people with Sarcopenia and Cirrhosis, Liver, run by Mahidol University at 1 site in Thailand.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Sarcopenia, Cirrhosis, Liver, Daily Step Count
What is being tested?: Encourage using pedometer and pedometer
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 70 participants
Where: 1 siteThailand
Study dates: 1 Feb 2024to 31 Jul 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

Thailand1 site

Witchuta Niamsanit
Bangkok, 66000

Other trials in Thailand

About this study

The goal of clinical trial is to compare using pedometer in sarcopenic cirrhotic patients. The main questions it aims to answer are:

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

Conditions: Sarcopenia, Cirrhosis, Liver, Daily Step Count
Being tested: Encourage using pedometer, pedometer
Keywords: Sarcopenia, Liver cirrhosis, Daily step count, Pedometer recording
Medical subject headings: Sarcopenia, Liver Cirrhosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Encourage using pedometerOther
Sarcopenic cirrhotic patient used pedometer recording actively with encourage by care provider or investigator
pedometerDevice
pedometer

Study groups in NCT06231420
Study group	Role	What they receive
Encourage using pedometer group.	Active comparator	Sarcopenic cirrhotic patient who received pedometer recording and was encouraged to use actively. Receives: Other: Encourage using pedometer; Device: pedometer
Discourage using pedometer group.	Placebo comparator	Sarcopenic cirrhotic patient who received pedometer recording but without encouraged to use. Receives: Device: pedometer

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 months

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 202431 Jul 2025

First posted30 Jan 2024
Study start1 Feb 2024 (estimated)
Primary completion31 Jan 2025 (estimated)
Study completion31 Jul 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (25)Papers the sponsor has linked to this study.
Other trials for SarcopeniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 70 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06231420
Sponsor's protocol ID: Si 085/2023
Status last verified: Jan 2024
First submitted: 21 Jan 2024
Last updated: 2 Feb 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S, Kojima T, Kuzuya M, Lee JSW, Lee SY, Lee WJ, Lee Y, Liang CK, Lim JY, Lim WS, Peng LN, Sugimoto K, Tanaka T, Won CW, Yamada M, Zhang T, Akishita M, Arai H. Asian Working Group for Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment. J Am Med Dir Assoc. 2020 Mar;21(3):300-307.e2. doi: 10.1016/j.jamda.2019.12.012. Epub 2020 Feb 4.
PubMed 32033882
Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
PubMed 30312372
Montano-Loza AJ, Meza-Junco J, Prado CM, Lieffers JR, Baracos VE, Bain VG, Sawyer MB. Muscle wasting is associated with mortality in patients with cirrhosis. Clin Gastroenterol Hepatol. 2012 Feb;10(2):166-73, 173.e1. doi: 10.1016/j.cgh.2011.08.028. Epub 2011 Sep 3.
PubMed 21893129
Kalafateli M, Konstantakis C, Thomopoulos K, Triantos C. Impact of muscle wasting on survival in patients with liver cirrhosis. World J Gastroenterol. 2015 Jun 28;21(24):7357-61. doi: 10.3748/wjg.v21.i24.7357.
PubMed 26139982
Volpi E, Nazemi R, Fujita S. Muscle tissue changes with aging. Curr Opin Clin Nutr Metab Care. 2004 Jul;7(4):405-10. doi: 10.1097/01.mco.0000134362.76653.b2.
PubMed 15192443
Hiraoka A, Michitaka K, Kiguchi D, Izumoto H, Ueki H, Kaneto M, Kitahata S, Aibiki T, Okudaira T, Tomida H, Miyamoto Y, Yamago H, Suga Y, Iwasaki R, Mori K, Miyata H, Tsubouchi E, Kishida M, Ninomiya T, Kohgami S, Hirooka M, Tokumoto Y, Abe M, Matsuura B, Hiasa Y. Efficacy of branched-chain amino acid supplementation and walking exercise for preventing sarcopenia in patients with liver cirrhosis. Eur J Gastroenterol Hepatol. 2017 Dec;29(12):1416-1423. doi: 10.1097/MEG.0000000000000986.
PubMed 29016470
Ismaiel A, Bucsa C, Farcas A, Leucuta DC, Popa SL, Dumitrascu DL. Effects of Branched-Chain Amino Acids on Parameters Evaluating Sarcopenia in Liver Cirrhosis: Systematic Review and Meta-Analysis. Front Nutr. 2022 Jan 27;9:749969. doi: 10.3389/fnut.2022.749969. eCollection 2022.
PubMed 35155535
Konstantis G, Pourzitaki C, Chourdakis M, Kitsikidou E, Germanidis G. Efficacy of branched chain amino acids supplementation in liver cirrhosis: A systematic review and meta-analysis. Clin Nutr. 2022 Jun;41(6):1171-1190. doi: 10.1016/j.clnu.2022.03.027. Epub 2022 Apr 1.
PubMed 35500317
Harper AE, Miller RH, Block KP. Branched-chain amino acid metabolism. Annu Rev Nutr. 1984;4:409-54. doi: 10.1146/annurev.nu.04.070184.002205. No abstract available.
PubMed 6380539
Roman E, Torrades MT, Nadal MJ, Cardenas G, Nieto JC, Vidal S, Bascunana H, Juarez C, Guarner C, Cordoba J, Soriano G. Randomized pilot study: effects of an exercise programme and leucine supplementation in patients with cirrhosis. Dig Dis Sci. 2014 Aug;59(8):1966-75. doi: 10.1007/s10620-014-3086-6. Epub 2014 Mar 6.
PubMed 24599772
Zenith L, Meena N, Ramadi A, Yavari M, Harvey A, Carbonneau M, Ma M, Abraldes JG, Paterson I, Haykowsky MJ, Tandon P. Eight weeks of exercise training increases aerobic capacity and muscle mass and reduces fatigue in patients with cirrhosis. Clin Gastroenterol Hepatol. 2014 Nov;12(11):1920-6.e2. doi: 10.1016/j.cgh.2014.04.016. Epub 2014 Apr 24.
PubMed 24768811
Dunn MA, Kappus MR, Bloomer PM, Duarte-Rojo A, Josbeno DA, Jakicic JM. Wearables, Physical Activity, and Exercise Testing in Liver Disease. Semin Liver Dis. 2021 May;41(2):128-135. doi: 10.1055/s-0040-1716564. Epub 2021 Jan 14.
PubMed 33788206
Dunn MA, Josbeno DA, Schmotzer AR, Tevar AD, DiMartini AF, Landsittel DP, Delitto A. The gap between clinically assessed physical performance and objective physical activity in liver transplant candidates. Liver Transpl. 2016 Oct;22(10):1324-32. doi: 10.1002/lt.24506.
PubMed 27348200
Ross R, Blair SN, Arena R, Church TS, Despres JP, Franklin BA, Haskell WL, Kaminsky LA, Levine BD, Lavie CJ, Myers J, Niebauer J, Sallis R, Sawada SS, Sui X, Wisloff U; American Heart Association Physical Activity Committee of the Council on Lifestyle and Cardiometabolic Health; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Council on Cardiovascular and Stroke Nursing; Council on Functional Genomics and Translational Biology; Stroke Council. Importance of Assessing Cardiorespiratory Fitness in Clinical Practice: A Case for Fitness as a Clinical Vital Sign: A Scientific Statement From the American Heart Association. Circulation. 2016 Dec 13;134(24):e653-e699. doi: 10.1161/CIR.0000000000000461. Epub 2016 Nov 21.
PubMed 27881567
Singh Tejavath A, Mathur A, Nathiya D, Singh P, Raj P, Suman S, Mundada PR, Atif S, Rai RR, Tomar BS. Impact of Branched Chain Amino Acid on Muscle Mass, Muscle Strength, Physical Performance, Combined Survival, and Maintenance of Liver Function Changes in Laboratory and Prognostic Markers on Sarcopenic Patients With Liver Cirrhosis (BCAAS Study): A Randomized Clinical Trial. Front Nutr. 2021 Sep 22;8:715795. doi: 10.3389/fnut.2021.715795. eCollection 2021.
PubMed 34631765

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Daily Step Count Using Pedometer for Sarcopenic Management in Patient With Cirrhosis: Randomized Controlled Trial
ClinicalTrials.gov ID: NCT06231420
Acronym / sponsor ID: Si 085/2023
Conditions: Sarcopenia, Cirrhosis, Liver, Daily Step Count
Keywords: Sarcopenia, Liver cirrhosis, Daily step count, Pedometer recording
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 70 participants (estimated)
Lead sponsor: Mahidol UniversityUniversity, hospital or other
Study start: 1 Feb 2024 (estimated)
Primary completion: 31 Jan 2025 (estimated)
Study completion: 31 Jul 2025 (estimated)
First posted: 30 Jan 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The goal of clinical trial is to compare using pedometer in sarcopenic cirrhotic patients. The main questions it aims to answer are:

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Encourage using pedometer group.	Active comparator	Other: Encourage using pedometer, Device: pedometerSarcopenic cirrhotic patient who received pedometer recording and was encouraged to use actively.
Discourage using pedometer group.	Placebo comparator	Device: pedometerSarcopenic cirrhotic patient who received pedometer recording but without encouraged to use.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Encourage using pedometerSarcopenic cirrhotic patient used pedometer recording actively with encourage by care provider or investigator	Other	Encourage using pedometer group.
pedometerpedometer	Device	Discourage using pedometer group., Encourage using pedometer group.

Primary outcome

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.

3 secondary outcomes

Number of patients who improved sarcopenia in encourage using pedometer group and discourage using pedometer group.
Time frame: 6 months
Mortality rate in encourage using pedometer group and discourage using pedometer group.
Time frame: 12 months
The hospital admission
Time frame: 12 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
Background: PubMed 32033882Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S, Kojima T, Kuzuya M, Lee JSW, Lee SY, Lee WJ, Lee Y, Liang CK, Lim JY, Lim WS, Peng LN, Sugimoto K, Tanaka T, Won CW, Yamada M, Zhang T, Akishita M, Arai H. Asian Working Group for Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment. J Am Med Dir Assoc. 2020 Mar;21(3):300-307.e2. doi: 10.1016/j.jamda.2019.12.012. Epub 2020 Feb 4.
Background: PubMed 30312372Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
Background: PubMed 21893129Montano-Loza AJ, Meza-Junco J, Prado CM, Lieffers JR, Baracos VE, Bain VG, Sawyer MB. Muscle wasting is associated with mortality in patients with cirrhosis. Clin Gastroenterol Hepatol. 2012 Feb;10(2):166-73, 173.e1. doi: 10.1016/j.cgh.2011.08.028. Epub 2011 Sep 3.
Background: PubMed 26139982Kalafateli M, Konstantakis C, Thomopoulos K, Triantos C. Impact of muscle wasting on survival in patients with liver cirrhosis. World J Gastroenterol. 2015 Jun 28;21(24):7357-61. doi: 10.3748/wjg.v21.i24.7357.
Background: PubMed 15192443Volpi E, Nazemi R, Fujita S. Muscle tissue changes with aging. Curr Opin Clin Nutr Metab Care. 2004 Jul;7(4):405-10. doi: 10.1097/01.mco.0000134362.76653.b2.
Background: PubMed 29016470Hiraoka A, Michitaka K, Kiguchi D, Izumoto H, Ueki H, Kaneto M, Kitahata S, Aibiki T, Okudaira T, Tomida H, Miyamoto Y, Yamago H, Suga Y, Iwasaki R, Mori K, Miyata H, Tsubouchi E, Kishida M, Ninomiya T, Kohgami S, Hirooka M, Tokumoto Y, Abe M, Matsuura B, Hiasa Y. Efficacy of branched-chain amino acid supplementation and walking exercise for preventing sarcopenia in patients with liver cirrhosis. Eur J Gastroenterol Hepatol. 2017 Dec;29(12):1416-1423. doi: 10.1097/MEG.0000000000000986.
Background: PubMed 35155535Ismaiel A, Bucsa C, Farcas A, Leucuta DC, Popa SL, Dumitrascu DL. Effects of Branched-Chain Amino Acids on Parameters Evaluating Sarcopenia in Liver Cirrhosis: Systematic Review and Meta-Analysis. Front Nutr. 2022 Jan 27;9:749969. doi: 10.3389/fnut.2022.749969. eCollection 2022.
Background: PubMed 35500317Konstantis G, Pourzitaki C, Chourdakis M, Kitsikidou E, Germanidis G. Efficacy of branched chain amino acids supplementation in liver cirrhosis: A systematic review and meta-analysis. Clin Nutr. 2022 Jun;41(6):1171-1190. doi: 10.1016/j.clnu.2022.03.027. Epub 2022 Apr 1.
Background: PubMed 6380539Harper AE, Miller RH, Block KP. Branched-chain amino acid metabolism. Annu Rev Nutr. 1984;4:409-54. doi: 10.1146/annurev.nu.04.070184.002205. No abstract available.
Background: PubMed 24599772Roman E, Torrades MT, Nadal MJ, Cardenas G, Nieto JC, Vidal S, Bascunana H, Juarez C, Guarner C, Cordoba J, Soriano G. Randomized pilot study: effects of an exercise programme and leucine supplementation in patients with cirrhosis. Dig Dis Sci. 2014 Aug;59(8):1966-75. doi: 10.1007/s10620-014-3086-6. Epub 2014 Mar 6.
Background: PubMed 24768811Zenith L, Meena N, Ramadi A, Yavari M, Harvey A, Carbonneau M, Ma M, Abraldes JG, Paterson I, Haykowsky MJ, Tandon P. Eight weeks of exercise training increases aerobic capacity and muscle mass and reduces fatigue in patients with cirrhosis. Clin Gastroenterol Hepatol. 2014 Nov;12(11):1920-6.e2. doi: 10.1016/j.cgh.2014.04.016. Epub 2014 Apr 24.
Background: PubMed 33788206Dunn MA, Kappus MR, Bloomer PM, Duarte-Rojo A, Josbeno DA, Jakicic JM. Wearables, Physical Activity, and Exercise Testing in Liver Disease. Semin Liver Dis. 2021 May;41(2):128-135. doi: 10.1055/s-0040-1716564. Epub 2021 Jan 14.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Witchuta Niamsanit, Gastroenterologist principal investigator

Siriraj Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Encourage using pedometer and pedometer in people with Sarcopenia and Cirrhosis, Liver, run by Mahidol University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To compare change of skeletal muscle index (SMI) between encourage using pedometer group and discourage using pedometer group. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06231420, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024.