Nctid:
NCT06231420
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D008103", "term"=>"Liver Cirrhosis"}, {"id"=>"D055948", "term"=>"Sarcopenia"}, {"id"=>"D005355", "term"=>"Fibrosis"}], "ancestors"=>[{"id"=>"D010335", "term"=>"Pathologic Processes"}, {"id"=>"D008107", "term"=>"Liver Diseases"}, {"id"=>"D004066", "term"=>"Digestive System Diseases"}, {"id"=>"D009133", "term"=>"Muscular Atrophy"}, {"id"=>"D020879", "term"=>"Neuromuscular Manifestations"}, {"id"=>"D009461", "term"=>"Neurologic Manifestations"}, {"id"=>"D009422", "term"=>"Nervous System Diseases"}, {"id"=>"D001284", "term"=>"Atrophy"}, {"id"=>"D020763", "term"=>"Pathological Conditions, Anatomical"}], "browseLeaves"=>[{"id"=>"M11103", "name"=>"Liver Cirrhosis", "asFound"=>"Cirrhosis", "relevance"=>"HIGH"}, {"id"=>"M28396", "name"=>"Sarcopenia", "asFound"=>"Sarcopenia", "relevance"=>"HIGH"}, {"id"=>"M8485", "name"=>"Fibrosis", "asFound"=>"Cirrhosis", "relevance"=>"HIGH"}, {"id"=>"M11107", "name"=>"Liver Diseases", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"M4589", "name"=>"Atrophy", "relevance"=>"LOW"}, {"id"=>"M12090", "name"=>"Muscular Atrophy", "relevance"=>"LOW"}, {"id"=>"M22619", "name"=>"Neuromuscular Manifestations", "relevance"=>"LOW"}, {"id"=>"M12404", "name"=>"Neurologic Manifestations", "relevance"=>"LOW"}, {"id"=>"M22519", "name"=>"Pathological Conditions, Anatomical", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M11110", "name"=>"Liver Extracts", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Hematinics", "abbrev"=>"Hemat"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["PARTICIPANT"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>70}}, "statusModule"=>{"overallStatus"=>"ENROLLING_BY_INVITATION", "startDateStruct"=>{"date"=>"2024-02-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2025-07-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-31", "studyFirstSubmitDate"=>"2024-01-21", "studyFirstSubmitQcDate"=>"2024-01-29", "lastUpdatePostDateStruct"=>{"date"=>"2024-02-02", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-01-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"To compare change of skeletal muscle index (SMI) between encourage using pedometer group and discourage using pedometer group.", "timeFrame"=>"6 months", "description"=>"Change of skeletal muscle index (SMI) between both groups."}], "secondaryOutcomes"=>[{"measure"=>"Number of patients who improved sarcopenia in encourage using pedometer group and discourage using pedometer group.", "timeFrame"=>"6 months", "description"=>"Number of sarcopenic patient improvement in both groups"}, {"measure"=>"Mortality rate in encourage using pedometer group and discourage using pedometer group.", "timeFrame"=>"12 months", "description"=>"Mortality rate in both groups"}, {"measure"=>"The hospital admission", "timeFrame"=>"12 months", "description"=>"hospital admission in both groups"}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Sarcopenia", "Liver cirrhosis", "Daily step count", "Pedometer recording"], "conditions"=>["Sarcopenia", "Cirrhosis, Liver", "Daily Step Count"]}, "referencesModule"=>{"references"=>[{"pmid"=>"32033882", "type"=>"BACKGROUND", "citation"=>"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."}, {"pmid"=>"30312372", "type"=>"BACKGROUND", "citation"=>"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. Erratum In: Age Ageing. 2019 Jul 1;48(4):601. doi: 10.1093/ageing/afz046."}, {"pmid"=>"21893129", "type"=>"BACKGROUND", "citation"=>"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. 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Branched-chain amino acid metabolism. Annu Rev Nutr. 1984;4:409-54. doi: 10.1146/annurev.nu.04.070184.002205. No abstract available."}, {"pmid"=>"24599772", "type"=>"BACKGROUND", "citation"=>"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."}, {"pmid"=>"24768811", "type"=>"BACKGROUND", "citation"=>"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."}, {"pmid"=>"33788206", "type"=>"BACKGROUND", "citation"=>"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."}, {"pmid"=>"27348200", "type"=>"BACKGROUND", "citation"=>"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. 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Low-Cost Consumer-Based Trackers to Measure Physical Activity and Sleep Duration Among Adults in Free-Living Conditions: Validation Study. JMIR Mhealth Uhealth. 2020 May 19;8(5):e16674. doi: 10.2196/16674."}, {"pmid"=>"22018588", "type"=>"BACKGROUND", "citation"=>"Lee PH, Macfarlane DJ, Lam TH, Stewart SM. Validity of the International Physical Activity Questionnaire Short Form (IPAQ-SF): a systematic review. Int J Behav Nutr Phys Act. 2011 Oct 21;8:115. doi: 10.1186/1479-5868-8-115."}, {"pmid"=>"1285753", "type"=>"BACKGROUND", "citation"=>"Brazier JE, Harper R, Jones NM, O'Cathain A, Thomas KJ, Usherwood T, Westlake L. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. BMJ. 1992 Jul 18;305(6846):160-4. doi: 10.1136/bmj.305.6846.160."}, {"pmid"=>"29024353", "type"=>"RESULT", "citation"=>"Duarte-Rojo A, Ruiz-Margain A, Montano-Loza AJ, Macias-Rodriguez RU, Ferrando A, Kim WR. Exercise and physical activity for patients with end-stage liver disease: Improving functional status and sarcopenia while on the transplant waiting list. Liver Transpl. 2018 Jan;24(1):122-139. doi: 10.1002/lt.24958."}, {"pmid"=>"35331941", "type"=>"RESULT", "citation"=>"Lin FP, Bloomer PM, Grubbs RK, Rockette-Wagner B, Tevar AD, Dunn MA, Duarte-Rojo A. Low Daily Step Count Is Associated With a High Risk of Hospital Admission and Death in Community-Dwelling Patients With Cirrhosis. Clin Gastroenterol Hepatol. 2022 Aug;20(8):1813-1820.e2. doi: 10.1016/j.cgh.2022.03.012. Epub 2022 Mar 21."}, {"pmid"=>"33866152", "type"=>"RESULT", "citation"=>"Pino-Ortega J, Gomez-Carmona CD, Rico-Gonzalez M. Accuracy of Xiaomi Mi Band 2.0, 3.0 and 4.0 to measure step count and distance for physical activity and healthcare in adults over 65 years. Gait Posture. 2021 Jun;87:6-10. doi: 10.1016/j.gaitpost.2021.04.015. Epub 2021 Apr 15."}, {"pmid"=>"28894465", "type"=>"RESULT", "citation"=>"Cichoz-Lach H, Michalak A. A Comprehensive Review of Bioelectrical Impedance Analysis and Other Methods in the Assessment of Nutritional Status in Patients with Liver Cirrhosis. Gastroenterol Res Pract. 2017;2017:6765856. doi: 10.1155/2017/6765856. Epub 2017 Aug 13."}]}, "descriptionModule"=>{"briefSummary"=>"The goal of clinical trial is to compare using pedometer in sarcopenic cirrhotic patients. The main questions it aims to answer are:\n\n1. Did the encourage using pedometer group had higher change of skeletal muscle index (SMI) than discourage using pedometer group?\n2. How many of patients who had sarcopenic improvement in both groups at 6 months after enrollment?\n3. What is the mortality rate and hospital admission in both groups at 12 months after enrollment?"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"75 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* 1. Age 18 - 75 years old\n* 2. Cirrhotic patient with diagnosed sarcopenia\n* 3. Patients or caregiver who can write and announce Thai language\n* 4. Cirrhotic patient who was post liver transplantation \\> 1 year\n\nExclusion Criteria:\n\n* 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"}, "identificationModule"=>{"nctId"=>"NCT06231420", "briefTitle"=>"Daily Step Count Using Pedometer for Sarcopenic Management in Patient With Cirrhosis: Randomized Controlled Trial", "organization"=>{"class"=>"OTHER", "fullName"=>"Mahidol University"}, "officialTitle"=>"Daily Step Count Using Pedometer for Sarcopenic Management in Patient With Cirrhosis: Randomized Controlled Trial", "orgStudyIdInfo"=>{"id"=>"Si 085/2023"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"Encourage using pedometer group.", "description"=>"Sarcopenic cirrhotic patient who received pedometer recording and was encouraged to use actively.", "interventionNames"=>["Other: Encourage using pedometer", "Device: pedometer"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"Discourage using pedometer group.", "description"=>"Sarcopenic cirrhotic patient who received pedometer recording but without encouraged to use.", "interventionNames"=>["Device: pedometer"]}], "interventions"=>[{"name"=>"Encourage using pedometer", "type"=>"OTHER", "description"=>"Sarcopenic cirrhotic patient used pedometer recording actively with encourage by care provider or investigator", "armGroupLabels"=>["Encourage using pedometer group."]}, {"name"=>"pedometer", "type"=>"DEVICE", "description"=>"pedometer", "armGroupLabels"=>["Discourage using pedometer group.", "Encourage using pedometer group."]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"66000", "city"=>"Bangkok", "country"=>"Thailand", "facility"=>"Witchuta Niamsanit", "geoPoint"=>{"lat"=>13.75398, "lon"=>100.50144}}], "overallOfficials"=>[{"name"=>"Witchuta Niamsanit, Gastroenterologist", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Siriraj Hospital"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Mahidol University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Associate professor, Faculty of Medicine Siriraj Hospital", "investigatorFullName"=>"Watcharasak Chotiyaputta", "investigatorAffiliation"=>"Mahidol University"}}}}
