Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-01-07 @ 3:11 AM
Study NCT ID:
NCT03299504
Status:
COMPLETED
Last Update Posted:
2018-08-24
First Post:
2017-09-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Factors Predicting Success in Lung Transplant Recipients Who Have Undergone Intensive Post-operative Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-23', 'studyFirstSubmitDate': '2017-09-08', 'studyFirstSubmitQcDate': '2017-10-02', 'lastUpdatePostDateStruct': {'date': '2018-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Hospital readmission', 'timeFrame': '6 months', 'description': 'Measured as number of hospital readmissions'}], 'primaryOutcomes': [{'measure': 'Time to reach program goals (days)', 'timeFrame': 'Through study completion, an average of 4 weeks', 'description': 'The number of days in the COLTT program required to reach program goals ( see secondary outcomes measures)'}], 'secondaryOutcomes': [{'measure': 'Gait speed (mph, % expected)', 'timeFrame': 'Through study completion, an average of 4 weeks', 'description': 'Gait speed (walking speed) is measured daily on a oval track'}, {'measure': 'Single leg stance performance (seconds, % expected)', 'timeFrame': 'Through study completion, an average of 4 weeks', 'description': 'The test result of a single leg stance test. Patients stand with hands on their hips, raise one leg off the ground and hold it for as long as possible.'}, {'measure': 'One-minute sit to stand performance (number, % expected)', 'timeFrame': 'Through study completion, an average of 4 weeks', 'description': 'The test result of a one-minute sit to stand test. Patients stand/sit from a chair as many times as they can in one minute.'}, {'measure': 'Six minute walk distance (feet, % expected)', 'timeFrame': 'Through study completion, an average of 4 weeks', 'description': 'The test result of a six-minute walk test, a field test of exercise capacity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Transplant']}, 'referencesModule': {'references': [{'pmid': '27683630', 'type': 'BACKGROUND', 'citation': 'Wickerson L, Rozenberg D, Janaudis-Ferreira T, Deliva R, Lo V, Beauchamp G, Helm D, Gottesman C, Mendes P, Vieira L, Herridge M, Singer LG, Mathur S. Physical rehabilitation for lung transplant candidates and recipients: An evidence-informed clinical approach. World J Transplant. 2016 Sep 24;6(3):517-31. doi: 10.5500/wjt.v6.i3.517.'}, {'pmid': '22390625', 'type': 'BACKGROUND', 'citation': 'Langer D, Burtin C, Schepers L, Ivanova A, Verleden G, Decramer M, Troosters T, Gosselink R. Exercise training after lung transplantation improves participation in daily activity: a randomized controlled trial. Am J Transplant. 2012 Jun;12(6):1584-92. doi: 10.1111/j.1600-6143.2012.04000.x. Epub 2012 Mar 5.'}, {'pmid': '23815281', 'type': 'BACKGROUND', 'citation': 'Walsh JR, Chambers DC, Davis RJ, Morris NR, Seale HE, Yerkovich ST, Hopkins PM. Impaired exercise capacity after lung transplantation is related to delayed recovery of muscle strength. Clin Transplant. 2013 Jul-Aug;27(4):E504-11. doi: 10.1111/ctr.12163. Epub 2013 Jul 2.'}, {'pmid': '23974352', 'type': 'BACKGROUND', 'citation': 'Strassmann A, Steurer-Stey C, Lana KD, Zoller M, Turk AJ, Suter P, Puhan MA. Population-based reference values for the 1-min sit-to-stand test. Int J Public Health. 2013 Dec;58(6):949-53. doi: 10.1007/s00038-013-0504-z. Epub 2013 Aug 24.'}, {'pmid': '19839175', 'type': 'BACKGROUND', 'citation': 'Springer BA, Marin R, Cyhan T, Roberts H, Gill NW. Normative values for the unipedal stance test with eyes open and closed. J Geriatr Phys Ther. 2007;30(1):8-15. doi: 10.1519/00139143-200704000-00003.'}, {'pmid': '24812254', 'type': 'BACKGROUND', 'citation': 'Middleton A, Fritz SL, Lusardi M. Walking speed: the functional vital sign. J Aging Phys Act. 2015 Apr;23(2):314-22. doi: 10.1123/japa.2013-0236. Epub 2014 May 2.'}, {'pmid': '23294442', 'type': 'BACKGROUND', 'citation': 'Dierich M, Tecklenburg A, Fuehner T, Tegtbur U, Welte T, Haverich A, Warnecke G, Gottlieb J. The influence of clinical course after lung transplantation on rehabilitation success. Transpl Int. 2013 Mar;26(3):322-30. doi: 10.1111/tri.12048. Epub 2013 Jan 7.'}]}, 'descriptionModule': {'briefSummary': 'This is a retrospective review of the COLTT program outcomes and factors that predict recovery of functional status after lung transplantation.', 'detailedDescription': 'The Center of Life for Thoracic Transplant (COLTT) program is a daily (5 days per week) intensive rehabilitation program for patients who have undergone lung transplant. Patients are enrolled in COLTT as part of standard care after hospital discharge. This study is a retrospective review of seventy patients that measures the efficacy of the COLTT program and establishes predictors of patient success.This study will also measure the effect of functional outcomes on hospital readmission post COLTT discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Lung transplant recipients at IU Health Methodist Hospital. As part of standard care, all patients who survive to hospital discharge are referred by transplant pulmonologists to the COLTT program.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients who completed the COLTT program from May, 2016 to July, 2017.\n\nExclusion Criteria:\n\n* Any COLTT patients who were not new lung transplant recipients.'}, 'identificationModule': {'nctId': 'NCT03299504', 'briefTitle': 'Factors Predicting Success in Lung Transplant Recipients Who Have Undergone Intensive Post-operative Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University Health Methodist Hospital'}, 'officialTitle': 'Factors Predicting Success in Lung Transplant Recipients Who Have Participated in the COLTT Program (Daily Intensive Post-hospitalization Rehabilitation): A Retrospective Review', 'orgStudyIdInfo': {'id': 'RCS1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Exercise', 'type': 'OTHER', 'description': '5 days per week, 2.5 hours per day strength, balance and endurance training on an outpatient basis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'IU Health Methodist Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University Health Methodist Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dedicated Physical Therapist', 'investigatorFullName': 'Christen DiPerna', 'investigatorAffiliation': 'Indiana University Health Methodist Hospital'}}}}