protocolSection identificationModule nctId: NCT06370832, orgStudyIdInfo id: 22-5171, briefTitle: Inspiratory Muscle Training in Lung Transplant Candidates, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-09-30, completionDateStruct date: 2027-09-30, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: University Health Network, Toronto, class: OTHER, collaborators name: Canadian National Transplant Research Program, collaborators name: Canadian Institutes of Health Research (CIHR), collaborators name: Ozmosis Research Inc., descriptionModule briefSummary: Recovery after lung transplantation (LTx) may be complicated by prolonged mechanical ventilation (MV) and protracted intensive care unit (ICU) stay leading to immobilization and impaired health-related quality of life (HRQoL). In the critical care setting, diaphragm atrophy and weakness have been associated with difficulty weaning from MV, increased risk for readmission to hospital or ICU, and increased mortality. Increasing respiratory muscle strength by inspiratory muscle training (IMT) as part of pre-rehabilitation mitigates respiratory muscle dysfunction peri-operatively and may reduce the risk of post-operative complications. However, IMT is not widely used prior to LTx and the benefits of pre-operative IMT on post-transplant outcomes in LTx candidates have not been studied. Objectives: 1) To evaluate the feasibility of a randomized clinical trial of IMT in LTx candidates in terms of recruitment rate, retention, program adherence, safety and outcome ascertainment. 2)To establish whether IMT improves pre-transplant dyspnea perception, diaphragm structure and function, HRQoL and post-transplant ICU, hospital and 3-month outcomes. 3)To characterize the effect of pre-transplant IMT on peri-transplant diaphragm myofibrillar cross-sectional area, oxidative capacity, inflammatory markers and diaphragm muscle thickness and function. Methods: Prospective study of 50 LTx candidates recruited from the pulmonary rehabilitation program at University Health Network (UHN). Participants will have baseline evaluations of maximal inspiratory pressure (MIP), dyspnea, respiratory muscle endurance, diaphragm thickness and thickening fractions, as well as health-related quality of life questionnaires. After baseline assessments, participants will be randomized to the two study groups: IMT or usual care. IMT will be progressed weekly (max of 70% total MIP) until transplant. Participants will have repeat assessments (from baseline) at 4,8 and 12 weeks and then every 3 months until transplant (final assessment 3 months post-LTx)., conditionsModule conditions: Inspiratory Muscle Training, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Pre-lung transplant candidates will be randomized to one of two groups: (1) IMT + exercise training; or (2) exercise training alone., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Ascertainment of post-transplant clinical outcomes (including histopathology assessments) will be blinded by assessors to study group up to 3 months post-transplant., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: IMT and exercise training group, outcomesModule primaryOutcomes measure: Study Recruitment According to Research Team Records, primaryOutcomes measure: Participant Retention in the Study According to Research Team Records, primaryOutcomes measure: Self-Reported Adherence to Inspiratory Muscle Training According to Participant IMT Diary, primaryOutcomes measure: Adverse Events and IMT Training Side Effects Reported by Participants, primaryOutcomes measure: Inspiratory Muscle Training Satisfaction Questionnaire (IMT Group Only), secondaryOutcomes measure: Respiratory Muscle Endurance Test, secondaryOutcomes measure: Dyspnea Severity Assessed by Medical Research Council Dyspnea Scale, secondaryOutcomes measure: Qualitative Measures of Dyspnea Assessed by Qualitative Dyspnea Scale, secondaryOutcomes measure: Mood Assessed by Depression, Anxiety, and Stress Scale, secondaryOutcomes measure: Health-Related Quality of Life Assessed by St. George's Respiratory Questionnaire, secondaryOutcomes measure: Respiratory Muscle Strength Assessed by Maximal Inspiratory Pressure, secondaryOutcomes measure: Physical Activity and Exercise Behaviors Assessed by International Physical Activity Questionnaire, secondaryOutcomes measure: Pulmonary Function Testing (Spirometry), secondaryOutcomes measure: Aerobic Endurance Assessed by the Six-Minute Walk Test, secondaryOutcomes measure: Physical Function Assessed by the Short Physical Performance Battery, secondaryOutcomes measure: Pre-Transplant Hospitalizations, secondaryOutcomes measure: Peri-Transplant Mechanical Ventilation Bridging, secondaryOutcomes measure: Post-Transplant Duration of Mechanical Ventilation (Days), secondaryOutcomes measure: WIND Weaning Classification, secondaryOutcomes measure: Post-Transplant Hospital Length of Stay (Days), secondaryOutcomes measure: Post-Transplant Discharge Disposition, secondaryOutcomes measure: Primary Graft Dysfunction, secondaryOutcomes measure: Post-Transplant Mortality, secondaryOutcomes measure: Days Alive and at Home at 90 Days (DAAH90), otherOutcomes measure: Diaphragm Thickness and Thickening Fraction Assessed by Ultrasound, otherOutcomes measure: Histopathology Analyses of Diaphragm Biopsies (Optional), otherOutcomes measure: Biochemical Analyses of Diaphragm Biopsies (Optional), otherOutcomes measure: Mitochondrial Respirometry Analyses of Diaphragm Biopsies (Optional), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University Health Network, city: Toronto, state: Ontario, zip: M5G 2C4, country: Canada, contacts name: Dmitry Rozenberg, MD, PhD, role: CONTACT, phone: 416-340-4800, phoneExt: 7358, email: dmitry.rozenberg@uhn.ca, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False