nctId: NCT06370832 id: 22-5171 briefTitle: Inspiratory Muscle Training in Lung Transplant Candidates overallStatus: NOT_YET_RECRUITING date: 2024-05-01 date: 2026-09-30 date: 2027-09-30 date: 2024-04-17 date: 2024-04-17 name: University Health Network, Toronto class: OTHER name: Canadian National Transplant Research Program name: Canadian Institutes of Health Research (CIHR) name: Ozmosis Research Inc. 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). conditions: Inspiratory Muscle Training studyType: INTERVENTIONAL phases: NA 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 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 count: 50 type: ESTIMATED name: IMT and exercise training group measure: Study Recruitment According to Research Team Records measure: Participant Retention in the Study According to Research Team Records measure: Self-Reported Adherence to Inspiratory Muscle Training According to Participant IMT Diary measure: Adverse Events and IMT Training Side Effects Reported by Participants measure: Inspiratory Muscle Training Satisfaction Questionnaire (IMT Group Only) measure: Respiratory Muscle Endurance Test measure: Dyspnea Severity Assessed by Medical Research Council Dyspnea Scale measure: Qualitative Measures of Dyspnea Assessed by Qualitative Dyspnea Scale measure: Mood Assessed by Depression, Anxiety, and Stress Scale measure: Health-Related Quality of Life Assessed by St. George's Respiratory Questionnaire measure: Respiratory Muscle Strength Assessed by Maximal Inspiratory Pressure measure: Physical Activity and Exercise Behaviors Assessed by International Physical Activity Questionnaire measure: Pulmonary Function Testing (Spirometry) measure: Aerobic Endurance Assessed by the Six-Minute Walk Test measure: Physical Function Assessed by the Short Physical Performance Battery measure: Pre-Transplant Hospitalizations measure: Peri-Transplant Mechanical Ventilation Bridging measure: Post-Transplant Duration of Mechanical Ventilation (Days) measure: WIND Weaning Classification measure: Post-Transplant Hospital Length of Stay (Days) measure: Post-Transplant Discharge Disposition measure: Primary Graft Dysfunction measure: Post-Transplant Mortality measure: Days Alive and at Home at 90 Days (DAAH90) measure: Diaphragm Thickness and Thickening Fraction Assessed by Ultrasound measure: Histopathology Analyses of Diaphragm Biopsies (Optional) measure: Biochemical Analyses of Diaphragm Biopsies (Optional) measure: Mitochondrial Respirometry Analyses of Diaphragm Biopsies (Optional) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University Health Network city: Toronto state: Ontario zip: M5G 2C4 country: Canada name: Dmitry Rozenberg, MD, PhD role: CONTACT phone: 416-340-4800 phoneExt: 7358 email: dmitry.rozenberg@uhn.ca lat: 43.70011 lon: -79.4163 hasResults: False