Inspiratory Muscle Training in Lung Transplant Candidates
Recruiting · NCT06370832 · Interventional (participants receive a specific treatment) · Lead sponsor: University Health Network, Toronto
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 multicenter randomized clinical trial of IMT in LTx candidates in terms of recruitment rate, retention, program adherence, and outcome ascertainment; (2) To establish the change in pre-transplant dyspnea perception, diaphragm structure and function, health related quality of life (HRQoL) and post-transplant intensive care unit (ICU), hospital and post-transplant 3-month outcomes with IMT relative to usual care group; and (3) To characterize the effect of pre-transplant IMT on peri-transplant diaphragm myofibrillar cross-sectional area (CSA), oxidative capacity, inflammatory markers and post-transplant diaphragm muscle thickness and function (UHN TGH site).
Who can take part
Inclusion criteria
- Adult participants (≥ 18 years of age)
- Lung Transplant Candidates
- Participating in outpatient pulmonary rehabilitation (standard of care)
- Diagnosis of Interstitial Lung Disease or Chronic Obstructive Pulmonary Disease
Exclusion criteria
- Respiratory exacerbation within the last 1 month
- Neurologic or musculoskeletal conditions that may interfere with IMT or functional assessments (i.e. history of stroke, severe arthritis of hands)
- Insufficient English fluency to provide informed consent or to follow study protocols
- Any evidence of pneumothorax on recent imaging (\< 6 months)
- Present ruptures of eardrums or infections leading to fluid behind ear drum
- Marked left or right ventricular end-diastolic volume and pressure overload on right heart catheterization or echocardiogram
- Severe osteoporosis with history of rib fractures
- Cardiac pacemaker or other electronic or magnetic body implant
- Individuals listed as rapidly deteriorating or inpatient at the time of eligibility assessment
- Individuals awaiting a re-transplant
- Inability of the patient to connect to the internet
Where it is running
4 locations listed.
- Edmonton Lung Transplant Program - Edmonton, Alberta, Canada
- Vancouver General Hospital - Vancouver, British Columbia, Canada
- University Health Network - Toronto, Ontario, Canada
- Centre hospitalier de l'Université de Montréal (CHUM) - Montreal, Quebec, Canada