NCT06370832Recruiting
Inspiratory Muscle Training in Lung Transplant Candidates
Inspiratory Muscle Training in Lung Transplant Candidates and Implications on Early Post-Transplant Outcomes: A Pilot and Feasibility Multicenter Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 30 Mar 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 4 Mar 2024
- Start date
- 6 Aug 2024
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- University Health Network, Toronto
- Diseases
- COPD
- NCT number
- NCT06370832
What you commit to
- Study type: Interventional
- Planned participants: 90
- From 6 Aug 2024 to the primary completion date, 30 Sept 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Individuals awaiting a re-transplant
Other illness
- Neurologic or musculoskeletal conditions that may interfere with IMT or functional assessments (i.e. history of stroke, severe arthritis of hands)
- 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
Other
- Respiratory exacerbation within the last 1 month
- Insufficient English fluency to provide informed consent or to follow study protocols
- Any evidence of pneumothorax on recent imaging (\< 6 months)
- Individuals listed as rapidly deteriorating or inpatient at the time of eligibility assessment
- Inability of the patient to connect to the internet
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Edmonton Lung Transplant Program Coordinator of this site? Confirm its status | Edmonton | Canada | Recruiting |
| Centre Hospitalier de l'Universite de Montreal (CHUM) Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| University Health Network Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Vancouver General Hospital Coordinator of this site? Confirm its status | Vancouver | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.