NCT06370832 Inspiratory Muscle Training in Lung Transplant Candidates
| NCT ID | NCT06370832 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Health Network, Toronto |
| Condition | Inspiratory Muscle Training |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-08-06 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2024-08-06 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
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
Contact & Investigator
Dmitry Rozenberg, MD, PhD
PRINCIPAL INVESTIGATOR
University Health Network/University of Toronto
Frequently Asked Questions
Who can join the NCT06370832 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Inspiratory Muscle Training. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06370832 currently recruiting?
Yes, NCT06370832 is actively recruiting participants. Contact the research team at Dmitry.Rozenberg@uhn.ca for enrollment information.
Where is the NCT06370832 trial being conducted?
This trial is being conducted at Edmonton, Canada, Vancouver, Canada, Toronto, Canada, Montreal, Canada.
Who is sponsoring the NCT06370832 clinical trial?
NCT06370832 is sponsored by University Health Network, Toronto. The principal investigator is Dmitry Rozenberg, MD, PhD at University Health Network/University of Toronto. The trial plans to enroll 90 participants.