Improving lung transplant outcomes with inspiratory muscle training
Inspiratory Muscle Training in Lung Transplant Candidates and Implications on Early Post-Transplant Outcomes: A Pilot and Feasibility Multicenter Randomized Clinical Trial
This study tests if a special breathing exercise program can help people waiting for a lung transplant breathe better and recover more smoothly after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 4 sites (Edmonton, Alberta and 3 other locations) |
| Trial ID | NCT06370832 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the feasibility and effectiveness of inspiratory muscle training (IMT) for lung transplant candidates. The study aims to assess how IMT can enhance respiratory muscle strength and potentially reduce post-operative complications after lung transplantation. Participants will engage in a structured exercise training program while undergoing outpatient pulmonary rehabilitation. The trial will evaluate recruitment rates, retention, adherence to the program, and changes in dyspnea perception and diaphragm function.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are lung transplant candidates with a diagnosis of interstitial lung disease or chronic obstructive pulmonary disease.
Not a fit: Patients with recent respiratory exacerbations, significant neurological or musculoskeletal conditions, or those currently hospitalized may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved recovery and reduced complications for lung transplant patients.
How similar studies have performed: Previous studies have shown that inspiratory muscle training can reduce post-operative complications in other surgical populations, suggesting potential for success in this context.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Edmonton, Alberta and 3 other locations
- Edmonton Lung Transplant Program — Edmonton, Alberta, Canada (Recruiting)
- Vancouver General Hospital — Vancouver, British Columbia, Canada (Recruiting)
- University Health Network — Toronto, Ontario, Canada (Recruiting)
- Centre hospitalier de l'Université de Montréal (CHUM) — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Dmitry Rozenberg, MD, PhD — University Health Network/University of Toronto
- Study coordinator: Dmitry Rozenberg, MD, PhD
- Email: Dmitry.Rozenberg@uhn.ca
- Phone: 416-340-4800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.