Inspiratory Muscle Training in Lung Transplant Candidates and Implications on Early Post-Transplant Outcomes: A Pilot and Feasibility Multicenter Randomized Clinical Trial
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Canada
Centre hospitalier de l'Université de Montréal (CHUM)
RECRUITING
Montreal
University Health Network
RECRUITING
Toronto
Vancouver General Hospital
RECRUITING
Vancouver
Contact Information
Primary
Dmitry Rozenberg, MD, PhD
Dmitry.Rozenberg@uhn.ca
416-340-4800
Time Frame
Start Date:2024-08-06
Estimated Completion Date:2027-09-30
Participants
Target number of participants:90
Treatments
Experimental: IMT and exercise training group
Participants in the IMT and exercise training group will perform twice daily 30-breath IMT sessions and exercise training sessions three times per week as part of their usual care during the pre-lung transplant phase. The exercise training is comprised of aerobic, resistance and flexibility training.
No_intervention: Usual care group
Participants in the usual care group will take part in the standard of care rehabilitation program provided during the waitlist phase prior to the transplant. Exercise training is performed at least three times per week for the duration of the waitlist period. The exercise training includes a combination of supervised in-person visits and home-based training that incorporates aerobic, resistance and flexibility training.
Collaborators: Canadian Institutes of Health Research (CIHR), Canadian National Transplant Research Program, Ozmosis Research Inc., Centre hospitalier de l'Université de Montréal (CHUM), Vancouver General Hospital