Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06370832

Inspiratory Muscle Training in Lung Transplant Candidates

Led by University Health Network, Toronto · Updated on 2026-03-30

90

Participants Needed

4

Research Sites

164 weeks

Total Duration

On this page

Sponsors

U

University Health Network, Toronto

Lead Sponsor

C

Canadian National Transplant Research Program

Collaborating Sponsor

AI-Summary

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).

CONDITIONS

Official Title

Inspiratory Muscle Training in Lung Transplant Candidates

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult participants (18 years or older)
  • Candidates for lung transplantation
  • Participating in outpatient pulmonary rehabilitation as part of standard care
  • Diagnosed with Interstitial Lung Disease or Chronic Obstructive Pulmonary Disease
Not Eligible

You will not qualify if you...

  • Respiratory exacerbation within the last 1 month
  • Neurologic or musculoskeletal conditions interfering with training or assessments (e.g., stroke, severe hand arthritis)
  • Insufficient English fluency to provide consent or follow study procedures
  • Evidence of pneumothorax on imaging within the last 6 months
  • Current ruptured eardrums or ear infections causing fluid behind ear drum
  • Significant heart issues shown by catheterization or echocardiogram
  • Severe osteoporosis with a history of rib fractures
  • Presence of cardiac pacemaker or other electronic/magnetic implants
  • Rapidly deteriorating condition or inpatient status at assessment
  • Awaiting lung re-transplant
  • Inability to connect to the internet

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 4 locations

1

Edmonton Lung Transplant Program

Edmonton, Alberta, Canada, T6G 2G3

Actively Recruiting

2

Vancouver General Hospital

Vancouver, British Columbia, Canada

Actively Recruiting

3

University Health Network

Toronto, Ontario, Canada, M5G 2C4

Actively Recruiting

4

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

Actively Recruiting

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Research Team

D

Dmitry Rozenberg, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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