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Inspiratory Muscle Training in Lung Transplant Candidates

Inspiratory Muscle Training

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 randomized clinical trial of IMT in LTx candidates in terms of recruitment rate, retention, program adherence, safety and outcome ascertainment. 2)To establish whether IMT improves pre-transplant dyspnea perception, diaphragm structure and function, HRQoL and post-transplant ICU, hospital and 3-month outcomes. 3)To characterize the effect of pre-transplant IMT on peri-transplant diaphragm myofibrillar cross-sectional area, oxidative capacity, inflammatory markers and diaphragm muscle thickness and function. Methods: Prospective study of 50 LTx candidates recruited from the pulmonary rehabilitation program at University Health Network (UHN). Participants will have baseline evaluations of maximal inspiratory pressure (MIP), dyspnea, respiratory muscle endurance, diaphragm thickness and thickening fractions, as well as health-related quality of life questionnaires. After baseline assessments, participants will be randomized to the two study groups: IMT or usual care. IMT will be progressed weekly (max of 70% total MIP) until transplant. Participants will have repeat assessments (from baseline) at 4,8 and 12 weeks and then every 3 months until transplant (final assessment 3 months post-LTx).

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    18 and up

Participation 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

Study Location

University Health Network
University Health Network
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Dmitry Rozenberg, MD, PhD

[email protected]
416-340-4800
Study Sponsored By
University Health Network, Toronto
Participants Required
More Information
Study ID: NCT06370832