RecruitingNot ApplicableNCT06370832

Inspiratory Muscle Training in Lung Transplant Candidates

Inspiratory Muscle Training in Lung Transplant Candidates and Implications on Early Post-Transplant Outcomes: A Pilot and Feasibility Multicenter Randomized Clinical Trial


Sponsor

University Health Network, Toronto

Enrollment

90 participants

Start Date

Aug 6, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding specific breathing muscle exercises (inspiratory muscle training) to standard lung rehabilitation can improve strength and fitness in people waiting for a lung transplant. **You may be eligible if...** - You are 18 or older and on a lung transplant waiting list - You have been diagnosed with Interstitial Lung Disease (ILD) or Chronic Obstructive Pulmonary Disease (COPD) - You are already enrolled in outpatient pulmonary rehabilitation **You may NOT be eligible if...** - You had a respiratory flare-up in the past month - You have a neurological or joint condition that would prevent you from doing the exercises - You have had a recent pneumothorax (collapsed lung) in the last 6 months - You have eardrum rupture or ear infection - You have severe heart pressure problems detected on cardiac testing - You are not sufficiently fluent in English to follow the study protocol Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERIMT and exercise training group

Participants will perform supervised exercise training per usual care and will be provided with a personalized prescription for an IMT program during the pre-transplant phase. Participants will perform two daily IMT sessions of 30 breaths (\< 5 minutes/session) 5 days per week in their home environment or in-person visits. IMT intensity will be progressed weekly by 5-10% of the baseline maximal inspiratory pressure if the Borg Dyspnea score is \< 7.


Locations(4)

Edmonton Lung Transplant Program

Edmonton, Alberta, Canada

Vancouver General Hospital

Vancouver, British Columbia, Canada

University Health Network

Toronto, Ontario, Canada

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

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NCT06370832


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