Recruiting

Inspiratory Muscle Training

Sponsor:

University Health Network, Toronto

Code:

NCT06370832

Conditions

Inspiratory Muscle Training

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

IMT and exercise training group

Study Details

Brief 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).

Conditions

Inspiratory Muscle Training

Study ID

NCT06370832

Start date

Aug 6, 2024

Status verified date

Sep, 2025

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

IMT 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.

Primary outcome measure

  • Study Recruitment According to Research Team Records [ Time Frame: Over study recruitment period (approximately 2 years) ]
  • Participant Retention in the Study According to Research Team Records [ Time Frame: Over the study data collection period (from enrolment until 3 months post-transplant) ]
  • Self-Reported Adherence to Inspiratory Muscle Training According to Participant IMT Diary [ Time Frame: Over intervention period (from randomization until time of transplantation, up to maximum of 24 months) ]
  • Adverse Events and IMT Training Side Effects Reported by Participants [ Time Frame: Over intervention period (from randomization until time of transplantation, up to maximum of 24 months) ]
  • Inspiratory Muscle Training Satisfaction Questionnaire (IMT Group Only) [ Time Frame: At 3 months post-transplant follow-up ]

Central Contacts and Locations

Central contacts

Dmitry Rozenberg, MD, PhD

416-340-4800Dmitry.Rozenberg@uhn.ca

Locations

Edmonton Lung Transplant Program

Recruiting

Edmonton, Alberta, Canada, T6G 2G3

Contacts

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada

Contacts

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Dmitry Rozenberg, MD, PhD

416-340-4800dmitry.rozenberg@uhn.ca

Centre hospitalier de l'Université de Montréal (CHUM)

Recruiting

Montreal, Quebec, Canada

Contacts

More Information

Sponsor

University Health Network, Toronto

Last update posted

Mar 30, 2026

Last verified

Sep, 2025

Keywords

  • Lung transplant candidates
  • Exercise training
  • Prehabilitation
  • Chronic Obstructive Pulmonary Disease
  • Interstitial Lung Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-03-30.