Inspiratory Muscle TrainingNCT06370832
Inspiratory Muscle Training in Lung Transplant Candidates
A study testing IMT and exercise training group in people with Inspiratory Muscle Training, run by University Health Network, Toronto at 4 sites in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inspiratory Muscle Training
- What is being tested?
- IMT and exercise training group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 4 sitesCanada
- Study dates
- 6 Aug 2024to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada4 sites, 4 recruiting
- Recruiting
Edmonton Lung Transplant Program
Edmonton, Alberta, T6G 2G3
Kieran Halloran, MD, (780) 492-2691, kieran@ualberta.ca
- Recruiting
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec
Tania Janaudis-Ferreira, PhD, 514-619-0871, tania.janaudis-ferreira@mcgill.ca
- Recruiting
University Health Network
Toronto, Ontario, M5G 2C4
Dmitry Rozenberg, MD, PhD, 416-340-4800 ext. 7358, dmitry.rozenberg@uhn.ca
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia
Jordan Guenette, PhD, 604-806-8835, Jordan.Guenette@hli.ubc.ca
About this study
Official title: Inspiratory Muscle Training in Lung Transplant Candidates and Implications on Early Post-Transplant Outcomes: A Pilot and Feasibility Multicenter Randomized Clinical Trial
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).
Read the detailed description
Diaphragm atrophy at the time of initiating mechanical ventilation (MV) after solid organ transplantation and major surgery is associated with prolonged MV and higher hospital mortality. The incidence of diaphragm dysfunction after LTx is estimated to be up to 30%; post-transplant diaphragm dysfunction is associated with prolonged MV and hospitalization after LTx.
The American Thoracic Society/European Respiratory Society (2013) guidelines recommend further evaluation of inspiratory muscle training (IMT) combined with routine rehabilitation prior to major surgery. Pre-operative IMT in patients with even normal maximal inspiratory pressures (MIP) have been shown to decrease post-operative pulmonary complications and shorten hospitalization after cardio-thoracic surgery. However, pre-operative IMT is not commonly used for LTx candidates and its benefits are poorly researched. IMT may prove to be a simple pre-transplant intervention to prevent post-transplant morbidity and improve post-transplant functional status. The current focus is to investigate the impact of IMT on early post-lung transplant results while evaluating its effectiveness through a pilot multicenter randomized controlled trial.
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.
- 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.
- 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).
Hypotheses: 1) It will be feasible to recruit LTx candidates into an IMT program RCT with a consent rate ≥ 30 %, enrolment rate of 2-3 patients per month at UHN and 1 patient per month at each other participating site, adequate outcome ascertainment (≥ 80%), and acceptable adherence (≥ 80% compliance with IMT sessions). 2) IMT will increase respiratory muscle endurance by 20% and improve exertional dyspnea and HRQoL in comparison to usual care over the pre-transplant period. IMT will be associated with greater hospital free days at 90 days. 3) pre-transplant IMT increases diaphragm myofibrillar CSA and post-LTx diaphragm thickness and maximal diaphragm thickening during inspiration in comparison to usual care. The improved mitochondrial respiration will occur concurrently with improvements in muscle fiber size, immune infiltration and oxidative stress.
The IMT and exercise training group (IMT group) will perform two daily IMT sessions of 30 breaths (< 5 minutes/session) during the pre-LTx period. IMT will start at 30% of MIP with a 5-10% weekly increase in training intensity guided by weekly MIP as tolerated (median weekly Borg dyspnea score < 7 during IMT until reaching 70% of MIP) and continued until LTx. In conjunction with their IMT program, IMT group participants will undergo exercise training at least three times per week as part of their usual care. The control group (exercise training group) will perform exercise training as part of their usual care three times per week for the duration of the waitlist period. The exercise regimen for both groups consists of aerobic, resistance, and flexibility training supervised by a physiotherapist approximately three times a week. The training includes a combination of in-person visits and home-based sessions. Both groups will also receive a respiratory endurance device to evaluate respiratory endurance throughout the trial.
IMT can improve respiratory muscle strength and endurance, potentially helping those who are candidates for LTx. In addition, studying patients undergoing LTx affords unique opportunities to investigate the mechanistic effects of IMT on diaphragm structure and function.
- Conditions
- Inspiratory Muscle Training
- Being tested
- IMT and exercise training group
- Keywords
- Lung transplant candidates, Exercise training, Prehabilitation, Chronic Obstructive Pulmonary Disease, Interstitial Lung Disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMT and exercise training groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| IMT and exercise training group | Experimental | 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. Receives: Other: IMT and exercise training group |
| Usual care group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Recruitment According to Research Team Records
Recruitment-success percentage in the study will be assessed based on research team study records.
Measured: Over study recruitment period (approximately 2 years)
Participant Retention in the Study According to Research Team Records
Participant retention will be assessed by measuring participant follow-up throughout the study period, according to research team records. A retention rate of 80% or greater (in each group) has been established as the criteria to determine study feasibility.
Measured: 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
Adherence to inspiratory muscle training will be assessed via the IMT training diary completed by participants. Successful adherence will be defined as completion of ≥ 80% training sessions.
Measured: 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
Adverse events and training side-effects (e.g., muscle soreness) with inspiratory muscle training will be monitored through participant training diaries during the study intervention period. The research coordinator will review these diaries with participants on a weekly basis. Additionally, participants will be strongly encouraged to promptly inform the study team if they experience any challenges with IMT.
Measured: Over intervention period (from randomization until time of transplantation, up to maximum of 24 months)
Inspiratory Muscle Training Satisfaction Questionnaire (IMT Group Only)
Participant satisfaction and motivation with the IMT intervention will be determined using a satisfaction questionnaire.
Measured: At 3 months post-transplant follow-up
Secondary outcomes (19)
Respiratory Muscle Endurance Test
Respiratory muscle endurance (measured in seconds) will be assessed at 30-50% of Maximum Inspiratory Pressure (MIP) using a manual threshold loading device (Powerbreathe Classic light resistance trainer)
Measured: Change from baseline at 4 weeks, 8 weeks, 12 weeks, every 3 months until lung transplant (up to 24 months total), and 3 months post-transplant
Dyspnea Severity Assessed by Medical Research Council Dyspnea Scale
The Medical Research Council Dyspnea Scale will be used to assess the effect of breathlessness on daily activities. The scale comprises five statements that describe the range of respiratory dyspnea from none (Grade 1) to severe with difficulties performing self-care (Grade 5).
Measured: Change from baseline at 4 weeks, 8 weeks, 12 weeks, every 3 months until lung transplant (up to 24 months total), and 3 months post-transplant
Qualitative Measures of Dyspnea Assessed by Qualitative Dyspnea Scale
The 18-point Qualitative Dyspnea Scale will be ascertained at each follow-up time point. Participants will be presented with a list of 18 qualitative descriptors of dyspnea experience and will be asked to rank their top three.
Measured: Change from baseline at 4 weeks, 8 weeks, 12 weeks, every 3 months until lung transplant (up to 24 months total), and 3 months post-transplant
Mood Assessed by Depression, Anxiety, and Stress Scale
The Depression, Anxiety and Stress Scale (DASS-21) questionnaire has 21 items to assess mood (anxiety, depression, and stress). Each statement for the three domains is given a score of 0 (not applicable) to 3 (applicable most of the time) with scores categorized as follows: Normal, Mild, Moderate, Severe, and Extremely Severe.
Measured: Change from baseline at 4 weeks, 8 weeks, 12 weeks, every 3 months until lung transplant (up to 24 months total), and 3 months post-transplant
Health-Related Quality of Life Assessed by St. George's Respiratory Questionnaire
Health-related Quality of Life (HRQL) will be assessed through the St. George's Respiratory Questionnaire (SGRQ) and consists of three domains (symptoms, activity and impacts) and total score. The SGRQ has a range of scores from 0 to 100 with higher scores signifying worse HRQL.
Measured: Change from baseline at 4 weeks, 8 weeks, 12 weeks, every 3 months until lung transplant (up to 24 months total), and 3 months post-transplant
Respiratory Muscle Strength Assessed by Maximal Inspiratory Pressure
Respiratory muscle strength will be quantified as Maximal Inspiratory Pressure (MIP), evaluated using a respiratory muscle trainer (PowerBreathe KH2).
Measured: Change from baseline at 4 weeks, 8 weeks, 12 weeks, every 3 months until lung transplant (up to 24 months total), time of liberation from mechanical ventilation, and 3 months post-transplant
Physical Activity and Exercise Behaviors Assessed by International Physical Activity Questionnaire
The International Physical Activity Questionnaire - Short Form (IPAQ-SF) will be used to measure physical activity levels in study participants. The questionnaire consists of seven questions to capture average daily time spent sitting, walking, and engaging in moderate and vigorous physical activity over the last seven days. The IPAQ-SF provides an overall physical activity level of participants based on their Metabolic Equivalent Task minutes per week.
Measured: Change from baseline at 4 weeks, 8 weeks, 12 weeks, every 3 months until lung transplant (up to 24 months total), and 3 months post-transplant
Pulmonary Function Testing (Spirometry)
Clinical charts will be reviewed to obtain results from spirometry assessments including Forced Vital Capacity (FVC), and Forced Expiratory Volume in the first second (FEV1).
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, every 3 months until lung transplant (up to 24 months total), and 3 months post-transplant
Aerobic Endurance Assessed by the Six-Minute Walk Test
Clinical rehabilitation charts will be reviewed to document aerobic endurance as assessed by distance walked during the Six-Minute Walk Test.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, every 3 months until lung transplant (up to 24 months total), and 3 months post-transplant
Physical Function Assessed by the Short Physical Performance Battery
Clinical rehabilitation charts will be reviewed to document physical function as assessed by the Short-Physical Performance Battery, which evaluates balance, gait speed, and ability to rise from a chair 5 times.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, every 3 months until lung transplant (up to 24 months total), and 3 months post-transplant
Pre-Transplant Hospitalizations
Clinical charts will be reviewed to document any hospitalizations and ICU admissions before the time of transplantation.
Measured: From baseline up until the time of admission for the index transplant hospitalization (up to 24 months total)
Peri-Transplant Mechanical Ventilation Bridging
Clinical charts will be reviewed to determine whether mechanical ventilation or extracorporeal membrane oxygenation (ECMO) were required as a bridge to transplantation.
Measured: Peri-operative period, from time of index transplant hospital admission to time of transplant surgery (up to 24 months total)
Post-Transplant Duration of Mechanical Ventilation (Days)
Clinical charts will be reviewed to determine the duration of mechanical ventilation required following transplantation surgery, measured in days.
Measured: From time of transplant surgery to the time of liberation from mechanical ventilation (up to 3 months total)
WIND Weaning Classification
The WIND weaning classification (short, difficult, or prolonged) will be ascertained by ICU staff at the time of liberation from mechanical ventilation based on the number of spontaneous breathing trials and weaning difficulty.
Measured: At the time of liberation from mechanical ventilation following transplant surgery (up to 3 months total).
Post-Transplant Hospital Length of Stay (Days)
Clinical charts will be reviewed to determine the length of stay in hospital following transplant surgery, measured in days.
Measured: From time of transplant surgery to the time of discharge from hospital (up to 3 months total).
Post-Transplant Discharge Disposition
Clinical charts will be reviewed to determine participants' discharge disposition from the index transplant hospitalization (e.g., home, inpatient rehabilitation, long-term care).
Measured: Time of discharge from index transplant hospitalization (up to 3 months total).
Primary Graft Dysfunction
Clinical charts will be reviewed to determine the presence and severity of primary graft dysfunction following transplant surgery.
Measured: Up to 72 hours post-transplant
Post-Transplant Mortality
Clinical charts will be reviewed to document post-transplant mortality and etiology.
Measured: Up to 90 days (3 months) post-transplant
Days Alive and at Home at 90 Days (DAAH90)
Clinical charts will be reviewed to determine the number of days participants are alive and at home at 90 days post-transplant.
Measured: Up to 90 days (3 months) post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start6 Aug 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Inspiratory Muscle TrainingStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pre-lung transplant candidates will be randomized to one of two groups: (1) IMT + exercise training; or (2) exercise training alone.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian National Transplant Research Program, Canadian Institutes of Health Research (CIHR), Ozmosis Research Inc., Centre hospitalier de l'Université de Montréal (CHUM), Vancouver General Hospital
- Responsible party
- Sponsor
- Investigators
- Dmitry Rozenberg, MD, PhD, Principal investigator, University Health Network/University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06370832
- Sponsor's protocol ID
- 22-5171
- Status last verified
- Sep 2025
- First submitted
- 4 Mar 2024
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Weill D, Benden C, Corris PA, Dark JH, Davis RD, Keshavjee S, Lederer DJ, Mulligan MJ, Patterson GA, Singer LG, Snell GI, Verleden GM, Zamora MR, Glanville AR. A consensus document for the selection of lung transplant candidates: 2014--an update from the Pulmonary Transplantation Council of the International Society for Heart and Lung Transplantation. J Heart Lung Transplant. 2015 Jan;34(1):1-15. doi: 10.1016/j.healun.2014.06.014. Epub 2014 Jun 26.
PubMed 25085497Hook JL, Lederer DJ. Selecting lung transplant candidates: where do current guidelines fall short? Expert Rev Respir Med. 2012 Feb;6(1):51-61. doi: 10.1586/ers.11.83.
PubMed 22283579Fuehner T, Kuehn C, Welte T, Gottlieb J. ICU Care Before and After Lung Transplantation. Chest. 2016 Aug;150(2):442-50. doi: 10.1016/j.chest.2016.02.656. Epub 2016 Mar 4.
PubMed 26953218Christie JD, Kotloff RM, Ahya VN, Tino G, Pochettino A, Gaughan C, DeMissie E, Kimmel SE. The effect of primary graft dysfunction on survival after lung transplantation. Am J Respir Crit Care Med. 2005 Jun 1;171(11):1312-6. doi: 10.1164/rccm.200409-1243OC. Epub 2005 Mar 11.
PubMed 15764726Adler D, Dupuis-Lozeron E, Richard JC, Janssens JP, Brochard L. Does inspiratory muscle dysfunction predict readmission after intensive care unit discharge? Am J Respir Crit Care Med. 2014 Aug 1;190(3):347-50. doi: 10.1164/rccm.201404-0655LE. No abstract available.
PubMed 25084264Sklar MC, Dres M, Fan E, Rubenfeld GD, Scales DC, Herridge MS, Rittayamai N, Harhay MO, Reid WD, Tomlinson G, Rozenberg D, McClelland W, Riegler S, Slutsky AS, Brochard L, Ferguson ND, Goligher EC. Association of Low Baseline Diaphragm Muscle Mass With Prolonged Mechanical Ventilation and Mortality Among Critically Ill Adults. JAMA Netw Open. 2020 Feb 5;3(2):e1921520. doi: 10.1001/jamanetworkopen.2019.21520.
PubMed 32074293
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspiratory Muscle Training in Lung Transplant Candidates and Implications on Early Post-Transplant Outcomes: A Pilot and Feasibility Multicenter Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06370832
- Acronym / sponsor ID
- 22-5171
- Conditions
- Inspiratory Muscle Training
- Keywords
- Lung transplant candidates, Exercise training, Prehabilitation, Chronic Obstructive Pulmonary Disease, Interstitial Lung Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Canadian National Transplant Research Program, Canadian Institutes of Health Research (CIHR), Ozmosis Research Inc., Centre hospitalier de l'Université de Montréal (CHUM), Vancouver General Hospital
- Study start
- 6 Aug 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Diaphragm atrophy at the time of initiating mechanical ventilation (MV) after solid organ transplantation and major surgery is associated with prolonged MV and higher hospital mortality. The incidence of diaphragm dysfunction after LTx is estimated to be up to 30%; post-transplant diaphragm dysfunction is associated with prolonged MV and hospitalization after LTx.
The American Thoracic Society/European Respiratory Society (2013) guidelines recommend further evaluation of inspiratory muscle training (IMT) combined with routine rehabilitation prior to major surgery. Pre-operative IMT in patients with even normal maximal inspiratory pressures (MIP) have been shown to decrease post-operative pulmonary complications and shorten hospitalization after cardio-thoracic surgery. However, pre-operative IMT is not commonly used for LTx candidates and its benefits are poorly researched. IMT may prove to be a simple pre-transplant intervention to prevent post-transplant morbidity and improve post-transplant functional status. The current focus is to investigate the impact of IMT on early post-lung transplant results while evaluating its effectiveness through a pilot multicenter randomized controlled trial.
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.
- 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.
- 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).
Hypotheses: 1) It will be feasible to recruit LTx candidates into an IMT program RCT with a consent rate ≥ 30 %, enrolment rate of 2-3 patients per month at UHN and 1 patient per month at each other participating site, adequate outcome ascertainment (≥ 80%), and acceptable adherence (≥ 80% compliance with IMT sessions). 2) IMT will increase respiratory muscle endurance by 20% and improve exertional dyspnea and HRQoL in comparison to usual care over the pre-transplant period. IMT will be associated with greater hospital free days at 90 days. 3) pre-transplant IMT increases diaphragm myofibrillar CSA and post-LTx diaphragm thickness and maximal diaphragm thickening during inspiration in comparison to usual care. The improved mitochondrial respiration will occur concurrently with improvements in muscle fiber size, immune infiltration and oxidative stress.
The IMT and exercise training group (IMT group) will perform two daily IMT sessions of 30 breaths (< 5 minutes/session) during the pre-LTx period. IMT will start at 30% of MIP with a 5-10% weekly increase in training intensity guided by weekly MIP as tolerated (median weekly Borg dyspnea score < 7 during IMT until reaching 70% of MIP) and continued until LTx. In conjunction with their IMT program, IMT group participants will undergo exercise training at least three times per week as part of their usual care. The control group (exercise training group) will perform exercise training as part of their usual care three times per week for the duration of the waitlist period. The exercise regimen for both groups consists of aerobic, resistance, and flexibility training supervised by a physiotherapist approximately three times a week. The training includes a combination of in-person visits and home-based sessions. Both groups will also receive a respiratory endurance device to evaluate respiratory endurance throughout the trial.
IMT can improve respiratory muscle strength and endurance, potentially helping those who are candidates for LTx. In addition, studying patients undergoing LTx affords unique opportunities to investigate the mechanistic effects of IMT on diaphragm structure and function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pre-lung transplant candidates will be randomized to one of two groups: (1) IMT + exercise training; or (2) exercise training alone.
| Arm | Type | Receives |
|---|---|---|
| IMT and exercise training group | Experimental | Other: IMT and exercise training groupParticipants 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. |
| Usual care group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMT and exercise training groupParticipants 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. | Other | IMT and exercise training group |
Primary outcome
Study Recruitment According to Research Team Records
Time frame: Over study recruitment period (approximately 2 years)
Recruitment-success percentage in the study will be assessed based on research team study records.
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)
Participant retention will be assessed by measuring participant follow-up throughout the study period, according to research team records. A retention rate of 80% or greater (in each group) has been established as the criteria to determine study feasibility.
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)
Adherence to inspiratory muscle training will be assessed via the IMT training diary completed by participants. Successful adherence will be defined as completion of ≥ 80% training sessions.
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)
Adverse events and training side-effects (e.g., muscle soreness) with inspiratory muscle training will be monitored through participant training diaries during the study intervention period. The research coordinator will review these diaries with participants on a weekly basis. Additionally, participants will be strongly encouraged to promptly inform the study team if they experience any challenges with IMT.
Inspiratory Muscle Training Satisfaction Questionnaire (IMT Group Only)
Time frame: At 3 months post-transplant follow-up
Participant satisfaction and motivation with the IMT intervention will be determined using a satisfaction questionnaire.
19 secondary outcomes
Respiratory Muscle Endurance Test
Time frame: Change from baseline at 4 weeks, 8 weeks, 12 weeks, every 3 months until lung transplant (up to 24 months total), and 3 months post-transplant
Dyspnea Severity Assessed by Medical Research Council Dyspnea Scale
Time frame: Change from baseline at 4 weeks, 8 weeks, 12 weeks, every 3 months until lung transplant (up to 24 months total), and 3 months post-transplant
Qualitative Measures of Dyspnea Assessed by Qualitative Dyspnea Scale
Time frame: Change from baseline at 4 weeks, 8 weeks, 12 weeks, every 3 months until lung transplant (up to 24 months total), and 3 months post-transplant
Mood Assessed by Depression, Anxiety, and Stress Scale
Time frame: Change from baseline at 4 weeks, 8 weeks, 12 weeks, every 3 months until lung transplant (up to 24 months total), and 3 months post-transplant
Health-Related Quality of Life Assessed by St. George's Respiratory Questionnaire
Time frame: Change from baseline at 4 weeks, 8 weeks, 12 weeks, every 3 months until lung transplant (up to 24 months total), and 3 months post-transplant
Respiratory Muscle Strength Assessed by Maximal Inspiratory Pressure
Time frame: Change from baseline at 4 weeks, 8 weeks, 12 weeks, every 3 months until lung transplant (up to 24 months total), time of liberation from mechanical ventilation, and 3 months post-transplant
Physical Activity and Exercise Behaviors Assessed by International Physical Activity Questionnaire
Time frame: Change from baseline at 4 weeks, 8 weeks, 12 weeks, every 3 months until lung transplant (up to 24 months total), and 3 months post-transplant
Pulmonary Function Testing (Spirometry)
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, every 3 months until lung transplant (up to 24 months total), and 3 months post-transplant
Aerobic Endurance Assessed by the Six-Minute Walk Test
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, every 3 months until lung transplant (up to 24 months total), and 3 months post-transplant
Physical Function Assessed by the Short Physical Performance Battery
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, every 3 months until lung transplant (up to 24 months total), and 3 months post-transplant
Pre-Transplant Hospitalizations
Time frame: From baseline up until the time of admission for the index transplant hospitalization (up to 24 months total)
Peri-Transplant Mechanical Ventilation Bridging
Time frame: Peri-operative period, from time of index transplant hospital admission to time of transplant surgery (up to 24 months total)
Post-Transplant Duration of Mechanical Ventilation (Days)
Time frame: From time of transplant surgery to the time of liberation from mechanical ventilation (up to 3 months total)
WIND Weaning Classification
Time frame: At the time of liberation from mechanical ventilation following transplant surgery (up to 3 months total).
Post-Transplant Hospital Length of Stay (Days)
Time frame: From time of transplant surgery to the time of discharge from hospital (up to 3 months total).
Post-Transplant Discharge Disposition
Time frame: Time of discharge from index transplant hospitalization (up to 3 months total).
Primary Graft Dysfunction
Time frame: Up to 72 hours post-transplant
Post-Transplant Mortality
Time frame: Up to 90 days (3 months) post-transplant
Days Alive and at Home at 90 Days (DAAH90)
Time frame: Up to 90 days (3 months) post-transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Background: PubMed 25085497Weill D, Benden C, Corris PA, Dark JH, Davis RD, Keshavjee S, Lederer DJ, Mulligan MJ, Patterson GA, Singer LG, Snell GI, Verleden GM, Zamora MR, Glanville AR. A consensus document for the selection of lung transplant candidates: 2014--an update from the Pulmonary Transplantation Council of the International Society for Heart and Lung Transplantation. J Heart Lung Transplant. 2015 Jan;34(1):1-15. doi: 10.1016/j.healun.2014.06.014. Epub 2014 Jun 26.
- Background: PubMed 22283579Hook JL, Lederer DJ. Selecting lung transplant candidates: where do current guidelines fall short? Expert Rev Respir Med. 2012 Feb;6(1):51-61. doi: 10.1586/ers.11.83.
- Background: PubMed 26953218Fuehner T, Kuehn C, Welte T, Gottlieb J. ICU Care Before and After Lung Transplantation. Chest. 2016 Aug;150(2):442-50. doi: 10.1016/j.chest.2016.02.656. Epub 2016 Mar 4.
- Background: PubMed 15764726Christie JD, Kotloff RM, Ahya VN, Tino G, Pochettino A, Gaughan C, DeMissie E, Kimmel SE. The effect of primary graft dysfunction on survival after lung transplantation. Am J Respir Crit Care Med. 2005 Jun 1;171(11):1312-6. doi: 10.1164/rccm.200409-1243OC. Epub 2005 Mar 11.
- Background: PubMed 25084264Adler D, Dupuis-Lozeron E, Richard JC, Janssens JP, Brochard L. Does inspiratory muscle dysfunction predict readmission after intensive care unit discharge? Am J Respir Crit Care Med. 2014 Aug 1;190(3):347-50. doi: 10.1164/rccm.201404-0655LE. No abstract available.
- Background: PubMed 32074293Sklar MC, Dres M, Fan E, Rubenfeld GD, Scales DC, Herridge MS, Rittayamai N, Harhay MO, Reid WD, Tomlinson G, Rozenberg D, McClelland W, Riegler S, Slutsky AS, Brochard L, Ferguson ND, Goligher EC. Association of Low Baseline Diaphragm Muscle Mass With Prolonged Mechanical Ventilation and Mortality Among Critically Ill Adults. JAMA Netw Open. 2020 Feb 5;3(2):e1921520. doi: 10.1001/jamanetworkopen.2019.21520.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dmitry Rozenberg, MD, PhD principal investigator
University Health Network/University of Toronto
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMT and exercise training group in people with Inspiratory Muscle Training, run by University Health Network, Toronto at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dmitry Rozenberg, MD, PhD (416-340-4800 ext. 7358, Dmitry.Rozenberg@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study Recruitment According to Research Team Records (time frame: Over study recruitment period (approximately 2 years)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06370832, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.