Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06370832
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-03-04
Brief Title:
Inspiratory Muscle Training in Lung Transplant Candidates
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Inspiratory Muscle Training in Lung Transplant Candidates and Implications on Early Post-Transplant Outcomes A Pilot and Feasibility Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 randomized clinical trial of IMT in LTx candidates in terms of recruitment rate retention program adherence safety and outcome ascertainment 2To establish whether IMT improves pre-transplant dyspnea perception diaphragm structure and function HRQoL and post-transplant ICU hospital and 3-month outcomes 3To 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 48 and 12 weeks and then every 3 months until transplant final assessment 3 months post-LTx
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 SocietyEuropean 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 randomized controlled trial
Objectives 1 To evaluate the feasibility of a randomized clinical trial of IMT in LTx candidates in terms of recruitment rate retention program adherence and outcome ascertainment with the use of self-reported questionnaires and data logs 2 To establish whether IMT improves pre-transplant dyspnea perception diaphragm structure and function HRQoL and post-transplant ICU hospital and 3-month clinical outcomes 3 To characterize the effect of pre-transplant IMT on peri-transplant diaphragm myofibrillar cross-sectional area oxidative capacity inflammatory markers and post-transplant diaphragm muscle thickness and function
Hypotheses 1 It will be feasible to recruit LTx candidates into an IMT program randomized control trial with a consent rate 30 enrolment rate of 3 patients per month adequate outcome ascertainment 80 and acceptable adherence 80 compliance with IMT sessions 2 IMT will increase respiratory muscle endurance duration 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 cross-sectional area 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 minutessession 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 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
The American Thoracic SocietyEuropean 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 randomized controlled trial
Objectives 1 To evaluate the feasibility of a randomized clinical trial of IMT in LTx candidates in terms of recruitment rate retention program adherence and outcome ascertainment with the use of self-reported questionnaires and data logs 2 To establish whether IMT improves pre-transplant dyspnea perception diaphragm structure and function HRQoL and post-transplant ICU hospital and 3-month clinical outcomes 3 To characterize the effect of pre-transplant IMT on peri-transplant diaphragm myofibrillar cross-sectional area oxidative capacity inflammatory markers and post-transplant diaphragm muscle thickness and function
Hypotheses 1 It will be feasible to recruit LTx candidates into an IMT program randomized control trial with a consent rate 30 enrolment rate of 3 patients per month adequate outcome ascertainment 80 and acceptable adherence 80 compliance with IMT sessions 2 IMT will increase respiratory muscle endurance duration 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 cross-sectional area 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 minutessession 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 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None