Inspiratory Muscle Training in Lung Transplant Candidates and Implications on Early Post-Transplant Outcomes: A Pilot and Feasibility Multicenter Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 5
- 主要终点
- Study Recruitment According to Research Team Records
研究概览
简要总结
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).
详细描述
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.
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.
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Ascertainment of post-transplant clinical outcomes (including histopathology assessments) will be blinded by assessors to study group up to 3 months post-transplant.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Study Recruitment According to Research Team Records
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: At 3 months post-transplant follow-up
Participant satisfaction and motivation with the IMT intervention will be determined using a satisfaction questionnaire.
次要结局
- Pre-Transplant Hospitalizations(From baseline up until the time of admission for the index transplant hospitalization (up to 24 months total))
- Respiratory Muscle Endurance Test(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(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(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(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(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(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(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)(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(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(Baseline, 4 weeks, 8 weeks, 12 weeks, every 3 months until lung transplant (up to 24 months total), and 3 months post-transplant)
- Peri-Transplant Mechanical Ventilation Bridging(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)(From time of transplant surgery to the time of liberation from mechanical ventilation (up to 3 months total))
- WIND Weaning Classification(At the time of liberation from mechanical ventilation following transplant surgery (up to 3 months total).)
- Post-Transplant Hospital Length of Stay (Days)(From time of transplant surgery to the time of discharge from hospital (up to 3 months total).)
- Post-Transplant Discharge Disposition(Time of discharge from index transplant hospitalization (up to 3 months total).)
- Primary Graft Dysfunction(Up to 72 hours post-transplant)
- Post-Transplant Mortality(Up to 90 days (3 months) post-transplant)
- Days Alive and at Home at 90 Days (DAAH90)(Up to 90 days (3 months) post-transplant)