The Effects of Inspiratory Muscle Training Immediatley After Lung Transplantation: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change in perceived dyspnea: Modified Medical Research Council Dyspnea Scale
研究概览
简要总结
Following lung transplantation (LTX), patients may exhibit respiratory and skeletal muscle weakness that will affect exercise capacity, increase dyspnea and fatigue, limit activities of daily living (ADL) and decrease quality of life.
Inspiratory muscle training (IMT) has been extensively studied in a variety of non-LTX populations and research has shown that IMT improves exercise capacity, diaphragmatic thickness, and reduced dyspnea during activities of daily living and improved quality of life in patients with advanced lung disease.
The aim of this randomized controlled study is to investigate the benefits of providing inspiratory muscle training via use of an inspiratory muscle trainer device in addition to standard physical therapy in the acute phase of rehabilitation following LTX. Patients targeted for enrollment will be those with any type of advanced lung disease requiring LTX with the objective of demonstrating improvements in respiratory muscle recovery, perceived dyspnea, severity of fatigue, and overall functional status following the transplant procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant has personally signed and dated informed consent form indicating understanding of all pertinent aspects of the study
- •Active on the waiting list for lung transplantation
- •Able to ambulate pre-transplant (not bed/wheelchair bound) with or without assistive device
排除标准
- •Already participating in a regular IMT program
- •Impaired cognition with inability to follow commands
结局指标
主要结局
Change in perceived dyspnea: Modified Medical Research Council Dyspnea Scale
时间窗: The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX
Modified Medical Research Council Dyspnea Scale (mMRC) will measure dyspnea perceptions during the activities of daily living. A score from 0-4 is used to classify the impact of dyspnea on physical function in patients with respiratory limitations. 0 represents a person who suffers from dyspnea only with strenuous exercise. 4 represents a person who are too breathless to leave the house, or breathless when dressing.
Change in functional capacity
时间窗: The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX
Functional capacity will be estimated using the 6-minute walk test according to the American Thoracic Society guidelines. Before and after the test, oxygen saturation (SpO2), heart rate, Modified Dyspnea Borg Scale and walking distance will be recorded
Change in inspiratory muscle strength: Maximal inspiratory pressure (MIP) measured in cmH2O
时间窗: The groups will be assessed: Before Lung transplantation, at baseline (immediate post-transplant), 8 weeks, 6 and 12 months after LTX
Inspiratory muscle strength will be measured as maximal inspiratory pressure (MIP) using a POWERbreathe® KH2, International Ltd; UK. The MIP is defined as the greatest negative pressure sustained for at least one second by each patient. The patient will be verbally encouraged to perform three to five inspiratory maneuvers at maximal intensity. The maximum value will be used for the analysis.
Change in fatigue: Fatigue Severity Scale
时间窗: The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX
Fatigue Severity Scale (FSS) evaluates fatigue using a nine-item, self-scored questionnaire, which with a visual ranking format ranging from one to seven that quantifies patient-perceived fatigue. Higher composite scores indicate more severe fatigue. An average score of less than 2.8 indicates no fatigue, and more than 6.1 indicates chronic fatigue syndrome.
次要结局
- Change in lung function: Pulmonary Function Test(The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX)
- Change in grip strength(The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX)
- Change in quality of life(The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX)
- Change in physical performance(The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX)
- Change in lower extremity muscle strength(The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX)
研究者
Cristiane Meirelles, PT, PhD
Associate Professor-Clinical
Ohio State University