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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
90
The resistive load will be readjusted weekly to reach 50% of maximal inspiratory pressure (MIP).
The inspiratory resistive load will be adjusted to the minimum value of the device (9 cm H2O) during all inspiratory muscle training sessions.
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Change in inspiratory muscle strength: Maximal inspiratory pressure (MIP) measured in cmH2O
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.
Time frame: The groups will be assessed: Before Lung transplantation, at baseline (immediate post-transplant), 8 weeks, 6 and 12 months after LTX
Change in perceived dyspnea: Modified Medical Research Council Dyspnea Scale
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.
Time frame: The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX
Change in fatigue: Fatigue Severity Scale
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.
Time frame: The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX
Change in functional capacity
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
Time frame: The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX
Change in lung function: Pulmonary Function Test
Lung function will be measured in accordance with the guidelines of the American Thoracic Society. The following variables will be analyzed: (a) forced vital capacity (FVC, L) and (b) forced expiratory volume in the first second (FEV1, L).
Time frame: The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX
Change in physical performance
Physical performance test will be evaluated using the Short Physical Performance Battery Test (SPPB) to assess standing balance, walking speed, and chair stands. The corresponding score from each section is determined and compiled for an overall score of 0-12.
Time frame: The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX
Change in lower extremity muscle strength
Quadriceps strength will be measured with a hand-held dynamometer (HHD, Microfet®, Hogan Health Industries, Inc., UT, USA). At least three measurements will be obtained and the higher knee extensor muscle strength value will be used for the analysis.
Time frame: The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX
Change in grip strength
Grip strength will be performed using a digital dynamometer. At least three measurements will be obtained and the highest reproducible value will be taken into analysis and related to reference values.
Time frame: The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX
Change in quality of life
Heath related quality of life will be measured using the SF-36 questionnaire. The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life. The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH).
Time frame: The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX
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