Clinical trial NCT05309551: Inspiratory Muscle Training Immediately After Lung Transplantation
Official title: The Effects of Inspiratory Muscle Training Immediatley After Lung Transplantation: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lung Transplantation
Chronic Lung Disease
Muscle Weakness
Rehabilitation
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Already participating in a regular IMT program
* Impaired cognition with inability to follow commands

Primary outcomes:
measure: Change in inspiratory muscle strength: Maximal inspiratory pressure (MIP) measured in cmH2O
timeFrame: The groups will be assessed: Before Lung transplantation, at baseline (immediate post-transplant), 8 weeks, 6 and 12 months after LTX
measure: Change in perceived dyspnea: Modified Medical Research Council Dyspnea Scale
timeFrame: The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX
measure: Change in fatigue: Fatigue Severity Scale
timeFrame: The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX
measure: Change in functional capacity
timeFrame: The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX
Secondary outcomes:
measure: Change in lung function: Pulmonary Function Test
timeFrame: The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX
measure: Change in physical performance
timeFrame: The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX
measure: Change in lower extremity muscle strength
timeFrame: The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX
measure: Change in grip strength
timeFrame: The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX
measure: Change in quality of life
timeFrame: The groups will be assessed: Before Lung transplantation, 8 weeks, 6 and 12 months after LTX
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: School of Health and Rehabilitation Sciences- Physical Therapy Division
name: Cristiane Meirelles, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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