Inspiratory Muscle Training Immediately After Lung Transplantation

The Ohio State University

Status: Active, not recruiting

Conditions: Chronic Lung Disease; Rehabilitation; Muscle Weakness; Lung Transplantation

Treatments: Device: IMT- Placebo group; Device: IMT- Intervention group

Study type: Interventional

Funder types: Other

Identifiers

NCT05309551

2021H0310

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups

Inspiratory Muscle training- Intervention group

Experimental group

Description:

Along with standard post-transplant physical therapy, the intervention group will begin daily respiratory exercise training utilizing the IMT trainer device (POWERbreathe Medic Plus®) with weekly incremental increases in respiratory load. Patients will be asked to use the IMT device twice per day, 7 days per week, for 8 weeks.

Treatment:

Device: IMT- Intervention group

Inspiratory Muscle training - Placebo group

Sham Comparator group

Description:

Along with standard post-transplant physical therapy, the placebo group will begin daily respiratory exercise training utilizing the IMT trainer device (POWERbreathe Medic Plus®) with no increase of respiratory load. Patients will be asked to use the IMT device twice per day, 7 days per week, for 8 weeks.

Treatment:

Device: IMT- Placebo group

Usual care group

No Intervention group

Description:

Patients will only participate in standard post-transplant physical therapy.