NCT05309551

Inspiratory Muscle Training Immediately After Lung Transplantation

The Effects of Inspiratory Muscle Training Immediatley After Lung Transplantation: a Randomized Controlled Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Transplantation
• Chronic Lung Disease
• Muscle Weakness
• Rehabilitation

Interventions

Type	Name	Description
DEVICE	IMT- Intervention group	The resistive load will be readjusted weekly to reach 50% of maximal inspiratory pressure (MIP).
DEVICE	IMT- Placebo group	The inspiratory resistive load will be adjusted to the minimum value of the device (9 cm H2O) during all inspiratory muscle training sessions.

Timeline

• Start date: 2022-04-20
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2022-04-04
• Last updated: 2025-12-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study