Inspiratory Muscle Training Immediately After Lung Transplantation

StatusActive, Not Recruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 9 months later May 2026 → Mar 2027
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Record History

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  1. Primary completion pushed from May 2026 to Mar 2027 Show 4 more changesShow less
    • Study completion pushed from May 2026 to Oct 2027
    • Secondary endpoints: details revised at 5 of 5 entries
    • Publications: details revised at 11 of 12 entries
    • Eligibility criteria expanded, about 5 words
  2. Primary and study completion dates: Feb 2026 to May 2026v5
  3. Primary completion date: Jul 2024 to Feb 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Dec 2024 to Feb 2026
    • Site details revised
    v4
  4. Primary completion date: Dec 2023 to Jul 2024
    • Interventions: PowerBreathe Medic- Intervention group (Device), Powerbreathe Medic- Placebo group (Device) to IMT- Intervention group (Device), IMT- Placebo group (Device)
    v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Apr 2022 to Apr 20, 2022
    • Secondary endpoints: details revised at 1 of 5 entries
    v2
  6. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05309551
Lead Sponsor Ohio State University
Conditions
(from sponsor)		 Lung Transplantation, Chronic Lung Disease, Muscle Weakness, Rehabilitation
Related terms Muscle Weakness
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov