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NCT05309551 · ClinicalTrials.gov registry record · NA
Inspiratory Muscle Training Immediately After Lung Transplantation
A NA study of Muscle Weakness and Rehabilitation, sponsored by Ohio State University.
- Active
- Registry status
- NA
- Development phase
- 90
- Enrollment target
- 1
- Study location
NCT05309551: Active NA study of Muscle Weakness and Rehabilitation, sponsored by Ohio State University.
NCT05309551 is a NA study of Muscle Weakness and Rehabilitation that is active but no longer recruiting, run by Ohio State University. The registered enrollment target is 90 participants, above the 71-participant average among 25 other Muscle Weakness trials with a reported enrollment target (27% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05309551, a NA study of Muscle Weakness and Rehabilitation, is active but no longer recruiting, sponsored by Ohio State University.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 90 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE IMT- Intervention group
- DEVICE IMT- Placebo group
Study Locations (1)
Ohio
- The Ohio State University Wexner Medical Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2022-04-20 |
| Est. Completion | 2026-05 |
| Phase | NA |
What the registry record for NCT05309551 still lists
NCT05309551 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, above the 71-participant average among 25 other Muscle Weakness trials with a reported enrollment target (27% higher).
The record links to 4 conditions, with Muscle Weakness appearing as the primary indexed condition, and to 2 interventions - of which IMT- Intervention group is the first listed.
NCT05309551 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT05309551 about?
NCT05309551 is a clinical study titled "Inspiratory Muscle Training Immediately After Lung Transplantation". 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 i...
What is the current status of trial NCT05309551?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 90 participants. The study started on 2022-04-20. Estimated completion is 2026-05.
What conditions does trial NCT05309551 study?
This clinical trial studies the following conditions: Muscle Weakness, Rehabilitation, Lung Transplantation, Chronic Lung Disease.
What interventions are being tested in trial NCT05309551?
The interventions under investigation include: IMT- Intervention group (DEVICE), IMT- Placebo group (DEVICE).
Who is sponsoring clinical trial NCT05309551?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05309551 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05309551's enrollment target sits among peer trials
90 5th of 25 higher than 21 of 25 other Muscle Weakness trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Muscle Weakness trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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