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NCT06330376 · ClinicalTrials.gov registry record · NA
Diaphragmatic Breathing Exercises for Post-COVID-19 Diaphragmatic Dysfunction (DD)
A NA study of Post Acute Sequelae of COVID-19, sponsored by University of Minnesota.
- Completed
- Registry status
- NA
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT06330376 is a NA study of Post Acute Sequelae of COVID-19 that has completed, run by University of Minnesota. The registered enrollment target is 16 participants, below the 185-participant average among 8 other Post Acute Sequelae of COVID-19 trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06330376, a NA study of Post Acute Sequelae of COVID-19, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- NA
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
Diaphragm is the principal muscle of inspiration. Diaphragmatic dysfunction is seen in many conditions including following intubation, lung disease, prolonged ventilation, neuromuscular disease, phrenic nerve injury. The possible mechanisms of diaphragmatic dysfunction in patients with COVID19 are critical illness myopathy, ventilator-induced diaphragm dysfunction, iatrogenic phrenic nerve injury particularly secondary to line placement, post-infectious inflammatory neuropathy of the phrenic nerve, or possibly direct neuromuscular involvement of the SARS- CoV-2 virus given expression of the angiotensin- converting enzyme 2 (ACE2) receptor in the peripheral nervous system and skeletal muscle. The use of diaphragmatic ultrasound has been widely used to assess diaphragmatic function is well known in patients following prolonged mechanical ventilation. Prolonged mechanical ventilation leads to contractile dysfunction of respiratory muscles, in particular the diaphragm, causing a so-called ventilator-induced diaphragm dysfunction. The latter is defined as a loss of diaphragm force-generating capacity specifically related to the use of mechanical ventilation. However, the use of diaphragmatic Ultrasound to assess its function in Long COVID patients has not been noted and is a gap in the work up of these patients. The purpose of this study is to address Diaphragmatic Dysfunctional (DD) breathing seen in patients with Post-Acute Sequelae of COVID-19 (PASC), which results in shortness of breath/chest tightness and subsequent fatigue. Targeting shortness of breath and subsequent fatigue as a central symptom of PASC will alleviate long term sequelae for the patients with PASC. DD will be addressed by a unique intervention of physical therapy. The goal of this prospective randomized clinical study will be to evaluate the comparative treatment effect of DB on markers, specifically fatigue, dyspnea, 6 min walk test, depression/anxiety, and quality of life (QoL).
Conditions Studied
Interventions
- OTHER Usual care of traditional treatment
- OTHER Specific DB program/Diaphragmatic manipulation program
Study Locations (1)
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2024-03-01 |
| Est. Completion | 2025-08-15 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06330376
The ClinicalTrials.gov registry entry for NCT06330376 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 185-participant average among 8 other Post Acute Sequelae of COVID-19 trials with a reported enrollment target (91% lower). The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Post Acute Sequelae of COVID-19 appearing as the primary indexed condition, and to 2 interventions - of which Usual care of traditional treatment is the first listed.
NCT06330376 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT06330376 about?
NCT06330376 is a clinical study titled "Diaphragmatic Breathing Exercises for Post-COVID-19 Diaphragmatic Dysfunction (DD)". Diaphragm is the principal muscle of inspiration. Diaphragmatic dysfunction is seen in many conditions including following intubation, lung disease, prolonged ventilation, neuromuscular disease, phrenic nerve injury. The possible mechanisms of diaphragmatic dysfunction in patients with COVID19 are c...
What is the current status of trial NCT06330376?
This trial is currently completed. It is a NA study. The enrollment target is 16 participants. The study started on 2024-03-01. Estimated completion is 2025-08-15.
What conditions does trial NCT06330376 study?
This clinical trial studies the following conditions: Post Acute Sequelae of COVID-19.
What interventions are being tested in trial NCT06330376?
The interventions under investigation include: Usual care of traditional treatment (OTHER), Specific DB program/Diaphragmatic manipulation program (OTHER).
Who is sponsoring clinical trial NCT06330376?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06330376 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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