Unsupervised inspiratory muscle training for post-COVID-19 patients
Effects of Unsupervised Inspiratory Muscle Training on Ventilation Variability in Post-covid-19 Patients: Protocol for Randomized Clinical Trial.
This study is testing if a self-guided breathing exercise program can help people recovering from COVID-19 improve their breathing and overall well-being.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Universidade Federal do Rio Grande do Norte Academic / other |
| Locations | 2 sites (Natal, Rio Grande Do Norte and 1 other locations) |
| Trial ID | NCT06362499 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effects of an unsupervised inspiratory muscle training (IMT) protocol on ventilation variability in patients recovering from COVID-19. The study aims to assess how IMT can improve symptoms related to dysfunctional breathing and hypocapnia, which are common in these patients. Participants will undergo a series of assessments before and after a 6-week training period to measure changes in respiratory muscle strength, pulmonary function, quality of life, and functional capacity. The trial is randomized, controlled, and double-blind, ensuring unbiased results.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with a confirmed COVID-19 diagnosis and reduced respiratory muscle strength, without underlying respiratory or cardiac diseases.
Not a fit: Patients with severe health complications or those unable to participate in assessments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly alleviate respiratory symptoms and improve the quality of life for post-COVID-19 patients.
How similar studies have performed: While the specific approach of unsupervised IMT in post-COVID-19 patients is novel, similar interventions have shown promise in improving respiratory function in other populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects of both sexes will be included, with a diagnosis of COVID-19 confirmed by RT-PCR, aged over 18 years, without any underlying respiratory or cardiac disease and reduced respiratory muscle strength (≤100 cmH2O). Reduced inspiratory muscle strength will be defined using MIP. Exclusion Criteria: * Patients with conditions impairing assessments, health complications that justify interrupting data collection (e.g., syncope, intense chest pain, or cough with blood-tinged sputum), hospitalized due to exacerbation of clinical conditions, or requested to leave the study will be excluded.
Where this trial is running
Natal, Rio Grande Do Norte and 1 other locations
- Federal University of Rio Grande do Norte — Natal, Rio Grande Do Norte, Brazil (Recruiting)
- Patrícia Nogueira — Natal, Rio Grande Do Norte, Brazil (Recruiting)
Study contacts
- Principal investigator: Patrícia Nogueira — Universidade Federal do Rio Grande do Norte
- Study coordinator: Patrícia Nogueira, Principal
- Email: idpa02@hotmail.com
- Phone: +55 84 33422000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.