N/A
N=14
Effect of Respiratory Exerciser on Pulmonary Functions of COVID-19 Patients
Covid19 · Respiratory Function Loss · Coronavirus Infection · Pneumonia, Viral
Bottom Line
View on ClinicalTrials.gov: NCT04826731 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcome: Primary: Change in Peak Expiratory Flow (Absolute Value) — 175; 160 ml/min — p=0.374
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Incentive Spirometer/Respiratory Exerciser (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Peak Expiratory Flow (Absolute Value) |
175; 160 | 0.374 |
| PRIMARY Change in Peak Expiratory Flow (Percentage) |
70; 51 | 0.635 |
| PRIMARY Peak Expiratory Flow (Follow-up) |
400; 500 | — |
| SECONDARY Forced Expiratory Volume (FEV1) |
70; 100 | — |
| SECONDARY Forced Vital Capacity (FVC) |
80; 95 | — |
| SECONDARY Mortality |
0; 0 | — |
| SECONDARY Discharge to Follow-up Duration (Days) |
31; 5 | — |
Summary
COVID-19 infection is the cause of the current pandemic, responsible for loss of life and disability at a rate unseen before. Among survivors, the infection may cause lasting damage, such as permanent loss of lung function.
This study aims to investigate if pulmonary rehabilitation done via supportive devices may reduce or prevent lung function injury. Patients will be chosen among COVID-19 patients who require hospitalization. Patients then will be divided into two groups, those who had used said devices, and compare them to those who had not used them for any reason. After a month, two groups will be evaluated by respiratory function tests, which are expected to provide the results required for a proper comparison.
Pulmonary rehabilitation provided by the supportive devices is expected to either lessen or eliminate a loss of pulmonary function over time, compared to the group who did not use them.
Eligibility Criteria
Inclusion Criteria
- Being at least 18 years or older
- Approval given both written and orally to the study participation
- COVID-19 positivity proven by reverse transcription-polymerase chain reaction (RT-PCR) testing
- At least one evaluation/consultation performed by a pulmonary medicine specialist OR admission to pulmonary medicine ward from another department in the hospital
- First hospital admission has to be via emergency ward, regardless of the concurrent hospital stay.
- Cooperation at an acceptable degree for pulmonary function testing.
Exclusion Criteria
- Any contraindication presence for pulmonary function testing (such as anatomic abnormalities, recent cardiac history, and severe respiratory failure)
- Former COVID-19 history.
- Persistent pulmonary or other systemic pathology (which prevents hospital discharge)
- Refusal to participate in the monthly evaluation.
- Persistent COVID-19 RT-PCR presence (which prevents PFT testing)
- Known severe limitation in former PFT testing (FEV1 being lower than 30%)
Data sourced from ClinicalTrials.gov (NCT04826731). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.