Clinical trial NCT04826731: Effect of Respiratory Exerciser on Pulmonary Functions of COVID-19 Patients
Official title: Effect of Respiratory Exerciser on Pulmonary Functions of COVID-19 Patients, A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Respiratory Function Loss
Coronavirus Infection
Pneumonia, Viral
Keywords: Pulmonary Rehabilitation
Respiratory Function Loss
Lead sponsor: Diskapi Yildirim Beyazit Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2021-04-01
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be selected among those who apply to emergency service and evaluated by a pulmonary medicine resident or specialist. Among this population, further selection will be performed via the inclusion and exclusion criteria.

Brief 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.

Detailed description: SARS-CoV-2 is a novel coronavirus that is responsible for the current pandemic. Its clinical presentation varies from asymptomatic infection to severe respiratory failure requiring intensive care stay. Loss of respiratory function had been observed in survivors of other coronaviruses in earlier studies. The degree of respiratory function loss and if any intervention may reduce or prevent it remains an issue to be clarified.

The study's goal is to investigate the effects of pulmonary rehabilitation via a supporting device on COVID-19 patients during a follow-up period of one month. The primary method of investigation of pulmonary functions is comparing peak expiratory flow (PEF) at the time of diagnosis and after treatment.

The study hypothesizes that patients who had successfully used a respiratory exerciser or a similar aid device will have better PEF results at the end of the first-month evaluation.

The effect of an incentive spirometer and/or a respiratory exerciser on the pulmonary function results is the main element under investigation in this study. The hospital provides these devices, and in cases, patients demand another device, the patients and their relatives are asked to purchase such equipment.

Pulmonary function tests (PFT) are considered a part of routine evaluation for the COVID-19 patients a month after the treatment. Patients are considered suitable for PFT evaluation if the COVID-19 infectious process is deemed treated, and other contraindications for PFT are not present, such as recent surgery or pneumothorax.

Patients admitted to the pulmonary medicine ward for COVID-19 infection are generally those who already have respiratory comorbidity, including chronic obstructive pulmonary disease, asthma, concurrent pneumonia, and respiratory failure. Due to these reasons, PFT is not considered an acceptable evaluation method during the acute phase and is not requested. PEF testing, on the other hand, remains a simple yet effective alternative compared to PFT due to being more portable, the presence of disposable parts, and overall cost. It is the initial choice of evaluation for patients after a clinical response is seen to treatment and testing is deemed safe.

The respiratory exercise is considered a part of COVID-19 care, primarily due to patients' comorbidities, as mentioned above. This approach is limited in terms of healthcare personnel for on-point pulmonary rehabilitation due to both the disease's infectious nature and limited resources. Respiratory exercise devices are accepted as a reasonable alternative that can be quantitively monitored and provided on a daily basis.

This prospective study plans to evaluate the impact of respiratory exercise provided by incentive spirometers and respiratory exercisers. The evaluation will be performed by comparing the initial PEF result after the end of COVID-19 treatment and subsequent ward discharge; to the PEF result of the PFT evaluation at the end of the first month.

Eligibility criteria: Inclusion Criteria:

1. Being at least 18 years or older
2. Approval given both written and orally to the study participation
3. COVID-19 positivity proven by reverse transcription-polymerase chain reaction (RT-PCR) testing
4. At least one evaluation/consultation performed by a pulmonary medicine specialist OR admission to pulmonary medicine ward from another department in the hospital
5. First hospital admission has to be via emergency ward, regardless of the concurrent hospital stay.
6. Cooperation at an acceptable degree for pulmonary function testing.

Exclusion Criteria:

1. Any contraindication presence for pulmonary function testing (such as anatomic abnormalities, recent cardiac history, and severe respiratory failure)
2. Former COVID-19 history.
3. Persistent pulmonary or other systemic pathology (which prevents hospital discharge)
4. Refusal to participate in the monthly evaluation.
5. Persistent COVID-19 RT-PCR presence (which prevents PFT testing)
6. Known severe limitation in former PFT testing (FEV1 being lower than 30%)

Primary outcomes:
measure: Change in Peak Expiratory Flow (Absolute Value)
timeFrame: The first PEF testing will be performed seven days after initial diagnosis. The second testing will be performed one month after the hospital discharge, among those who are considered suitable for testing.
measure: Change in Peak Expiratory Flow (Percentage)
timeFrame: The first PEF testing will be performed seven days after initial diagnosis. The second testing will be performed one month after the hospital discharge, among those who are considered suitable for testing.
measure: Peak Expiratory Flow (Follow-up)
timeFrame: Testing for PEF results were performed at the follow-up evaluation, which was done 1 month post-baseline.
Secondary outcomes:
measure: Forced Expiratory Volume (FEV1)
timeFrame: Forced Expiratory Volume (FEV1) was evaluated at the follow-up evaluation, which was performed one-month post-baseline.
measure: Forced Vital Capacity (FVC)
timeFrame: Forced Vital Capacity was evaluated at the follow-up evaluation, which was performed 1 month post- baseline evaluation.
measure: Mortality
timeFrame: Mortality evaluation will include the time period of one month after hospital discharge. The total evaluation duration will also include the hospitalization period (which is considered an average of 7 days)
measure: Discharge to Follow-up Duration (Days)
timeFrame: The time frame for "Discharge to Follow-up Duration" consisted of up to two months post-baseline evaluation. When a patient had arrived for the first follow-up evaluation, the time difference between baseline evaluation and this re-evaluation was noted.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Dışkapı Yıldırım Beyazıt Training and Research Hospital Pulmonary Medicine Clinic
state: Çankaya
Study officials:
affiliation: Dışkapı Yıldırım Beyazıt Training and Research Hospital Pulmonary Medicine
name: Bahar Kurt, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Torres-Castro R, Vasconcello-Castillo L, Alsina-Restoy X, Solis-Navarro L, Burgos F, Puppo H, Vilaro J. Respiratory function in patients post-infection by COVID-19: a systematic review and meta-analysis. Pulmonology. 2021 Jul-Aug;27(4):328-337. doi: 10.1016/j.pulmoe.2020.10.013. Epub 2020 Nov 25.
citation: Gemicioglu B, Borekci S, Dilektasli AG, Ulubay G, Azap O, Saryal S. Turkish Thoracic Society Experts Consensus Report: Recommendations for Pulmonary Function Tests During and After COVID 19 Pandemic. Turk Thorac J. 2020 May;21(3):193-200. doi: 10.5152/TurkThoracJ.2020.20107.
citation: Mo X, Jian W, Su Z, Chen M, Peng H, Peng P, Lei C, Chen R, Zhong N, Li S. Abnormal pulmonary function in COVID-19 patients at time of hospital discharge. Eur Respir J. 2020 Jun 18;55(6):2001217. doi: 10.1183/13993003.01217-2020. Print 2020 Jun.
citation: Anastasio F, Barbuto S, Scarnecchia E, Cosma P, Fugagnoli A, Rossi G, Parravicini M, Parravicini P. Medium-term impact of COVID-19 on pulmonary function, functional capacity and quality of life. Eur Respir J. 2021 Sep 16;58(3):2004015. doi: 10.1183/13993003.04015-2020. Print 2021 Sep.