Effect of Respiratory Exerciser on Pulmonary Functions of COVID-19 Patients

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-01

Study Completion Date

2021-07-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Covid19 Respiratory Function Loss Coronavirus Infection Pneumonia, Viral

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Incentive Spirometer Group

Patients who would use an incentive spirometer, in addition to standard care provided to COVID-19 patients, will be categorized under "Incentive Spirometer Group".

Incentive Spirometer/Respiratory Exerciser

Intervention Type OTHER

A patient is considered acceptable for the "Incentive Spirometer Group" if the patient can use an incentive spirometer and/or a respiratory exerciser at least four times per day. A pulmonary medicine specialist will confirm the proper usage of the device.

Standard Care Group

Patients who did not use an incentive spirometer despite being suggested to do so will be categorized under "Standard Care Group".

No interventions assigned to this group

Interventions

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Incentive Spirometer/Respiratory Exerciser

A patient is considered acceptable for the "Incentive Spirometer Group" if the patient can use an incentive spirometer and/or a respiratory exerciser at least four times per day. A pulmonary medicine specialist will confirm the proper usage of the device.

Intervention Type OTHER

Eligibility Criteria

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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%)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No