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

Effect of Respiratory Exerciser on Pulmonary Functions of COVID-19 Patients, A Prospective Observational Study

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.

Study Overview

• Status: Completed
• Conditions: Coronavirus Infection; Pneumonia, Viral; Covid19; Respiratory Function Loss
• Intervention / Treatment: Other: Incentive Spirometer/Respiratory Exerciser

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.

• Study Type: Observational
• Enrollment (Actual): 14

Contacts and Locations

Study Locations

• Turkey
  • Çankaya
    • Ankara, Çankaya, Turkey, 06110
      • Dışkapı Yıldırım Beyazıt Training and Research Hospital Pulmonary Medicine Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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%)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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".	Other: 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.
Standard Care Group; Patients who did not use an incentive spirometer despite being suggested to do so will be categorized under "Standard Care Group".

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Peak Expiratory Flow (Absolute Value)	Two PEF results will be compared in the study. The first PEF testing will be performed by a handheld device and the second measurement will be performed either by an office spirometer or a handheld device. The priority will be given to the office spirometer for testing preference.	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.
Change in Peak Expiratory Flow (Percentage)	Two PEF results will be compared in the study. The first PEF testing will be performed by a handheld device and the second measurement will be performed either by an office spirometer or a handheld device. The priority will be given to the office spirometer for testing preference.	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.
Peak Expiratory Flow (Follow-up)	The Peak Expiratory Flow (PEF) results were obtained at the follow-up evaluation. These results were then compared with the initial baseline measurement of PEF performed at the hospital discharge.	Testing for PEF results were performed at the follow-up evaluation, which was done 1 month post-baseline.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced Expiratory Volume (FEV1)	Forced Expiratory Volume (FEV1) result of the pulmonary function testing was to be used as a pulmonary function parameter. It was performed via standard office spirometry. It was calculated as an absolute value (in liters) and as a percentage (compared to the normal population data) It was to be used as a validation method to ensure patients did not have a former yet undiagnosed respiratory disease and to validate the presence of abnormal Peak Expiratory Flow (PEF) values.	Forced Expiratory Volume (FEV1) was evaluated at the follow-up evaluation, which was performed one-month post-baseline.
Forced Vital Capacity (FVC)	Forced Vital Capacity (FVC) result of the pulmonary function testing was to be used as a pulmonary function parameter. It was performed via standard office spirometry. It was calculated as an absolute value (in liters) and as a percentage (compared to the normal population data) It was to be used as a validation method to ensure patients did not have a former yet undiagnosed respiratory disease and to validate the presence of abnormal Peak Expiratory Flow (PEF) values.	Forced Vital Capacity was evaluated at the follow-up evaluation, which was performed 1 month post- baseline evaluation.
Mortality	Mortality will be accepted as a secondary outcome measure, in patients who may not survive until the monthly evaluation for any reason.	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)
Discharge to Follow-up Duration (Days)	The duration between the baseline evaluation at the time of hospital discharge and the first follow-up is defined as "Discharge to Follow-up Duration". There happens a time difference between post-one month evaluation and this definition, due to appointment dates; the exact one month time for a patient happening to be within weekend days or due to delays in respiratory testing. This could be observed by the time range of patients given here, as some (as seen in patients arriving within 13 days) had come to the hospital earlier, while some ( in the other end of the group, such as those arriving at 41st day) had either arrived late or could not be evaluated with respiratory function testing due to appointment or testing issues up to the day mentioned.	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.

Collaborators and Investigators

• Sponsor: Diskapi Yildirim Beyazit Education and Research Hospital
• Investigators: Principal Investigator: Bahar Kurt, Professor, Dışkapı Yıldırım Beyazıt Training and Research Hospital Pulmonary Medicine

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: March 27, 2021
• First Submitted That Met QC Criteria: March 31, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): January 31, 2022
• Last Update Submitted That Met QC Criteria: January 27, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Pulmonary Rehabilitation; Respiratory Function Loss
• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections; Pneumonia, Viral
• Other Study ID Numbers: 104/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study protocol will be shared with other researchers working on a similar process, with proper credentials and acknowledgments given according to ICJME clinical trial registration policy. Signed Informed Consent Forms will only be shared with proper legal bodies and ethical committees in case of an ethical dilemma.
• IPD Sharing Time Frame: The data will be available for the 6 months after initial publication.
• IPD Sharing Access Criteria: The information mentioned above will be shared upon contact with the corresponding author. The criteria for data sharing would be that the researchers making the request would preferably seek a similar goal in the study proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No