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

NCT04826731 | Completed Results

• 1 other identifier: 104/18
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Respiratory Function Loss; Coronavirus Infection; Pneumonia, Viral

Keywords

Pulmonary Rehabilitation; Respiratory Function Loss

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Forced Expiratory Volume (FEV1)

  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 was evaluated at the follow-up evaluation, which was performed 1 month post- baseline evaluation.

• Mortality

  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 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.

Study Arms (2)

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

Standard Care Group

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

Interventions

Incentive Spirometer/Respiratory Exerciser 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.

Incentive Spirometer Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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%)

Sponsors & Collaborators

• Diskapi Yildirim Beyazit Education and Research Hospital: lead

Study Sites (1)

Dışkapı Yıldırım Beyazıt Training and Research Hospital Pulmonary Medicine Clinic

Ankara, Çankaya, 06110, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 33262076 BACKGROUND

• 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.

  PMID: 32584237 BACKGROUND

• 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.

  PMID: 32381497 BACKGROUND

• 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.

  PMID: 33574080 BACKGROUND

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Pneumonia, Viral

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

All patients (n=84) admitted to the ward between these dates were evaluated for the study. Thirty-five patients were found suitable for the study. More than half of the suitable patients (n=21) refused to participate and thus were excluded from the study. This unexpected refusal to participation was the main limitation of the study.

Results Point of Contact

• Title: Dr. Kerem Ensarioğlu
• Organization: Ankara Sanatoryum Training and Research Hospital

kerem.ensarioglu@gmail.com

905426142727

Study Officials

• Bahar Kurt, Professor

  Dışkapı Yıldırım Beyazıt Training and Research Hospital Pulmonary Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: March 27, 2021
• First Posted: April 1, 2021
• Study Start: April 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: July 1, 2021
• Last Updated: January 31, 2022
• Results First Posted: January 31, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The data will be available for the 6 months after initial publication.
• 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.

Locations

TU (1)