Coronavirus Infection, Covid19, Pneumonia, Viral, Respiratory Function Loss
Conditions
Keywords
Pulmonary Rehabilitation, Respiratory Function Loss
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.
Interventions
OTHERIncentive 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.
Sponsors
Diskapi Yildirim Beyazit Education and Research Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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%)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Peak Expiratory Flow (Absolute Value) | 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. | 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. |
| Change in Peak Expiratory Flow (Percentage) | 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. | 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. |
| Peak Expiratory Flow (Follow-up) | Testing for PEF results were performed at the follow-up evaluation, which was done 1 month post-baseline. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Forced Expiratory Volume (FEV1) | Forced Expiratory Volume (FEV1) was evaluated at the follow-up evaluation, which was performed one-month post-baseline. | 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. |
| 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. | 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. |
| Forced Vital Capacity (FVC) | Forced Vital Capacity was evaluated at the follow-up evaluation, which was performed 1 month post- baseline evaluation. | 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. |
| 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) | Mortality will be accepted as a secondary outcome measure, in patients who may not survive until the monthly evaluation for any reason. |
Countries
Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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: 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. | 10 |
| Standard Care Group Patients who did not use an incentive spirometer despite being suggested to do so will be categorized under Standard Care Group. | 4 |
| Total | 14 |
Baseline characteristics
| Characteristic | Incentive Spirometer Group | Standard Care Group | Total |
|---|---|---|---|
| Age, Continuous | 54 Years | 41 Years | 51 Years |
| Charlson Comorbidity Index | 1 Units on a scale | 0 Units on a scale | 1 Units on a scale |
| Discharge Oxygenation Requirement Mask | 0 Participants | 0 Participants | 0 Participants |
| Discharge Oxygenation Requirement Nasal | 2 Participants | 0 Participants | 2 Participants |
| Discharge Oxygenation Requirement None | 8 Participants | 4 Participants | 12 Participants |
| Discharge to Follow-up Duration (Days) | 31 Days | 30 Days | 30 Days |
| Hospitalization Duration (Days) | 10 Days | 5 Days | 8 Days |
| Initial Oxygenation Requirement Mask | 2 Participants | 1 Participants | 3 Participants |
| Initial Oxygenation Requirement Nasal | 4 Participants | 2 Participants | 6 Participants |
| Initial Oxygenation Requirement None | 4 Participants | 1 Participants | 5 Participants |
| Maximum Oxygenation Requirement High Flow | 1 Participants | 0 Participants | 1 Participants |
| Maximum Oxygenation Requirement Mask | 3 Participants | 1 Participants | 4 Participants |
| Maximum Oxygenation Requirement Nasal | 6 Participants | 2 Participants | 8 Participants |
| Maximum Oxygenation Requirement None | 0 Participants | 1 Participants | 1 Participants |
| Peak Expiratory Flow (Hospital Discharge) | 80 ml/min | 100 ml/min | 86 ml/min |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Turkey | 10 Participants | 4 Participants | 14 Participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 7 Participants | 2 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 4 |
| other Total, other adverse events | 0 / 10 | 0 / 4 |
| serious Total, serious adverse events | 0 / 10 | 0 / 4 |
Outcome results
Primary
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.
Time frame: 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.
Population: Initially, all fourteen patients were accepted as the study group, among those four patients who could not utilize the respiratory exerciser device were later moved to the standard care group.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Incentive Spirometer Group | Change in Peak Expiratory Flow (Absolute Value) | 175 ml/min |
| Standard Care Group | Change in Peak Expiratory Flow (Absolute Value) | 160 ml/min |
Comparison: Nonparametric testing was utilized due to non-standard distribution and reduced sample size. Comparison between groups was made by Mann-Whitney U testing. Spearman's rho was utilized for correlation analysis. No subgroup analyses were planned for the study.p-value: 0.374Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: 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.
Population: Initially, all fourteen patients were accepted as the study group, among those four patients who could not utilize the respiratory exerciser device were later moved to the standard care group.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Incentive Spirometer Group | Change in Peak Expiratory Flow (Percentage) | 70 Percentage of Predicted Value |
| Standard Care Group | Change in Peak Expiratory Flow (Percentage) | 51 Percentage of Predicted Value |
Comparison: Nonparametric testing was utilized due to non-standard distribution and reduced sample size. Comparison between groups was made by Mann-Whitney U testing. Spearman's rho was utilized for correlation analysis. No subgroup analyses were planned for the study.p-value: 0.635Wilcoxon (Mann-Whitney)
Primary
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.
Time frame: Testing for PEF results were performed at the follow-up evaluation, which was done 1 month post-baseline.
Population: Initially, all fourteen patients were accepted as the study group, afterwards, those who had refused to or could not cooperate with the respiratory exerciser were accepted as the standard care group.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Incentive Spirometer Group | Peak Expiratory Flow (Follow-up) | 400 ml/min |
| Standard Care Group | Peak Expiratory Flow (Follow-up) | 500 ml/min |
Secondary
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.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Incentive Spirometer Group | Discharge to Follow-up Duration (Days) | 31 Days |
| Standard Care Group | Discharge to Follow-up Duration (Days) | 5 Days |
Secondary
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.
Time frame: Forced Expiratory Volume (FEV1) was evaluated at the follow-up evaluation, which was performed one-month post-baseline.
Population: Due to cooperation difficulties and/or differences above 10% in repeated testing, a total of 6 patients were excluded from the FEV1 evaluation.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Incentive Spirometer Group | Forced Expiratory Volume (FEV1) | 70 Percentage of Predicted Value |
| Standard Care Group | Forced Expiratory Volume (FEV1) | 100 Percentage of Predicted Value |
Secondary
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.
Time frame: Forced Vital Capacity was evaluated at the follow-up evaluation, which was performed 1 month post- baseline evaluation.
Population: Due to cooperation difficulties and/or differences above 10% in repeated testing, a total of 6 patients were excluded from the FVC evaluation.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Incentive Spirometer Group | Forced Vital Capacity (FVC) | 80 Percentage of Predicted Value |
| Standard Care Group | Forced Vital Capacity (FVC) | 95 Percentage of Predicted Value |
Secondary
Mortality
Mortality will be accepted as a secondary outcome measure, in patients who may not survive until the monthly evaluation for any reason.
Time frame: 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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Incentive Spirometer Group | Mortality | 0 Participants |
| Standard Care Group | Mortality | 0 Participants |