Trial Outcomes & Findings for Effect of Respiratory Exerciser on Pulmonary Functions of COVID-19 Patients (NCT NCT04826731)

Last Updated: 2022-01-31

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

14 participants

Primary outcome 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.

Results posted on

2022-01-31

Participant Flow

Participant milestones

Participant milestones
Measure	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.	Standard Care Group Patients who did not use an incentive spirometer despite being suggested to do so will be categorized under "Standard Care Group".
Overall Study STARTED	10	4
Overall Study COMPLETED	10	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Incentive Spirometer Group n=10 Participants 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.	Standard Care Group n=4 Participants Patients who did not use an incentive spirometer despite being suggested to do so will be categorized under "Standard Care Group".	Total n=14 Participants Total of all reporting groups
Age, Continuous	54 Years n=10 Participants	41 Years n=4 Participants	51 Years n=14 Participants
Sex: Female, Male Female	3 Participants n=10 Participants	2 Participants n=4 Participants	5 Participants n=14 Participants
Sex: Female, Male Male	7 Participants n=10 Participants	2 Participants n=4 Participants	9 Participants n=14 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Turkey	10 Participants n=10 Participants	4 Participants n=4 Participants	14 Participants n=14 Participants
Charlson Comorbidity Index	1 Units on a scale n=10 Participants	0 Units on a scale n=4 Participants	1 Units on a scale n=14 Participants
Peak Expiratory Flow (Hospital Discharge)	80 ml/min n=10 Participants	100 ml/min n=4 Participants	86 ml/min n=14 Participants
Initial Oxygenation Requirement None	4 Participants n=10 Participants	1 Participants n=4 Participants	5 Participants n=14 Participants
Initial Oxygenation Requirement Nasal	4 Participants n=10 Participants	2 Participants n=4 Participants	6 Participants n=14 Participants
Initial Oxygenation Requirement Mask	2 Participants n=10 Participants	1 Participants n=4 Participants	3 Participants n=14 Participants
Maximum Oxygenation Requirement None	0 Participants n=10 Participants	1 Participants n=4 Participants	1 Participants n=14 Participants
Maximum Oxygenation Requirement Nasal	6 Participants n=10 Participants	2 Participants n=4 Participants	8 Participants n=14 Participants
Maximum Oxygenation Requirement Mask	3 Participants n=10 Participants	1 Participants n=4 Participants	4 Participants n=14 Participants
Maximum Oxygenation Requirement High Flow	1 Participants n=10 Participants	0 Participants n=4 Participants	1 Participants n=14 Participants
Discharge Oxygenation Requirement None	8 Participants n=10 Participants	4 Participants n=4 Participants	12 Participants n=14 Participants
Discharge Oxygenation Requirement Nasal	2 Participants n=10 Participants	0 Participants n=4 Participants	2 Participants n=14 Participants
Discharge Oxygenation Requirement Mask	0 Participants n=10 Participants	0 Participants n=4 Participants	0 Participants n=14 Participants
Hospitalization Duration (Days)	10 Days n=10 Participants	5 Days n=4 Participants	8 Days n=14 Participants
Discharge to Follow-up Duration (Days)	31 Days n=10 Participants	30 Days n=4 Participants	30 Days n=14 Participants

PRIMARY outcome

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.

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.

Outcome measures

Outcome measures
Measure	Incentive Spirometer Group n=10 Participants 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.	Standard Care Group n=4 Participants Patients who did not use an incentive spirometer despite being suggested to do so will be categorized under "Standard Care Group".
Change in Peak Expiratory Flow (Absolute Value)	175 ml/min Interval 40.0 to 320.0	160 ml/min Interval 10.0 to 430.0

PRIMARY outcome

Outcome measures

Outcome measures
Measure	Incentive Spirometer Group n=10 Participants 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.	Standard Care Group n=4 Participants Patients who did not use an incentive spirometer despite being suggested to do so will be categorized under "Standard Care Group".
Change in Peak Expiratory Flow (Percentage)	70 Percentage of Predicted Value Interval 27.0 to 178.0	51 Percentage of Predicted Value Interval 4.0 to 239.0

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Incentive Spirometer Group n=10 Participants 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.	Standard Care Group n=4 Participants Patients who did not use an incentive spirometer despite being suggested to do so will be categorized under "Standard Care Group".
Peak Expiratory Flow (Follow-up)	400 ml/min Interval 190.0 to 540.0	500 ml/min Interval 260.0 to 610.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Incentive Spirometer Group n=7 Participants 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.	Standard Care Group n=3 Participants Patients who did not use an incentive spirometer despite being suggested to do so will be categorized under "Standard Care Group".
Forced Expiratory Volume (FEV1)	70 Percentage of Predicted Value Interval 59.0 to 127.0	100 Percentage of Predicted Value Interval 60.0 to 105.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Incentive Spirometer Group n=7 Participants 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.	Standard Care Group n=3 Participants Patients who did not use an incentive spirometer despite being suggested to do so will be categorized under "Standard Care Group".
Forced Vital Capacity (FVC)	80 Percentage of Predicted Value Interval 52.0 to 123.0	95 Percentage of Predicted Value Interval 58.0 to 103.0

SECONDARY outcome

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)

Mortality will be accepted as a secondary outcome measure, in patients who may not survive until the monthly evaluation for any reason.

Outcome measures

Outcome measures
Measure	Incentive Spirometer Group n=10 Participants 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.	Standard Care Group n=4 Participants Patients who did not use an incentive spirometer despite being suggested to do so will be categorized under "Standard Care Group".
Mortality	0 Participants	0 Participants

SECONDARY outcome

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.

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.

Outcome measures

Outcome measures
Measure	Incentive Spirometer Group n=10 Participants 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.	Standard Care Group n=4 Participants Patients who did not use an incentive spirometer despite being suggested to do so will be categorized under "Standard Care Group".
Discharge to Follow-up Duration (Days)	31 Days Interval 13.0 to 41.0	5 Days Interval 3.0 to 13.0

Adverse Events

Incentive Spirometer Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Care Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kerem Ensarioğlu

Ankara Sanatoryum Training and Research Hospital

Phone: 905426142727

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place