Trial Outcomes & Findings for Bubble PEP Training Among Patient With Chronic Obstructive Pulmonary Disease in Pulmonary Function Effects (NCT NCT04828837)

Last Updated: 2024-12-11

Results Overview

In the CAT, a total of eight items were used to assess the degree of dyspnea of the patients. Each item had a score ranging from 0 to 5 points, with the lowest total score being 0 points and the highest total score being 40 points. The higher the score, the higher the degree of dyspnea.

Recruitment status

TERMINATED

Study phase

Target enrollment

57 participants

Primary outcome timeframe

The pre-tests within 48 hours of hospitalization, which served as the baseline of the intervention (T0). Assessed at 1(T1) and 4(T2) weeks, week 4 was reported.

Results posted on

2024-12-11

Participant Flow

The study data were collected from February 2021 to July 2021 at two teaching hospitals in northern Taiwan.

In the study, 30 patients were excluded from the study before assignment to groups4 patients declined to participate, 10 inpatients had used non-invasive PEP treatment before hospitalization, 4 patients has a mental illness, and 12 patients have notifiable respiratory infectious diseases.

Participant milestones

Participant milestones
Measure	Bubble Positive Expiratory Pressure Training The experimental group receives the Bubble PEP training. bubble PEP: Using the bubble positive expiratory pressure (Bubble PEP) for breathing training of inpatients with COPD. The training course for one day of three times. Every time needs about 20 mins. Huff and cough after the breathing training the end.	General Care The control group receives the division of chest ward routine care.
Overall Study STARTED	13	14
Overall Study COMPLETED	8	4
Overall Study NOT COMPLETED	5	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Bubble Positive Expiratory Pressure Training The experimental group receives the Bubble PEP training. bubble PEP: Using the bubble positive expiratory pressure (Bubble PEP) for breathing training of inpatients with COPD. The training course for one day of three times. Every time needs about 20 mins. Huff and cough after the breathing training the end.	General Care The control group receives the division of chest ward routine care.
Overall Study Stay-at-home during a COVID-19 outbreak	1	3
Overall Study Lost to Follow-up	2	6
Overall Study Lack of Efficacy	1	0
Overall Study Admitted due to pneumothorax.	1	0
Overall Study Admitted due to HIVD for operation.	0	1

Baseline Characteristics

Bubble PEP Training Among Patient With Chronic Obstructive Pulmonary Disease in Pulmonary Function Effects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bubble Positive Expiratory Pressure Training n=13 Participants GOLD: Global Initiative for Chronic Obstructive Lung Disease; a Baseline (T0) data conduct homogenous test; Fisher's exact: Gander, Age, Marital status, Occupation, Smoking history, chronic comorbidities, diabetes mellitus, pneumothorax, lung cancer, COPD Grade	General Care n=14 Participants GOLD: Global Initiative for Chronic Obstructive Lung Disease; a Baseline (T0) data conduct homogenous test; Fisher's exact: Gander, Age, Marital status, Occupation, Smoking history, chronic comorbidities, diabetes mellitus, pneumothorax, lung cancer, COPD Grade	Total n=27 Participants Total of all reporting groups
Age, Customized Age : < 70	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Age, Customized Age : >= 70	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Taiwan	13 participants n=5 Participants	14 participants n=7 Participants	27 participants n=5 Participants
Marital status divorced/Single	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Marital status married	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Occupation blue-collar worker	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Occupation white-collar worker	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Smoking history smoking	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Smoking history non-smoking	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Smoking history quit-smoking	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Chronic comorbidities Hypertension	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Chronic comorbidities Diabetes mellitus	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Chronic comorbidities Heart disease	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Chronic comorbidities Pneumothorax	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Chronic comorbidities Lung cancer	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
COPD Grade GOLD 2(FEV1 50-79)	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
COPD Grade GOLD 3(FEV1 30-49)	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Dry powder bronchodilator use (day)	7.25 days STANDARD_DEVIATION 4.31 • n=5 Participants	3.30 days STANDARD_DEVIATION 2.41 • n=7 Participants	5.45 days STANDARD_DEVIATION 4.0 • n=5 Participants

PRIMARY outcome

Timeframe: The pre-tests within 48 hours of hospitalization, which served as the baseline of the intervention (T0). Assessed at 1(T1) and 4(T2) weeks, week 4 was reported.

Population: A total of 57 were randomly assigned and complete test, with 13 in the experimental group and 14 in the control group. At T1, the experimental group had 11 analyzed, experiencing a total loss of 2 participants. In comparison, the control group had 6 analyzed at T1, with a cumulative loss of 8 participants. Moving to T2, the experimental group had 8 analyzed, with a total loss of 3 participants. The control group had 4 analyzed at T2, with a cumulative loss of 2 participants.

Outcome measures

Outcome measures
Measure	General Care Group n=14 Participants A total of 14 participants were enrolled in the control group and completed the baseline CAT (T0). After 7 days, in the second round, 6 participants completed the CAT T1 assessment. Five participants refused to participate in the breathing training, one participant was hospitalized for treatment due to a herniated disc, and one participant was unable to complete the T1 assessment as they stayed at home during the COVID-19 outbreak. After a 30-day study period, in the third round (T2), 6 participants completed the assessment. Two participants did not complete the third assessment. Among the participants who did not complete the third assessment, one individual refused further breathing training, and one individual stayed at home during the COVID-19 outbreak.	Intervention Group n=13 Participants A total of 13 participants were enrolled in the intervention group and completed the baseline CAT (T0). After 7 days, in the second round, 11 participants completed the CAT T1 assessment. Two participants were unable to complete the T2 assessment due to their inability to learn breathing techniques. After a 30-day study period, in the third round (T2), 8 participants completed the assessment. Among the participants who did not complete the third assessment, one individual refused to participate in the breathing training, one was hospitalized due to spontaneous pneumothorax, and one stayed at home during the COVID-19 outbreak.
The Chinese Version of Chronic Obstructive Pulmonary Disease Assessment Test(CAT) T1	11.17 score on a scale Standard Deviation 8.04	13.18 score on a scale Standard Deviation 10.59
The Chinese Version of Chronic Obstructive Pulmonary Disease Assessment Test(CAT) T2	9.50 score on a scale Standard Deviation 9.26	9.63 score on a scale Standard Deviation 6.78
The Chinese Version of Chronic Obstructive Pulmonary Disease Assessment Test(CAT) T0	13 score on a scale Standard Deviation 6.33	19.77 score on a scale Standard Deviation 6.26

PRIMARY outcome

Timeframe: The pre-tests within 48 hours of hospitalization, which served as the baseline of the intervention (T0). Assessed at 1(T1) and 4(T2) weeks, week 4 was reported.

CSSAQ is used to assess patients' cough and sputum symptoms. The questionnaire content is based on published literature. It consists of 25 questions, including issues related to cough, sputum, and psychological symptoms and impacts. The scoring uses a four-point Likert scale, with scores ranging from 0 to 4, where higher scores indicate more severe symptoms. The total scale score ranges from a minimum of 0 to a maximum of 100. The content validity index is 1, and the Cronbach's α is 0.97.

Outcome measures

Outcome measures
Measure	General Care Group n=13 Participants A total of 14 participants were enrolled in the control group and completed the baseline CAT (T0). After 7 days, in the second round, 6 participants completed the CAT T1 assessment. Five participants refused to participate in the breathing training, one participant was hospitalized for treatment due to a herniated disc, and one participant was unable to complete the T1 assessment as they stayed at home during the COVID-19 outbreak. After a 30-day study period, in the third round (T2), 6 participants completed the assessment. Two participants did not complete the third assessment. Among the participants who did not complete the third assessment, one individual refused further breathing training, and one individual stayed at home during the COVID-19 outbreak.	Intervention Group n=14 Participants A total of 13 participants were enrolled in the intervention group and completed the baseline CAT (T0). After 7 days, in the second round, 11 participants completed the CAT T1 assessment. Two participants were unable to complete the T2 assessment due to their inability to learn breathing techniques. After a 30-day study period, in the third round (T2), 8 participants completed the assessment. Among the participants who did not complete the third assessment, one individual refused to participate in the breathing training, one was hospitalized due to spontaneous pneumothorax, and one stayed at home during the COVID-19 outbreak.
The Cough With Sputum Symptoms Assessment Questionnaire(CSSAQ) T0	14.38 score on a scale Standard Deviation 10.46	27.00 score on a scale Standard Deviation 23.31
The Cough With Sputum Symptoms Assessment Questionnaire(CSSAQ) T1	23.64 score on a scale Standard Deviation 20.92	29.83 score on a scale Standard Deviation 28.34
The Cough With Sputum Symptoms Assessment Questionnaire(CSSAQ) T2	14.38 score on a scale Standard Deviation 10.46	27.00 score on a scale Standard Deviation 23.31

PRIMARY outcome

Timeframe: The study lasted 30 days with a total of three measurements. The first measurement baseline was 48 hours after hospitalization, the second on day 7 of the study, and the third on day 30 of the study.

The TruZone peak flow meter is used to monitor the patient's Forced Expiratory Volume in the first second (FEV1). For each data collection session, three maximum expiratory flow tests are conducted, and the best value is taken as the result for that session. The measurement unit is ml/sec.

Outcome measures

Outcome measures
Measure	General Care Group n=13 Participants A total of 14 participants were enrolled in the control group and completed the baseline CAT (T0). After 7 days, in the second round, 6 participants completed the CAT T1 assessment. Five participants refused to participate in the breathing training, one participant was hospitalized for treatment due to a herniated disc, and one participant was unable to complete the T1 assessment as they stayed at home during the COVID-19 outbreak. After a 30-day study period, in the third round (T2), 6 participants completed the assessment. Two participants did not complete the third assessment. Among the participants who did not complete the third assessment, one individual refused further breathing training, and one individual stayed at home during the COVID-19 outbreak.	Intervention Group n=14 Participants A total of 13 participants were enrolled in the intervention group and completed the baseline CAT (T0). After 7 days, in the second round, 11 participants completed the CAT T1 assessment. Two participants were unable to complete the T2 assessment due to their inability to learn breathing techniques. After a 30-day study period, in the third round (T2), 8 participants completed the assessment. Among the participants who did not complete the third assessment, one individual refused to participate in the breathing training, one was hospitalized due to spontaneous pneumothorax, and one stayed at home during the COVID-19 outbreak.
Peak Expiratory Flow Rate(PEFR) T0	320.00 ml/sec Standard Deviation 94.57	232.50 ml/sec Standard Deviation 85.00
Peak Expiratory Flow Rate(PEFR) T1	250.45 ml/sec Standard Deviation 82.60	273.33 ml/sec Standard Deviation 89.14
Peak Expiratory Flow Rate(PEFR) T2	320.00 ml/sec Standard Deviation 94.57	232.50 ml/sec Standard Deviation 85.00

SECONDARY outcome

Timeframe: Within 14 days after discharge.

The number of patients who were readmitted due to COPD acute exacerbation (COPDAE) within 14 days after discharge during the study.

Outcome measures

Outcome measures
Measure	General Care Group n=8 Participants A total of 14 participants were enrolled in the control group and completed the baseline CAT (T0). After 7 days, in the second round, 6 participants completed the CAT T1 assessment. Five participants refused to participate in the breathing training, one participant was hospitalized for treatment due to a herniated disc, and one participant was unable to complete the T1 assessment as they stayed at home during the COVID-19 outbreak. After a 30-day study period, in the third round (T2), 6 participants completed the assessment. Two participants did not complete the third assessment. Among the participants who did not complete the third assessment, one individual refused further breathing training, and one individual stayed at home during the COVID-19 outbreak.	Intervention Group n=6 Participants A total of 13 participants were enrolled in the intervention group and completed the baseline CAT (T0). After 7 days, in the second round, 11 participants completed the CAT T1 assessment. Two participants were unable to complete the T2 assessment due to their inability to learn breathing techniques. After a 30-day study period, in the third round (T2), 8 participants completed the assessment. Among the participants who did not complete the third assessment, one individual refused to participate in the breathing training, one was hospitalized due to spontaneous pneumothorax, and one stayed at home during the COVID-19 outbreak.
Re-hospitalization Event rehospitalization event	0 Number	0 Number
Re-hospitalization Event non rehospitalization event	8 Number	6 Number

Adverse Events

Bubble Positive Expiratory Pressure Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

General Care

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

Wang Szu-Yi

NTUNHS

Phone: 886-97140315

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place