Bubble PEP Training Among Patient With Chronic Obstructiv... | NCT04828837

Description Module

Detailed Description

This study aimed to explore the effectiveness of cough and sputum assessment and respiratory physiological indicators after training with the Bubble positive expiratory pressure (Bubble PEP) inpatients with COPD. This is a randomization control trial design survey using convenient sampling and will be to select 94 inpatients with COPD in the division of chest ward of two teaching hospital in New Taipei City. The subjects who meet the conditions for admission are explained, and they need to sign a consent form confirming that they understand the risks. More, they are randomly divided into the experimental group (experimental group n=47) and the control group (control group n=47). The experimental group receives the Bubble PEP training; the control group receives the division of chest ward routine care. The study employs a structured questionnaire including a basic demography, COPD domain, COPD assessment test (CAT), cough and sputum assessment test, and check the peak expiratory flow rate (PEFR) using it for data collection. The study needs to be approve by the Institutional Review Board. The two groups agreed to participate in the study, after completing the subject consent form before the intervention, they also received the pre-test as a benchmark for the intervention effect. After completing the 7-day and 30-day intervention, the post-test was performed immediately to understand the intervention immediate effect.

Label	Type	Description	Intervention Names
Bubble positive expiratory pressure training	Experimental	The experimental group receives the Bubble PEP training.	Device: bubble PEP
general care	No Intervention	The control group receives the division of chest ward routine care.

Name	Type	Description	Arm Group Labels	Other Names
bubble PEP	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Chinese Version of Chronic Obstructive Pulmonary Disease Assessment Test(CAT)	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.	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.
The Cough With Sputum Symptoms Assessment Questionnaire(CSSAQ)	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.	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.
Peak Expiratory Flow Rate(PEFR)	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.	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.

Secondary Outcomes

Measure	Description	Time Frame
Re-hospitalization Event	The number of patients who were readmitted due to COPD acute exacerbation (COPDAE) within 14 days after discharge during the study.	Within 14 days after discharge.

Name	Affiliation	Role
Szu Yi Wang	none, specify Unaffiliated	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
National Taipei University of Nursing and Heath Sciences		Taipei	Beitou District	112303	Taiwan

ID	Title	Description
FG000	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.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 25, 2021	Jul 29, 2022

ID	Title	Description
BG000	Bubble Positive Expiratory Pressure Training	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
BG001	General Care	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
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00013 BG00114 BG00227

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

Age : < 70

Title	Measurements
	BG0006 BG0014 BG00210

Age : >= 70

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0001 BG0011 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Taiwan

Title	Measurements
	BG00013 BG00114 BG002

Marital status

Count of Participants

Participants

Title

Denominators

Categories

divorced/Single

Title	Measurements
	BG0005 BG0014 BG002

Occupation

Blue-collar workers are individuals who perform hard manual labor in sectors such as agriculture, manufacturing, construction, mining, or maintenance.

White-collar workers are typically found in office settings, characterized by their professional attire, often including white-collared shirts.

Count of Participants

Participants

Title

Denominators

Categories

blue-collar worker

Title	Measurements
	BG0007 BG001

Smoking history

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
smoking	BG0003 BG0014 BG002

Chronic comorbidities

Count of Participants

Participants

Title

Denominators

Categories

Hypertension

Title	Measurements
	BG0006 BG0017 BG002

COPD Grade

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
GOLD 2(FEV1 50-79)	BG0002 BG0016 BG002

Dry powder bronchodilator use (day)

Mean

Standard Deviation

days

Title

Denominators

Categories

Title	Measurements
	BG0007.25± 4.31 BG0013.30± 2.41 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

The Chinese Version of Chronic Obstructive Pulmonary Disease Assessment Test(CAT)

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.

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.

Posted

Mean

Standard Deviation

score on a scale

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.

ID	Title	Description
OG000	General Care Group	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.
OG001	Intervention Group	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.

Units	Counts
Participants	OG00014 OG00113

Title

Denominators

Categories

- ParticipantsOG00014
- ParticipantsOG00113

Title	Measurements
	OG00013± 6.33

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Descriptive statistics, including count, percentage, mean, and standard deviation, were used to summarize the data.	Wilcoxon (Mann-Whitney)		<0.05	We used Mann-Whitney U test for independent samples, and Fisher's exact tests when more than 20% of cells have expected frequencies <5 or less than 10 observations to examine the homogeneity between groups based on demographic characteristics.	Mean Difference (Final Values)	0.39			2-Sided	95							Superiority	The intervention effect was evaluated using the generalized estimating equation (GEE) statistical method. Two-tailed tests were conducted, and p-values less than .05 were considered statistically significant.

Primary

The Cough With Sputum Symptoms Assessment Questionnaire(CSSAQ)

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.

Posted

Mean

Standard Deviation

score on a scale

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.

ID	Title	Description
OG000	Bubble Positive Expiratory Pressure Training	A total of 13 participants were enrolled in the intervention group and completed the baseline C (T0). After 7 days, in the second round, 11 participants completed the CASSAQ 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.

Primary

Peak Expiratory Flow Rate(PEFR)

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.

Posted

Mean

Standard Deviation

ml/sec

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.

ID	Title	Description
OG000	Bubble Positive Expiratory Pressure Training	A total of 13 participants were enrolled in the intervention group and completed the baseline PEFR (T0). After 7 days, in the second round, 11 participants completed the PEFR 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.

Secondary

Re-hospitalization Event

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

Posted

Number

Within 14 days after discharge.

ID	Title	Description
OG000	Bubble Positive Expiratory Pressure Training	During the study, no patients in the experimental group were readmitted due to COPD acute exacerbation within 14 days after discharge.
OG001	General Care	During the study, no patients in the control group were readmitted due to COPD acute exacerbation within 14 days after discharge.

Units	Counts
Participants	OG000

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Bubble Positive Expiratory Pressure Training	Denied any adverse event in the experimental group.	0	13	0	13	0	13
EG001	General Care	Denied any adverse event in the control group.	0	14	0	14	0	14