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

Primary Purpose

Chronic Obstructive Pulmonary Disease With Exacerbation, Chronic Obstructive Pulmonary Disease Exacerbation, Chronic Pulmonary Disease

Status
Terminated
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
bubble PEP
Sponsored by
National Taipei University of Nursing and Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease With Exacerbation focused on measuring COPD, Bubble PEP, pulmonary function

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Hospitalized patients diagnosed with COPD
  2. Over 40 years old
  3. Awareness and ability to read articles
  4. Agree to participate in this research and sign the research consent form

Exclusion Criteria:

  1. Use non-invasive positive pressure breathing apparatus
  2. Have received positive pressure breathing therapy before or during hospitalization
  3. People with mental illness
  4. Coughing up blood, pneumothorax
  5. Suffer from legally infectious respiratory diseases
  6. Pregnant women
  7. Reject the subject

Sites / Locations

  • National Taipei University of Nursing and Heath Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Bubble positive expiratory pressure training

general care

Arm Description

The experimental group receives the Bubble PEP training.

The control group receives the division of chest ward routine care.

Outcomes

Primary Outcome Measures

Pulmonary function
I hope the breathing exercise can to improving the COPDAE in-patients pulmonary function. I would like to use two kinds of questionnaires and a total of 43 questions, and PEFR to monitor pulmonary function, which includes the efficacy of cough improvement, sputum clearance, and airway obstruction symptoms. Furthermore, I will follow up to study one day, the 7th, and the 30th day.

Secondary Outcome Measures

Re-hospitalization risk
I hope the breathing exercise can reduce the chronic obstructive pulmonary disease acute exacerbation in-patients the re-hospitalization risk. Therefore, I will follow the patient every week between discharge till the 30th day.

Full Information

First Posted
February 25, 2021
Last Updated
April 6, 2022
Sponsor
National Taipei University of Nursing and Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04828837
Brief Title
Bubble PEP Training Among Patient With Chronic Obstructive Pulmonary Disease in Pulmonary Function Effects
Official Title
National Taipei University of Nursing and Heath Sciences
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
Due to the SARS-CoV-2 pandemic in Taiwan in 2021/05, and then recruitment was stopped under the government epidemic prevention policy.
Study Start Date
February 2, 2021 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taipei University of Nursing and Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The morbidity rate of Chronic Obstructive Pulmonary Disease (COPD) is increasing year by year. It is predicted to be the third leading cause of death worldwide in 2030. People with COPD have a high risk of needing a ventilator due to the decline of lung function, the increase of secretions, the dysfunction of airway clearance, and the obstruction and loss of alveolar elasticity.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease With Exacerbation, Chronic Obstructive Pulmonary Disease Exacerbation, Chronic Pulmonary Disease
Keywords
COPD, Bubble PEP, pulmonary function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bubble positive expiratory pressure training
Arm Type
Experimental
Arm Description
The experimental group receives the Bubble PEP training.
Arm Title
general care
Arm Type
No Intervention
Arm Description
The control group receives the division of chest ward routine care.
Intervention Type
Device
Intervention Name(s)
bubble PEP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pulmonary function
Description
I hope the breathing exercise can to improving the COPDAE in-patients pulmonary function. I would like to use two kinds of questionnaires and a total of 43 questions, and PEFR to monitor pulmonary function, which includes the efficacy of cough improvement, sputum clearance, and airway obstruction symptoms. Furthermore, I will follow up to study one day, the 7th, and the 30th day.
Time Frame
for one year
Secondary Outcome Measure Information:
Title
Re-hospitalization risk
Description
I hope the breathing exercise can reduce the chronic obstructive pulmonary disease acute exacerbation in-patients the re-hospitalization risk. Therefore, I will follow the patient every week between discharge till the 30th day.
Time Frame
for one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hospitalized patients diagnosed with COPD Over 40 years old Awareness and ability to read articles Agree to participate in this research and sign the research consent form Exclusion Criteria: Use non-invasive positive pressure breathing apparatus Have received positive pressure breathing therapy before or during hospitalization People with mental illness Coughing up blood, pneumothorax Suffer from legally infectious respiratory diseases Pregnant women Reject the subject
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Szu Yi Wang
Organizational Affiliation
none, specify Unaffiliated
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taipei University of Nursing and Heath Sciences
City
Taipei City
State/Province
Beitou District
ZIP/Postal Code
112303
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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