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The Effect of Use of Breathing Exercise Device and Reading Aloud on Vital Signs

Primary Purpose

Chronic Obstructive Pulmonary Disease, Breath Shortness

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
PEP Device
Reading Aloud
Sponsored by
Inonu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Fatigue, Breath exercise, Reading aloud

Eligibility Criteria

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

Inclusion Criteria:

  • Having been diagnosed with COPD for at least 6 months or before
  • Not having a respiratory system defect caused by diseases other than COPD
  • Not in the GOLD-4 COPD stage
  • Being able to read and write Turkish
  • Have no problems communicating or speaking
  • Being able to use basic information technologies
  • Using a smartphone
  • Having an active internet connection

Exclusion Criteria:

  • Having non-COPD pulmonary problems and diagnosed cardiovascular disease
  • Not volunteering to participate in the study
  • Having a psychiatric disorder such as schizophrenia or dementia that disrupts the thought process

Sites / Locations

  • İnönü University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Respiratory exercise device group

Reading aloud group

Control group

Arm Description

Outcomes

Primary Outcome Measures

Pulmonary Function Parameters
Change in FEV1/FVC ratio will be evaluated with pulmonary function test
Fatigue
The COPD and Asthma Fatigue Scale was developed by Revicki et al in 2010 to reveal the effect of COPD and Asthma on fatigue. The items of the questions in the scale, which consists of 12 questions in total, are graded with a 5-point Likert type as "never", "rarely", "sometimes", "often", "very often". A total of 12 to 60 points is obtained from the scale. A single score is obtained from the scale for the state of fatigue, and there is no evaluation of the sub-dimensions. An increase in this score indicates that the person's fatigue level is high.

Secondary Outcome Measures

Full Information

First Posted
July 17, 2021
Last Updated
March 28, 2022
Sponsor
Inonu University
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1. Study Identification

Unique Protocol Identification Number
NCT04978831
Brief Title
The Effect of Use of Breathing Exercise Device and Reading Aloud on Vital Signs
Official Title
The Effect of Use of Breathing Exercise Device and Reading Aloud on Vital Signs, Fatigue and Pulmonary Function Parameters in Patients With COPD Who Followed Up by Wearable Technology
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
January 3, 2022 (Actual)
Study Completion Date
January 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inonu University

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
Purpose of the research; To determine the effects of wearable technology follow-up, breathing exercises with a breathing exercise device and reading aloud on vital signs, fatigue and respiratory function parameters in individuals with COPD. This research will be conducted using a randomized controlled trial model. "Personal Description Form", "COPD and Asthma Fatigue Scale", Visual Analog Scale and pulmonary function tests will be used in data collection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Breath Shortness
Keywords
COPD, Fatigue, Breath exercise, Reading aloud

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
131 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Respiratory exercise device group
Arm Type
Experimental
Arm Title
Reading aloud group
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
PEP Device
Other Intervention Name(s)
Smart Watch
Intervention Description
The breathing exercise device is a device that simulates pursed-lip breathing by creating positive expiratory pressure (PEP). Before starting to use the device, it will be explained that they need to put the mouthpiece on the device and put the nose clip on their nose, and the participants will be shown how it is done. The device will be used at 5 cmH2O pressure. A single exercise session consists of 3 exercise cycles, and a single exercise cycle consists of 15 breathing-exhalation activities. Participants will complete 3 cycles (a total of 45 inhales and exhales) in a single session. 1 loop lying on the left side, 1 loop lying on the right side, and 1 loop in sitting upright position. Participants held these sessions in the morning, afternoon, and evening. After completing each cycle, the participants will remove their nose clips and cough 2-3 times. Each participant will perform a total of 135 breathing exercises in one day.
Intervention Type
Other
Intervention Name(s)
Reading Aloud
Intervention Description
The patients in this group were given a book that they chose from among the book types within the scope of the study, according to their wishes. For the selection of books, opinions were taken from the experts in the education faculty of the same university and it was stated that any book separation was not important. The books that the participants wanted to read were provided by the researcher. They were asked to read this book aloud during the day, sitting upright on a chair or sofa, for 15 minutes, three times a day. They were able to stop reading when the participant was tired or felt too short of breath to continue reading.
Primary Outcome Measure Information:
Title
Pulmonary Function Parameters
Description
Change in FEV1/FVC ratio will be evaluated with pulmonary function test
Time Frame
2 month
Title
Fatigue
Description
The COPD and Asthma Fatigue Scale was developed by Revicki et al in 2010 to reveal the effect of COPD and Asthma on fatigue. The items of the questions in the scale, which consists of 12 questions in total, are graded with a 5-point Likert type as "never", "rarely", "sometimes", "often", "very often". A total of 12 to 60 points is obtained from the scale. A single score is obtained from the scale for the state of fatigue, and there is no evaluation of the sub-dimensions. An increase in this score indicates that the person's fatigue level is high.
Time Frame
2 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Having been diagnosed with COPD for at least 6 months or before Not having a respiratory system defect caused by diseases other than COPD Not in the GOLD-4 COPD stage Being able to read and write Turkish Have no problems communicating or speaking Being able to use basic information technologies Using a smartphone Having an active internet connection Exclusion Criteria: Having non-COPD pulmonary problems and diagnosed cardiovascular disease Not volunteering to participate in the study Having a psychiatric disorder such as schizophrenia or dementia that disrupts the thought process
Facility Information:
Facility Name
İnönü University
City
Malatya
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29253921
Citation
McNamara RJ, Epsley C, Coren E, McKeough ZJ. Singing for adults with chronic obstructive pulmonary disease (COPD). Cochrane Database Syst Rev. 2017 Dec 19;12(12):CD012296. doi: 10.1002/14651858.CD012296.pub2.
Results Reference
background
PubMed Identifier
20588052
Citation
Wang YT, Green JR, Nip IS, Kent RD, Kent JF. Breath group analysis for reading and spontaneous speech in healthy adults. Folia Phoniatr Logop. 2010;62(6):297-302. doi: 10.1159/000316976. Epub 2010 Jun 28.
Results Reference
background

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The Effect of Use of Breathing Exercise Device and Reading Aloud on Vital Signs

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