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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Obstructive Pulmonary Disease, Breath Shortness

Intervention / Treatment
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* Device: PEP Device
* Other: Reading Aloud


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Respiratory exercise device group<br> | Device: PEP Device<br>* 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.<br>* Other names: Smart Watch;|
| Experimental: Reading aloud group<br> | Other: Reading Aloud<br>* 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.<br>|
| No Intervention: Control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary Function Parameters | Change in FEV1/FVC ratio will be evaluated with pulmonary function test | 2 month | 
| 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. | 2 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Fatigue, Breath exercise, Reading aloud