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

Sponsor

Inonu University (Other)

Overall Status

Completed

CT.gov ID

NCT04978831

Collaborator

(none)

131

Enrollment

Location

Arms

Actual Duration (Months)

8.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease Breath Shortness	Device: PEP Device Other: Reading Aloud	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

131 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Nov 1, 2020

Actual Primary Completion Date :

Jan 3, 2022

Actual Study Completion Date :

Jan 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Respiratory exercise device group	Device: PEP Device 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. Other Names: Smart Watch
Experimental: Reading aloud group	Other: Reading Aloud 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.
No Intervention: Control group

Arm

Intervention/Treatment

Experimental: Respiratory exercise device group

Device: PEP Device

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.

Other Names:

Smart Watch

Experimental: Reading aloud group

Other: Reading Aloud

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.

No Intervention: Control group

Outcome Measures

Primary Outcome Measures

Pulmonary Function Parameters [2 month]
Change in FEV1/FVC ratio will be evaluated with pulmonary function test
Fatigue [2 month]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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