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

NCT ID: NCT04978831

Last Updated: 2022-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2022-01-31

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.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease Breath Shortness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Respiratory exercise device group

Group Type EXPERIMENTAL

PEP Device

Intervention Type 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.

Reading aloud group

Group Type EXPERIMENTAL

Reading Aloud

Intervention Type OTHER

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.

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type OTHER

Other Intervention Names

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Smart Watch

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inonu University

OTHER

Sponsor Role lead

Responsible Party

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Gürkan ÖZDEN

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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İnönü University

Malatya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 29253921 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20588052 (View on PubMed)

Other Identifiers

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10368355

Identifier Type: -

Identifier Source: org_study_id

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