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Completed

NCT Number: NCT04978831

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Breath Shortness Chronic Disease Disease Attributes Dyspnea Fatigue Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

İnönü University

Malatya, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PEP Device

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

Reading Aloud

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.

Primary outcomes

  1. Pulmonary Function Parameters

    Time frame: 2 month

    Change in FEV1/FVC ratio will be evaluated with pulmonary function test

  2. Fatigue

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 27, 2021
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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