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

Not Applicable

Completed

• Conditions: Breath Shortness; Chronic Obstructive Pulmonary Disease
• Interventions: Other: Reading Aloud; Device: PEP Device

• Registration Number: NCT04978831
• Lead Sponsor: Inonu University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-01
• Study First Submitted: 2021-07-17
• Study First Submitted QC: 2021-07-17
• Study First Posted: 2021-07-27
• Primary Completion: 2022-01-03
• Study Completion: 2022-01-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-28
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reading aloud group	Reading Aloud	-
Respiratory exercise device group	PEP Device	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

İnönü University; 🇹🇷 Malatya, Turkey