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Breathibg Exercises and Inhaler Trainingfor Chronic Obstructive Pulmonary Disease (COPD) Patients (COPD)

Primary Purpose

COPD, Breathlessness, Aerocele

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Inhaler training
Breathing exercises
Sponsored by
Kirsehir Ahi Evran Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for COPD focused on measuring COPD, Inhaler training, Breathing Exercises, Dyspnea, Quality of Life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The individuals over the age of 18,
  • Who had been diagnosed with COPD for at least three months,
  • Using inhalers at least twice a day,
  • Misusing their drug,
  • Had not previously taken breathing exercise training
  • Had not participated in a rehabilitation program

Exclusion Criteria:

  • Mental disorders,
  • Communication disabilities,
  • Heart disease that could lead to dyspnea,
  • Unstable angina

Sites / Locations

  • Kırşehir Ahi Evran University Faculty of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Breathing exercise and inhaler training

inhaler training

Arm Description

This group were given pursed lip breathing exercise and inhaler training.

This group were given only inhaler training

Outcomes

Primary Outcome Measures

Patient Information Form
Consisted of 19 questions including sociodemographic and disease features of the patients
Breathing Exercise and Inhaler Application Skill Chart
Consisted of 18 items including the steps of breathing exercises and inhaler utilization to be applied to breathing exercises and inhaler group.
Inhaler Application Skill Chart
Consisted of 10 items including only the skill of applying inhaler to be applied to the both group. Correct steps were evaluated as 1 point and wrong steps as 0 points. It was administered to patients when they were first enrolled in the study and when they came for control four weeks later.
COPD assessment test (CAT)
The scale developed by Jones et al. (2009) is used to measure the health status of individuals with COPD.
St. George's respiratory questionnaire (SGRQ)
It is a quality of life questionnaire specific to patients with COPD developed by Jones and Forde (2008).
Modified medical research council (mMRC)
It was developed by the British Medical Research Council in order to provide information about the degree of dyspnea experienced by the patient based on the patient's activity and the patient's perception of the disease. As it is a one-dimensional scale Cronbach's α coefficient could not be calculated.

Secondary Outcome Measures

COPD assessment test (CAT)
The scale developed by Jones et al. (2009) is used to measure the health status of individuals with COPD.
Breathing Exercise and Inhaler Application Skill Chart
Consisted of 18 items including the steps of breathing exercises and inhaler utilization to be applied to breathing exercises and inhaler group.
Inhaler Application Skill Chart
Consisted of 10 items including only the skill of applying inhaler to be applied to the both group. Correct steps were evaluated as 1 point and wrong steps as 0 points. It was administered to patients when they were first enrolled in the study and when they came for control four weeks later.
St. George's respiratory questionnaire (SGRQ)
It is a quality of life questionnaire specific to patients with COPD developed by Jones and Forde (2008).
Modified medical research council (mMRC)
It was developed by the British Medical Research Council in order to provide information about the degree of dyspnea experienced by the patient based on the patient's activity and the patient's perception of the disease. As it is a one-dimensional scale Cronbach's α coefficient could not be calculated.

Full Information

First Posted
January 5, 2021
Last Updated
February 3, 2021
Sponsor
Kirsehir Ahi Evran Universitesi
Collaborators
Assistant Professor Pınar TEKİNSOY KARTIN
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1. Study Identification

Unique Protocol Identification Number
NCT04739488
Brief Title
Breathibg Exercises and Inhaler Trainingfor Chronic Obstructive Pulmonary Disease (COPD) Patients
Acronym
COPD
Official Title
The Effects of Breathing Exercises and Inhaler Training for Chronic Obstructive Pulmonary Disease Patients on the Severity of Dyspnea and Life Quality
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 10, 2017 (Actual)
Primary Completion Date
December 20, 2018 (Actual)
Study Completion Date
December 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran Universitesi
Collaborators
Assistant Professor Pınar TEKİNSOY KARTIN

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The most common symptom of chronic obstructive pulmonary disease (COPD) is shortness of breath and causes a decrease in the patient's quality of life. The best way to relieve shortness of breath is inhaler therapy. However, it is known that patients frequently apply this treatment incorrectly. The aim of this study is to determine the effects of breathing exercises and inhaler training for COPD patients on the severity of dyspnea and life quality. For this, two patient groups with a total of 67 people were included in the study. While one group was trained on inhaler drug use, the other group was taught breathing exercises in addition to the inhaler drug use training. Patients were asked to continue the practices they learned regularly for 4 weeks. At the end of the study, it was observed that shortness of breath decreased and the quality of life increased in both patient groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Breathlessness, Aerocele
Keywords
COPD, Inhaler training, Breathing Exercises, Dyspnea, Quality of Life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
quantitative and qualitative methods
Masking
None (Open Label)
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Breathing exercise and inhaler training
Arm Type
Experimental
Arm Description
This group were given pursed lip breathing exercise and inhaler training.
Arm Title
inhaler training
Arm Type
Experimental
Arm Description
This group were given only inhaler training
Intervention Type
Device
Intervention Name(s)
Inhaler training
Intervention Description
This training was given to both intervention groups. How the patients used their inhaler medication was evaluated. The steps to use the correct inhaler medication were taught sequentially. It was applied with the patient. At the end of the training, brochures prepared by the researchers were given to the patients.
Intervention Type
Behavioral
Intervention Name(s)
Breathing exercises
Intervention Description
This training was given only to the group that received breathing exercise and inhaler training. Pursed lips breathing exercises were taught to the patients. Patients were asked to continue their breathing exercise for 10 minutes before using their inhaler medication. Thus, it was evaluated whether breathing exercises performed before using inhaler drugs provided benefit on drug effectiveness.
Primary Outcome Measure Information:
Title
Patient Information Form
Description
Consisted of 19 questions including sociodemographic and disease features of the patients
Time Frame
It was administered to patients in both groups when they were first included in the study.
Title
Breathing Exercise and Inhaler Application Skill Chart
Description
Consisted of 18 items including the steps of breathing exercises and inhaler utilization to be applied to breathing exercises and inhaler group.
Time Frame
It was administered to patients in breathing ezercises and inhaler training group when they were first enrolled in the study.
Title
Inhaler Application Skill Chart
Description
Consisted of 10 items including only the skill of applying inhaler to be applied to the both group. Correct steps were evaluated as 1 point and wrong steps as 0 points. It was administered to patients when they were first enrolled in the study and when they came for control four weeks later.
Time Frame
It was administered to patients in inhaler training group when they were first enrolled in the study.
Title
COPD assessment test (CAT)
Description
The scale developed by Jones et al. (2009) is used to measure the health status of individuals with COPD.
Time Frame
It was administered to patients in both groups when they were first enrolled in the study.
Title
St. George's respiratory questionnaire (SGRQ)
Description
It is a quality of life questionnaire specific to patients with COPD developed by Jones and Forde (2008).
Time Frame
It was administered to patients in both groups when they were first enrolled in the study.
Title
Modified medical research council (mMRC)
Description
It was developed by the British Medical Research Council in order to provide information about the degree of dyspnea experienced by the patient based on the patient's activity and the patient's perception of the disease. As it is a one-dimensional scale Cronbach's α coefficient could not be calculated.
Time Frame
It was administered to patients in both groups when they were first enrolled in the study.
Secondary Outcome Measure Information:
Title
COPD assessment test (CAT)
Description
The scale developed by Jones et al. (2009) is used to measure the health status of individuals with COPD.
Time Frame
It was administered to patients in both groups when they came for control four weeks later.
Title
Breathing Exercise and Inhaler Application Skill Chart
Description
Consisted of 18 items including the steps of breathing exercises and inhaler utilization to be applied to breathing exercises and inhaler group.
Time Frame
It was administered to patients in breathing ezercises and inhaler training group when they came for control four weeks later.
Title
Inhaler Application Skill Chart
Description
Consisted of 10 items including only the skill of applying inhaler to be applied to the both group. Correct steps were evaluated as 1 point and wrong steps as 0 points. It was administered to patients when they were first enrolled in the study and when they came for control four weeks later.
Time Frame
It was administered to patients in inhaler training group when they came for control four weeks later.
Title
St. George's respiratory questionnaire (SGRQ)
Description
It is a quality of life questionnaire specific to patients with COPD developed by Jones and Forde (2008).
Time Frame
It was administered to patients in both groups when they came for control four weeks later.
Title
Modified medical research council (mMRC)
Description
It was developed by the British Medical Research Council in order to provide information about the degree of dyspnea experienced by the patient based on the patient's activity and the patient's perception of the disease. As it is a one-dimensional scale Cronbach's α coefficient could not be calculated.
Time Frame
It was administered to patients in both groups when they came for control four weeks later.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The individuals over the age of 18, Who had been diagnosed with COPD for at least three months, Using inhalers at least twice a day, Misusing their drug, Had not previously taken breathing exercise training Had not participated in a rehabilitation program Exclusion Criteria: Mental disorders, Communication disabilities, Heart disease that could lead to dyspnea, Unstable angina
Facility Information:
Facility Name
Kırşehir Ahi Evran University Faculty of Health Sciences
City
Kırşehir
State/Province
Centrum
ZIP/Postal Code
40100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36028881
Citation
Ceyhan Y, Tekinsoy Kartin P. The effects of breathing exercises and inhaler training in patients with COPD on the severity of dyspnea and life quality: a randomized controlled trial. Trials. 2022 Aug 26;23(1):707. doi: 10.1186/s13063-022-06603-3.
Results Reference
derived

Learn more about this trial

Breathibg Exercises and Inhaler Trainingfor Chronic Obstructive Pulmonary Disease (COPD) Patients

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