NCT04739488

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2019

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 5, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
Last Updated

February 4, 2021

Status Verified

February 1, 2021

Enrollment Period

1.3 years

First QC Date

January 5, 2021

Last Update Submit

February 3, 2021

Conditions

Keywords

COPDInhaler trainingBreathing ExercisesDyspneaQuality of Life

Outcome Measures

Primary Outcomes (6)

  • Patient Information Form

    Consisted of 19 questions including sociodemographic and disease features of the patients

    It was administered to patients in both groups when they were first included in the study.

  • 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.

    It was administered to patients in breathing ezercises and inhaler training group when they were first enrolled in the study.

  • 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.

    It was administered to patients in inhaler training group when they were first enrolled in the study.

  • COPD assessment test (CAT)

    The scale developed by Jones et al. (2009) is used to measure the health status of individuals with COPD.

    It was administered to patients in both groups when they were first enrolled in the study.

  • St. George's respiratory questionnaire (SGRQ)

    It is a quality of life questionnaire specific to patients with COPD developed by Jones and Forde (2008).

    It was administered to patients in both groups when they were first enrolled in the study.

  • 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.

    It was administered to patients in both groups when they were first enrolled in the study.

Secondary Outcomes (5)

  • COPD assessment test (CAT)

    It was administered to patients in both groups when they came for control four weeks later.

  • Breathing Exercise and Inhaler Application Skill Chart

    It was administered to patients in breathing ezercises and inhaler training group when they came for control four weeks later.

  • Inhaler Application Skill Chart

    It was administered to patients in inhaler training group when they came for control four weeks later.

  • St. George's respiratory questionnaire (SGRQ)

    It was administered to patients in both groups when they came for control four weeks later.

  • Modified medical research council (mMRC)

    It was administered to patients in both groups when they came for control four weeks later.

Study Arms (2)

Breathing exercise and inhaler training

EXPERIMENTAL

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

Device: Inhaler trainingBehavioral: Breathing exercises

inhaler training

EXPERIMENTAL

This group were given only inhaler training

Device: Inhaler training

Interventions

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.

Breathing exercise and inhaler traininginhaler training

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.

Breathing exercise and inhaler training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırşehir Ahi Evran University Faculty of Health Sciences

Kırşehir, Centrum, 40100, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveDyspnea

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersSigns and Symptoms, RespiratorySigns and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: quantitative and qualitative methods
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Yasemin CEYHAN

Study Record Dates

First Submitted

January 5, 2021

First Posted

February 4, 2021

Study Start

September 10, 2017

Primary Completion

December 20, 2018

Study Completion

December 25, 2019

Last Updated

February 4, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations