COPDCOPDNCT04739488
Breathibg Exercises and Inhaler Trainingfor Chronic Obstructive Pulmonary Disease (COPD) Patients
A study testing Inhaler training and Breathing exercises in people with COPD and Breathlessness, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, Breathlessness, Aerocele
- What is being tested?
- Inhaler training and Breathing exercises
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Sep 2017to 25 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Mental disorders,
- Communication disabilities,
- Heart disease that could lead to dyspnea,
- Unstable angina
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kırşehir Ahi Evran University Faculty of Health Sciences
Kırşehir, Centrum, 40100
About this study
Official title: The Effects of Breathing Exercises and Inhaler Training for Chronic Obstructive Pulmonary Disease Patients on the Severity of Dyspnea and Life Quality
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.
- Conditions
- COPD, Breathlessness, Aerocele
- Being tested
- Inhaler training, Breathing exercises
- Keywords
- COPD, Inhaler training, Breathing Exercises, Dyspnea, Quality of Life
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaler trainingDevice
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 exercisesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Breathing exercise and inhaler training | Experimental | This group were given pursed lip breathing exercise and inhaler training. Receives: Device: Inhaler training; Behavioral: Breathing exercises |
| inhaler training | Experimental | This group were given only inhaler training Receives: Device: Inhaler training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Information Form
Consisted of 19 questions including sociodemographic and disease features of the patients
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: It was administered to patients in both groups when they were first enrolled in the study.
Secondary outcomes (5)
COPD assessment test (CAT)
The scale developed by Jones et al. (2009) is used to measure the health status of individuals with COPD.
Measured: It was administered to patients in both groups when they came for control four weeks later.
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.
Measured: It was administered to patients in breathing ezercises and inhaler training group when they came for control four weeks later.
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.
Measured: It was administered to patients in inhaler training group 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).
Measured: It was administered to patients in both groups when they came for control four weeks later.
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.
Measured: It was administered to patients in both groups when they came for control four weeks later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start10 Sep 2017
- Primary completion20 Dec 2018
- Study completion25 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- quantitative and qualitative methods
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Collaborators
- Assistant Professor Pınar TEKİNSOY KARTIN
- Responsible party
- Principal investigator, Yasemin CEYHAN, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04739488
- Sponsor's protocol ID
- Yasemin Ceyhan
- Acronym
- COPD
- Status last verified
- Feb 2021
- First submitted
- 5 Jan 2021
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36028881
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Breathing Exercises and Inhaler Training for Chronic Obstructive Pulmonary Disease Patients on the Severity of Dyspnea and Life Quality
- ClinicalTrials.gov ID
- NCT04739488
- Acronym / sponsor ID
- COPD / Yasemin Ceyhan
- Conditions
- COPD, Breathlessness, Aerocele
- Keywords
- COPD, Inhaler training, Breathing Exercises, Dyspnea, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Collaborators
- Assistant Professor Pınar TEKİNSOY KARTIN
- Study start
- 10 Sep 2017 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 25 Dec 2019 (actual)
- First posted
- 4 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- quantitative and qualitative methods
| Arm | Type | Receives |
|---|---|---|
| Breathing exercise and inhaler training | Experimental | Device: Inhaler training, Behavioral: Breathing exercisesThis group were given pursed lip breathing exercise and inhaler training. |
| inhaler training | Experimental | Device: Inhaler trainingThis group were given only inhaler training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Mental disorders,
- Communication disabilities,
- Heart disease that could lead to dyspnea,
- Unstable angina
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhaler trainingThis 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. | Device | Breathing exercise and inhaler training, inhaler training |
| Breathing exercisesThis 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. | Behavioural | Breathing exercise and inhaler training |
Primary outcome
Patient Information Form
Time frame: It was administered to patients in both groups when they were first included in the study.
Consisted of 19 questions including sociodemographic and disease features of the patients
Breathing Exercise and Inhaler Application Skill Chart
Time frame: It was administered to patients in breathing ezercises and inhaler training group when they were first enrolled in the study.
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
Time frame: It was administered to patients in inhaler training group when they were first enrolled in the study.
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)
Time frame: It was administered to patients in both groups when they were first enrolled in the study.
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)
Time frame: It was administered to patients in both groups when they were first enrolled in the study.
It is a quality of life questionnaire specific to patients with COPD developed by Jones and Forde (2008).
Modified medical research council (mMRC)
Time frame: It was administered to patients in both groups when they were first enrolled in the study.
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.
5 secondary outcomes
COPD assessment test (CAT)
Time frame: It was administered to patients in both groups when they came for control four weeks later.
Breathing Exercise and Inhaler Application Skill Chart
Time frame: It was administered to patients in breathing ezercises and inhaler training group when they came for control four weeks later.
Inhaler Application Skill Chart
Time frame: It was administered to patients in inhaler training group when they came for control four weeks later.
St. George's respiratory questionnaire (SGRQ)
Time frame: It was administered to patients in both groups when they came for control four weeks later.
Modified medical research council (mMRC)
Time frame: It was administered to patients in both groups when they came for control four weeks later.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Derived from this study: PubMed 36028881Ceyhan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inhaler training and Breathing exercises in people with COPD and Breathlessness, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Information Form (time frame: It was administered to patients in both groups when they were first included in the study.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04739488, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.