Quality of LifeNCT06706297
Effect of Breathıng Exercıse Applıed to Indıvıduals Wıth Copd on Respıratory Functıon, Dyspnea and Qualıty of Lıfe
A study testing pranayama breathing exercise in people with Quality of Life, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
Purpose of the research This research was designed to determine the effect of breathing exercise applied to individuals diagnosed with COPD on respiratory function, dyspnea and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life
- What is being tested?
- pranayama breathing exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 25 Jul 2024
- 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
- Diagnosed with COPD for at least 1 year, confirmed by pulmonary function test
- Those who voluntarily accepted to participate in the research
- Those aged 18 and over,
- Individuals who have access to the hospital
Who cannot join
- In COPD exacerbation period,
- Having a neurological or psychiatric diagnosis,
- Those with obesity,
- Those with physical disabilities (vision, hearing, walking, etc.),
- Those who are pregnant,
- Illiterate
- Diagnosed with another disease that significantly affects the respiratory system (scoliosis, lung cancer, abdominal tumor, etc.).
- Patients who have previously participated in an exercise program will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Purpose of the research This research was designed to determine the effect of breathing exercise applied to individuals diagnosed with COPD on respiratory function, dyspnea and quality of life.
Hypotheses of the Research H0a: Breathing exercise applied to individuals diagnosed with COPD has no effect on the respiratory function test FEV1/FVC.
Read more
H1a: Breathing exercise applied to individuals diagnosed with COPD has an effect on the respiratory function test FEV1/FVC.
H0b: Breathing exercise applied to individuals diagnosed with COPD has no effect on dyspnea.
H1b: Breathing exercise applied to individuals diagnosed with COPD has an effect on dyspnea.
H0c: Breathing exercise applied to individuals diagnosed with COPD has no effect on quality of life.
H1c: Breathing exercise applied to individuals diagnosed with COPD has an effect on the quality of life.
- Conditions
- Quality of Life
- Being tested
- pranayama breathing exercise
- Keywords
- Dyspnea, COPD, Breathing Exercise, Pranayama, Respiratory Function, Quality of Life.
- Medical subject headings
- Dyspnea, Pulmonary Disease, Chronic Obstructive, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pranayama breathing exerciseOther
Normal breathing, focusing on breathing, Alternative Nose Breathing, Cooling Breath, Bee Buzzing Sound, A breathing exercise of 20 minutes in total, consisting of 5 stages: normal breathing and focusing on breathing.
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | Control group patients will not undergo any exercise and the normal clinical protocol will not be interfered with. |
| breathing exercise group | Experimental | The researcher will make the application group patients perform a 30-minute pranayama exercise twice a week for 6 weeks. Receives: Other: pranayama breathing exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
pulmonary function test
The effect of breathing exercise applied to individuals with COPD on respiratory function test FEV1/FVC
Measured: 6 weeks
Dyspnea severity
The effect of breathing exercise applied to individuals with COPD on dyspnea
Measured: 6 weeks
Saint George's Solunum Anket
The effect of breathing exercise applied to individuals with COPD on quality of life
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start1 Jan 2023
- Primary completion1 Jul 2024
- Study completion25 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe 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
- This research was planned as a prospective, randomized controlled, experimental type study with pretest-posttest measurements to determine the effect of breathing exercise on dyspnea, respiratory function and quality of life in patients with COPD.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aybike Kose, Ondokuz Mayıs University
- Investigators
- Aybike KÖSE, 1, Study chair, Ondokuz Mayıs UniversityAfitap ÖZDELİKARA, 2, Study director, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06706297
- Sponsor's protocol ID
- OMU-SBF-HEM-01
- Status last verified
- Nov 2024
- First submitted
- 21 Nov 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Breathıng Exercıse Applıed to Indıvıduals Wıth Copd on Respıratory Functıon, Dyspnea and Qualıty of Lıfe
- ClinicalTrials.gov ID
- NCT06706297
- Acronym / sponsor ID
- OMU-SBF-HEM-01
- Conditions
- Quality of Life
- Keywords
- Dyspnea, COPD, Breathing Exercise, Pranayama, Respiratory Function, Quality of Life.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 25 Jul 2024 (actual)
- First posted
- 26 Nov 2024 (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.
Purpose of the research This research was designed to determine the effect of breathing exercise applied to individuals diagnosed with COPD on respiratory function, dyspnea and quality of life.
Hypotheses of the Research H0a: Breathing exercise applied to individuals diagnosed with COPD has no effect on the respiratory function test FEV1/FVC.
H1a: Breathing exercise applied to individuals diagnosed with COPD has an effect on the respiratory function test FEV1/FVC.
H0b: Breathing exercise applied to individuals diagnosed with COPD has no effect on dyspnea.
H1b: Breathing exercise applied to individuals diagnosed with COPD has an effect on dyspnea.
H0c: Breathing exercise applied to individuals diagnosed with COPD has no effect on quality of life.
H1c: Breathing exercise applied to individuals diagnosed with COPD has an effect on the quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This research was planned as a prospective, randomized controlled, experimental type study with pretest-posttest measurements to determine the effect of breathing exercise on dyspnea, respiratory function and quality of life in patients with COPD.
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –Control group patients will not undergo any exercise and the normal clinical protocol will not be interfered with. |
| breathing exercise group | Experimental | Other: pranayama breathing exerciseThe researcher will make the application group patients perform a 30-minute pranayama exercise twice a week for 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with COPD for at least 1 year, confirmed by pulmonary function test
- Those who voluntarily accepted to participate in the research
- Those aged 18 and over,
- Individuals who have access to the hospital
Key exclusion criteria (8 listed)
- In COPD exacerbation period,
- Having a neurological or psychiatric diagnosis,
- Those with obesity,
- Those with physical disabilities (vision, hearing, walking, etc.),
- Those who are pregnant,
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 |
|---|---|---|
| pranayama breathing exerciseNormal breathing, focusing on breathing, Alternative Nose Breathing, Cooling Breath, Bee Buzzing Sound, A breathing exercise of 20 minutes in total, consisting of 5 stages: normal breathing and focusing on breathing. | Other | breathing exercise group |
Primary outcome
pulmonary function test
Time frame: 6 weeks
The effect of breathing exercise applied to individuals with COPD on respiratory function test FEV1/FVC
Dyspnea severity
Time frame: 6 weeks
The effect of breathing exercise applied to individuals with COPD on dyspnea
Saint George's Solunum Anket
Time frame: 6 weeks
The effect of breathing exercise applied to individuals with COPD on quality of life
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 26 Nov 2024.
- 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.
Aybike KÖSE, 1 study chair
Ondokuz Mayıs University
Afitap ÖZDELİKARA, 2 study director
Ondokuz Mayıs University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pranayama breathing exercise in people with Quality of Life, run by Ondokuz Mayıs University 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 4 inclusion and 8 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 26 Nov 2024. 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?
pulmonary function test (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Nov 2024.