AsthmaNCT04107415
The Effect of Yoga on Respiratory Functions, Symptom Control and Life Quality of Asthma Patients
A study testing yoga in people with Asthma and Yoga, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to find out the effect of yoga applied to asthma patients on the patients' respiratory functions, symptom control and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- What is being tested?
- yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2017to 15 Dec 2018
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- must be between 18 and 55 years old
- must be diagnosed with asthma at least for six months,
- must be living in the city centre,
- must be literate and volunteered to participated in the study, were included in the study
Who cannot join
- be participated in a regular exercise program in the last 6 months,
- be have another respiratory system disease
- be in the exacerbation period,
- have a physical disease or cognitive deficiency and a psychiatric disease diagnosis that could prevent understanding the training given,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Atatürk university nursing faculty
Erzurum, Center, 25240
About this study
Official title: The Effect of Yoga on Respiratory Functions, Symptom Control and Life Quality of Asthma Patients: Randomized Controlled Study
This study was conducted to find out the effect of yoga applied to asthma patients on the patients' respiratory functions, symptom control and quality of life.
Read the detailed description
While there are studies conducted with yoga on different patient groups in Turkey, no studies have been found on asthma patients specifically. For this reason, it was thought that studies are needed which will prove the effect of yoga practices in preventing and controlling symptoms of asthma patients and which will contribute to nursing literature.
- Being tested
- yoga
- Keywords
- Asthma, nursing, patient, yoga
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
yogaOther
A total of 12 yoga sessions, 2 sessions a week for 6 weeks, was applied to the patients in the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Yoga group | Experimental | group doing yoga Receives: Other: yoga |
| No yoga group | No intervention | group not doing yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Quality of Life Questionnaire
Performed to determine the quality of life of asthma patients. Asthma Quality of Life Questionnaire , which addresses both the physical and emotional aspects of the disease has 32 items and four sub-dimensions. These sub-dimensions are activity limitation (items 1, 2, 3, 4, 5, 11, 19, 25, 28, 31, 32), symptoms (items 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 29, 30), emotional functions (items 7, 13, 15, 21, 27) and environmental stimulants (items 9, 17, 23, 26). The scale is a 7-Likert type scale with "1" having the lowest point and "7" the highest point. Weights for the points of the questions are equal. General quality of life is calculated with the averages of all questions, while sub-dimensions are calculated by adding the scores of the related fields. Total score of the scale differs between 32 and 224. Higher total score and sub-dimension score averages mean higher quality of life. diagnosis
Measured: 6 week
Asthma Control Test
The test consists of 5 questions. In this 5-Likert type scale, the scores of the answers are added up and the patient's state is evaluated. The maximum score one can get from this test is 25, while the minimum score is 5. While scoring Asthma Control Test, 25 points is accepted as "full control", 20-24 points is accepted as "good control" and less than 19 points is accepted as "no control". The highest score indicates the best control, while scores less than 19 indicate that the disease is not under control and that modifications should be made in the treatment to reach control.
Measured: 6 week
Respiratory Function tests
Respiratory Function tests is a physiological parameter. Respiratory Function tests are assessed to find out the degree of airway constriction with spirometer and also to find out whether the disease is reversible and to make asthma diagnosis. Forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), peak expiratory flow rate (PEF) and FEV1/FVC measurements were used to evaluate airway constriction
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start15 Dec 2017
- Primary completion15 Apr 2018
- Study completion15 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- Randomization; participants were divided into two groups by using simple random numbers table, and then the first group which was drawn by lot method was named as the experimental group.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, gülcan bahcecioğlu, Ataturk University
- Investigators
- Gülcan Bahçecioğlu Turan, Dr., Principal investigator, Ataturk Üniversty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04107415
- Sponsor's protocol ID
- 2017-10/2
- Status last verified
- Sep 2019
- First submitted
- 21 Sep 2019
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: after the article is published
Publications
Kavak F, Ekinci M. The Effect of Yoga on Functional Recovery Level in Schizophrenic Patients. Arch Psychiatr Nurs. 2016 Dec;30(6):761-767. doi: 10.1016/j.apnu.2016.07.010. Epub 2016 Jul 30.
PubMed 27888972Bahcecioglu Turan G, Tan M. The effect of yoga on respiratory functions, symptom control and life quality of asthma patients: A randomized controlled study. Complement Ther Clin Pract. 2020 Feb;38:101070. doi: 10.1016/j.ctcp.2019.101070. Epub 2019 Oct 28.
PubMed 31679902
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Yoga on Respiratory Functions, Symptom Control and Life Quality of Asthma Patients: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04107415
- Acronym / sponsor ID
- 2017-10/2
- Keywords
- Asthma, nursing, patient, yoga
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 15 Dec 2017 (actual)
- Primary completion
- 15 Apr 2018 (actual)
- Study completion
- 15 Dec 2018 (actual)
- First posted
- 27 Sep 2019 (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.
This study was conducted to find out the effect of yoga applied to asthma patients on the patients' respiratory functions, symptom control and quality of life.
Detailed description
While there are studies conducted with yoga on different patient groups in Turkey, no studies have been found on asthma patients specifically. For this reason, it was thought that studies are needed which will prove the effect of yoga practices in preventing and controlling symptoms of asthma patients and which will contribute to nursing literature.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomization; participants were divided into two groups by using simple random numbers table, and then the first group which was drawn by lot method was named as the experimental group.
| Arm | Type | Receives |
|---|---|---|
| Yoga group | Experimental | Other: yogagroup doing yoga |
| No yoga group | No intervention | –group not doing yoga |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- must be between 18 and 55 years old
- must be diagnosed with asthma at least for six months,
- must be living in the city centre,
- must be literate and volunteered to participated in the study, were included in the study
Key exclusion criteria (4 listed)
- be participated in a regular exercise program in the last 6 months,
- be have another respiratory system disease
- be in the exacerbation period,
- have a physical disease or cognitive deficiency and a psychiatric disease diagnosis that could prevent understanding the training given,
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 |
|---|---|---|
| yogaA total of 12 yoga sessions, 2 sessions a week for 6 weeks, was applied to the patients in the experimental group. | Other | Yoga group |
Primary outcome
Asthma Quality of Life Questionnaire
Time frame: 6 week
Performed to determine the quality of life of asthma patients. Asthma Quality of Life Questionnaire , which addresses both the physical and emotional aspects of the disease has 32 items and four sub-dimensions. These sub-dimensions are activity limitation (items 1, 2, 3, 4, 5, 11, 19, 25, 28, 31, 32), symptoms (items 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 29, 30), emotional functions (items 7, 13, 15, 21, 27) and environmental stimulants (items 9, 17, 23, 26). The scale is a 7-Likert type scale with "1" having the lowest point and "7" the highest point. Weights for the points of the questions are equal. General quality of life is calculated with the averages of all questions, while sub-dimensions are calculated by adding the scores of the related fields. Total score of the scale differs between 32 and 224. Higher total score and sub-dimension score averages mean higher quality of life. diagnosis
Asthma Control Test
Time frame: 6 week
The test consists of 5 questions. In this 5-Likert type scale, the scores of the answers are added up and the patient's state is evaluated. The maximum score one can get from this test is 25, while the minimum score is 5. While scoring Asthma Control Test, 25 points is accepted as "full control", 20-24 points is accepted as "good control" and less than 19 points is accepted as "no control". The highest score indicates the best control, while scores less than 19 indicate that the disease is not under control and that modifications should be made in the treatment to reach control.
Respiratory Function tests
Time frame: 6 week
Respiratory Function tests is a physiological parameter. Respiratory Function tests are assessed to find out the degree of airway constriction with spirometer and also to find out whether the disease is reversible and to make asthma diagnosis. Forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), peak expiratory flow rate (PEF) and FEV1/FVC measurements were used to evaluate airway constriction
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 27 Sep 2019.
- Background: PubMed 27888972Kavak F, Ekinci M. The Effect of Yoga on Functional Recovery Level in Schizophrenic Patients. Arch Psychiatr Nurs. 2016 Dec;30(6):761-767. doi: 10.1016/j.apnu.2016.07.010. Epub 2016 Jul 30.
- Derived from this study: PubMed 31679902Bahcecioglu Turan G, Tan M. The effect of yoga on respiratory functions, symptom control and life quality of asthma patients: A randomized controlled study. Complement Ther Clin Pract. 2020 Feb;38:101070. doi: 10.1016/j.ctcp.2019.101070. Epub 2019 Oct 28.
- Individual participant dataSharing planned: No. after the article is published
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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.
Gülcan Bahçecioğlu Turan, Dr. principal investigator
Ataturk Üniversty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing yoga in people with Asthma and Yoga, run by Ataturk 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 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 27 Sep 2019. 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?
Asthma Quality of Life Questionnaire (time frame: 6 week). 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?
On the ClinicalTrials.gov record for NCT04107415, which also lists 2 linked publications.
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 27 Sep 2019.