Chronic Respiratory DiseaseNCT04623762
Yoga On Dyspnea, Sleep And Fatıgue In Chronıc Respıratory Dıseases
A study testing Yoga in people with Chronic Respiratory Disease, run by Ataturk University at 2 sites in Turkey (Türkiye).
Trial summary
Although there are a limited number of studies in the literature investigating the effect of yoga on dyspnea, quality of life and respiratory functions of chronic respiratory patients There is no study examining the effect of yoga on sleep and fatigue of chronic respiratory patients. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Respiratory Disease
- What is being tested?
- Yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 May 2020to 28 Jul 2020
- 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
- Between the ages of 18-55 and diagnosed with asthma and COPD for at least six months,
- Do not have any disease that causes insomnia and do not use sleeping pills
- Has the ability to use the internet actively, download the ZOOM program to the phone or computer and participate in the application.
- Have not participated in a similar regular exercise program in the last 6 months,
- Do not have any respiratory system disease other than asthma and COPDY,
- Not in exacerbation period,
- Do not have a physical illness or cognitive deficiency and a psychiatric disease that prevents understanding of the education given,
- Patients who were literate and volunteered to participate in the study were included in the study.
Who cannot join
- In the period of exacerbation Have participated in a similar regular exercise program in the last 6 months, Those who cannot download the ZOOM program and participate in the application
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Fırat university
Erzurum, Center, 25240
Sabahattin Zaim University
Istanbul, Center, 25240
About this study
Official title: Effect Of Yoga On Dyspnea, Sleep And Fatıgue In Chronıc Respıratory Dıseases
Although there are a limited number of studies in the literature investigating the effect of yoga on dyspnea, quality of life and respiratory functions of chronic respiratory patients There is no study examining the effect of yoga on sleep and fatigue of chronic respiratory patients. Therefore, this study was conducted to determine the effect of yoga on dyspnea, sleep, and fatigue applied to chronic respiratory patients.
Read the detailed description
Chronic respiratory diseases (CSFD) are chronic diseases of the airways and other structures of the lung. Two of the most common of these diseases are asthma and chronic obstructive pulmonary disease. Asthma and chronic obstructive pulmonary disease (COPD); mortality, morbidity and prevalence of chronic respiratory diseases are increasingly increasing across countries. COPD; It has been defined as a common, preventable and treatable disease characterized by permanent airflow restriction, which is associated with the increased chronic inflammatory response of the airways and lungs to harmful gases and particles Every year, 3 million people die of COPD in the world and this rate constitutes 6% of all deaths If it is asthma; It is defined as a heterogeneous disease characterized by chronic airway inflammation associated with airway hyperresponsiveness to direct or indirect stimuli. Asthma is seen at a rate of 1-18% in the whole world population
- Conditions
- Chronic Respiratory Disease
- Being tested
- Yoga
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaOther
yoga application
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | yoga was not done |
| Experimental group | Experimental | yoga was done Receives: Other: Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic Obstructive Pulmonary Disease and Asthma Fatigue Scale
Revicki et al. (2010) to determine the effect of COPD and asthma on fatigue. Cronbach's alpha value of the scale was found to be 0.95. The scale, which consists of 12 items, is a five-point Likert type, and the minimum total score that can be obtained from the scale is 12 and the maximum total score is 60. The higher the score obtained from the scale indicates that the fatigue level of the person is high. Turkey on the scale of the Turkish validity and reliability study of Arslan and by Öztunç (2013) was determined to be conducted and Cronbach's alpha values for the reliability coefficient of 0.92.
Measured: Change from Baseline Fatigue at 2 months
Secondary outcomes (1)
Asthma and COPD Sleep Scale (CASIS)
It was developed by Pokrzywinski et al. (2009) to reveal the effect of asthma and COPD disease on sleep. The Cronbach Alpha Coefficient of the scale was found to be 0.90. The Turkish validity and reliability study of the scale was conducted by Ayhan and Kıyak (2011) and the cronbach alpha coefficient was determined as 0.87. The items of the questions in the scale consisting of 7 questions in total are likert in the form of never, rarely, sometimes, often, and very often.
Measured: Change from Baseline Sleep at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start1 May 2020
- Primary completion15 May 2020
- Study completion28 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Respiratory DiseaseStudies 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 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, Principal investigator, Fırat Universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04623762
- Sponsor's protocol ID
- 2020/4
- Status last verified
- Nov 2020
- First submitted
- 29 Oct 2020
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Yoga On Dyspnea, Sleep And Fatıgue In Chronıc Respıratory Dıseases
- ClinicalTrials.gov ID
- NCT04623762
- Acronym / sponsor ID
- 2020/4
- Conditions
- Chronic Respiratory Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 28 Jul 2020 (actual)
- First posted
- 10 Nov 2020 (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.
Although there are a limited number of studies in the literature investigating the effect of yoga on dyspnea, quality of life and respiratory functions of chronic respiratory patients There is no study examining the effect of yoga on sleep and fatigue of chronic respiratory patients. Therefore, this study was conducted to determine the effect of yoga on dyspnea, sleep, and fatigue applied to chronic respiratory patients.
Detailed description
Chronic respiratory diseases (CSFD) are chronic diseases of the airways and other structures of the lung. Two of the most common of these diseases are asthma and chronic obstructive pulmonary disease. Asthma and chronic obstructive pulmonary disease (COPD); mortality, morbidity and prevalence of chronic respiratory diseases are increasingly increasing across countries. COPD; It has been defined as a common, preventable and treatable disease characterized by permanent airflow restriction, which is associated with the increased chronic inflammatory response of the airways and lungs to harmful gases and particles Every year, 3 million people die of COPD in the world and this rate constitutes 6% of all deaths If it is asthma; It is defined as a heterogeneous disease characterized by chronic airway inflammation associated with airway hyperresponsiveness to direct or indirect stimuli. Asthma is seen at a rate of 1-18% in the whole world population
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –yoga was not done |
| Experimental group | Experimental | Other: Yogayoga was done |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Between the ages of 18-55 and diagnosed with asthma and COPD for at least six months,
- Have not participated in a similar regular exercise program in the last 6 months,
- Do not have any respiratory system disease other than asthma and COPDY,
- Not in exacerbation period,
- Do not have a physical illness or cognitive deficiency and a psychiatric disease that prevents understanding of the education given,
Key exclusion criteria (1 listed)
- In the period of exacerbation Have participated in a similar regular exercise program in the last 6 months, Those who cannot download the ZOOM program and participate in the application
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 |
|---|---|---|
| Yogayoga application | Other | Experimental group |
Primary outcome
Chronic Obstructive Pulmonary Disease and Asthma Fatigue Scale
Time frame: Change from Baseline Fatigue at 2 months
Revicki et al. (2010) to determine the effect of COPD and asthma on fatigue. Cronbach's alpha value of the scale was found to be 0.95. The scale, which consists of 12 items, is a five-point Likert type, and the minimum total score that can be obtained from the scale is 12 and the maximum total score is 60. The higher the score obtained from the scale indicates that the fatigue level of the person is high. Turkey on the scale of the Turkish validity and reliability study of Arslan and by Öztunç (2013) was determined to be conducted and Cronbach's alpha values for the reliability coefficient of 0.92.
1 secondary outcome
Asthma and COPD Sleep Scale (CASIS)
Time frame: Change from Baseline Sleep at 2 months
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 10 Nov 2020.
- 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.
Gülcan Bahçecioğlu Turan principal investigator
Fırat Universty
2 sites 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 Chronic Respiratory Disease, run by Ataturk University at 2 sites 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 8 inclusion and 1 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 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Chronic Obstructive Pulmonary Disease and Asthma Fatigue Scale (time frame: Change from Baseline Fatigue at 2 months). 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 10 Nov 2020.