Back to resultsYoga On Dyspnea, Sleep And Fatıgue In Chronıc Respıratory Dıseases
Primary Purpose
Chronic Respiratory Disease
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Yoga
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Respiratory Disease
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
- 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
Sites / Locations
- Fırat university
- Sabahattin Zaim University
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Experimental group
Arm Description
yoga was not done
yoga was done
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04623762
Brief Title
Yoga On Dyspnea, Sleep And Fatıgue In Chronıc Respıratory Dıseases
Official Title
Effect Of Yoga On Dyspnea, Sleep And Fatıgue In Chronıc Respıratory Dıseases
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
May 15, 2020 (Actual)
Study Completion Date
July 28, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Respiratory Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
yoga was not done
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
yoga was done
Intervention Type
Other
Intervention Name(s)
Yoga
Intervention Description
yoga application
Primary Outcome Measure Information:
Title
Chronic Obstructive Pulmonary Disease and Asthma Fatigue Scale
Description
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.
Time Frame
Change from Baseline Fatigue at 2 months
Secondary Outcome Measure Information:
Title
Asthma and COPD Sleep Scale (CASIS)
Description
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.
Time Frame
Change from Baseline Sleep at 2 months
Other Pre-specified Outcome Measures:
Title
Medical Research Board Dyspnea Scale (MRC):
Description
t is a five-item scale developed by the British Medical Research Board for the evaluation of dyspnea. While applying the Medical Research Council Dyspnea Scale, patients are asked to indicate the activity level that causes dyspnea. The patient chooses the most appropriate level that defines the respiratory distress by reading the options on the scale. The options are graded from 0 to 4; 0 points, no dyspnea; 1 point of mild dyspnea (respiratory distress when moving fast on a flat surface and climbing slightly uphill); 2 points of moderate dyspnea (walk slower than peers when walking on a flat surface, pausing to breathe); 3 points are scored as severe dyspnea (stopping to breathe after walking for 100 meters or a few minutes) and 4 points as very severe dyspnea (breathlessness while wearing clothes, taking off or going to the toilet while doing daily work at home).
Time Frame
Change from Baseline MRC at 2 months
Title
Pulmonary Functions Monitoring Form
Description
Pulmonary function tests are evaluated with the spirometer to determine the degree of airway limitation and whether it is reversible and to diagnose asthma. Forced vital capacity (FVC), forced expiratory volume in one second (FEV1), highest expiratory flow rate (PEF) and FEV1 / FVC measurements were evaluated to evaluate its restriction.
Time Frame
Change from Baseline Pulmonary Functions at 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gülcan Bahçecioğlu Turan
Organizational Affiliation
Fırat Universty
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fırat university
City
Erzurum
State/Province
Center
ZIP/Postal Code
25240
Country
Turkey
Facility Name
Sabahattin Zaim University
City
İstanbul
State/Province
Center
ZIP/Postal Code
25240
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Yoga On Dyspnea, Sleep And Fatıgue In Chronıc Respıratory Dıseases
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