- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04744220
Evaluation of the Effect of Yoga Training on Functional Capacity and Quality of Life in Patients With Bronchiectasis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Istanbul, Turkey (Türkiye), 34000
- Istanbul Medipol University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosed with bronchiectasis
- Age 30-55
- Not having a known systemic, orthopedic or neurological disease
Exclusion Criteria:
- Severe heart failure
- People who had an acute exacerbation up to three weeks ago will not be included in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Yoga Training Group
Training: Before the yoga program, the patients will be informed about the bronchiectasis disease and its symptoms, as well as all the parameters used in the evaluation, tests and the content of the yoga session. During the program, the perceived fatigue intensity of the patients will be questioned with the Modified Borg Scale. Yoga Session 1-8 weeks and duration
|
Training: Before the yoga program, the patients will be informed about the bronchiectasis disease and its symptoms, as well as all the parameters used in the evaluation, tests and the content of the yoga session.
The patients will start with breathing exercises, then relaxation exercises, warm-up exercises, asanas (posture exercises) and finally the yoga training program will be completed with deep relaxation technique.
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|
No Intervention: Control group
Training: The exercise program will include respiration exercises that they can do at home. Before the exercise program, the patients will be informed about the bronchiectasis disease and its symptoms, as well as all the parameters and tests used in the evaluation. Respiratory control, breathing exercises, relaxation techniques and the reasons, importance and effects of exercise training in the treatment program will be explained. Breathing Exercises (10 min) Pursed-lip breathing training, Chest breathing exercise (10 repetitions), Diaphragmatic breathing exercise (10 repetitions), Bilateral basal expansion breathing exercises (10 repetitions) |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Follow-up Form
Time Frame: Baseline
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The demographic characteristics, physical characteristics such as age, height and body weight of the individuals included in the study and their education status will be recorded.
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dyspnea Assessment
Time Frame: Before and after treatment (8 week)
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Dyspnea will be assessed by the modified Medical Research Council (MMRC) dyspnea scale. Individuals will be asked to choose the statement that best describes their dyspnea level. Scoring in MMRC varies between 0-4 points. "0 points" means that there is no dyspnea; "4 points" indicates a perception of dyspnea during basic daily life activities such as dressing. |
Before and after treatment (8 week)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Respiratory Function Test
Time Frame: Before and after treatment( 8 week )
|
A spirometer will be used to evaluate the lung function of individuals.
It will be expressed as a percentage of the expected values by age, height, body weight and gender.
|
Before and after treatment( 8 week )
|
|
Quality of Life Assessment
Time Frame: Before and after treatment (8 week)
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Quality of life, St. George's Respiratory Questionnaire (SGRQ). SGRQ is a health-related quality of life questionnaire that questions a total of 50 items under 3 main components: symptoms (8 items), activity (16 items) and effects of disease (26 items). The symptoms component includes the frequency and duration of symptoms such as cough, sputum, shortness of breath, wheezing. The activity component relates to physical activities that are restricted due to shortness of breath. It includes factors such as the effects component of the disease, the drugs used and its side effects, the individual's expectations for health and the discomfort they face in daily life. The total score is between 0-100. The higher the score, the lower the quality of life |
Before and after treatment (8 week)
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|
Evaluation of Functional Capacity
Time Frame: Before and after treatment (8 week)
|
Individuals' functional capacity will be evaluated with the six-minute walking test (6MWT). During the 6MWT, individuals are asked to walk in a straight corridor of 30 meters as fast as possible, at their own walking pace in standard directions. At the end of the test, the walking distance is recorded in meters. |
Before and after treatment (8 week)
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Assessment of Sleep Quality
Time Frame: Before and after treatment (8 week)
|
Pittsburgh Sleep Quality Index (PSQI) will be used to evaluate the sleep quality of the individuals participating in our study before and after the 8-week study period. PSQI is a test that plays a role in determining sleep quality and sleep-related disorders in the last month. It is a scale consisting of 19 self-report items, a total of 24 questions with a score range of 0-21, and the remaining five questions must be answered by a roommate or a spouse. It is a test that evaluates a wide variety of areas related to sleep quality, including components, sleep time, delays in falling asleep, the frequency and severity of sleep-related problems, and the impact of poor sleep on an individual's work. |
Before and after treatment (8 week)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Salih Tan, Istanbul Medipol University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10840098-604.01.01-E.19408
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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