- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05684926
COVID-19 Pandemic Asthma Child Telerehabilitation Yoga
Investigation of the Effect of Yoga Training With Telerehabilitation on Asthma Control, Functional Capacity, Physical Fitness, Physical Activity and Quality of Life in Children With Asthma During the COVID-19 Pandemic Process
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Altındağ
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Ankara, Altındağ, Turkey, 06000
- Hacettepe University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Hacettepe University Faculty of Medicine, Department of Pediatrics, Allergy and Asthma Unit patients were referred for Cardiopulmonary Rehabilitation,
- Those who have been diagnosed with asthma,
- Not in an asthma attack but clinically stable,
- Between the ages of 6-11,
- Giving consent on a voluntary basis,
- cooperative,
- Ability to use a smart phone or computer,
Exclusion Criteria:
- Individuals with internet connection will be included in the research. Individuals with asthma were included in the study.
- In an asthma attack and clinically unstable,
- Having serious diseases such as cancers, heart failure and acute respiratory infections,
- Having chronic lung disease other than asthma,
- Severe neuromuscular and musculoskeletal problems,
- Uncooperative to make surveys and scales,
- Admitted or hospitalized due to an asthma attack in the last 3 months for safety reasons,
- Having neuropsychiatric diseases,
- Individuals who do not volunteer to participate in the study 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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Experimental Group
The intervention group is a group of asthmatic children aged 6-11 years, determined by randomization.
Yoga asana includes pranayama and concentration.
It will be held 3 days a week for 12 weeks.
|
Yoga consists of bodily postures or poses called asanas, breathing practices called pranayama, and meditation sections that provide focus.
Children's yoga aims to teach pre-school (3-6 years) and school (7-12 years) children to breathe correctly, to practice yoga postures using their imaginations, to preserve their existing body flexibility and to teach correct posture.
It consists of compositions such as postures, breathing exercises, imitations of living things in nature, memory games.
They also relax with the pranayama breathing exercises done during the session.
It aims to develop children's creativity through relaxation exercises, moving poses and stories told.
Children's yoga also serves an artistic aspect with activities such as listening to music, singing, rhythm games, and drawing.
Other Names:
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No Intervention: Control Group
The control group is a group of asthmatic children aged 6-11 years, determined by randomization method.
He will be put on the waiting list and after the second evaluation, yoga exercises will be done for 8 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
respiratory function (pulmoner function test)
Time Frame: one day
|
It is evaluated with the Pulmonary Function Test.
After a deep, full inspiration, a forced expiratory maneuver is performed.
Used with disposable antiviral filter.
The patient's height and body weight are measured and recorded with age.
It is done 3 times, there should be no more than 10% difference between the values.
The highest value is accepted.
|
one day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
asthma control
Time Frame: one day
|
The Child Asthma Control Test (C-AKT) has a total of 7 items and covers the last 4 weeks.
The first of the two sections is filled in by the child and consists of four questions about perception of asthma control, restriction of activities, coughing, and night awakenings.
The second part is filled in by the parent or caregiver and consists of three questions (daytime complaints, daytime wheezing and night waking).
The overall score ranges from 0 (poorest asthma control) to 27 (optimal asthma control).
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one day
|
|
functional capacity
Time Frame: one day
|
six munite walk test It will be measured with the 6 Minute Walk Test.
You can walk for 6 minutes at a fast pace without running in the 30 m long corridor.
The distance walked is recorded.
Vital values are recorded before and after.
|
one day
|
|
physical fitness
Time Frame: one day
|
FITNESSGRAM test batary The fitnessgram will be evaluated with the test battery.
Valid from 5 years old.
(a) Sit and lie down with back support (b) Trunk Extension (c) Trunk Lateral Flexion, Curl (d) Do push-ups.
(e) For progressive aerobic cardiovascular endurance running (PACER), the time set for reaching 20 meters is 9 seconds, reduced by half a second per minute.
If the rhythm cannot be kept up or the boundary line is not reached before the beep twice, the test is stopped and the number of laps is recorded.
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one day
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physical activity
Time Frame: one day
|
physical activity questionnaire child It examines the physical activity of children in the last seven days and the frequency of activities.
It consists of 10 questions and a 5-point Likert structure.
The first question questions activity and frequency.
The 9th question questions the activity frequency on the days of the week.
The remaining 8 questions evaluate sports, dance and play activity during the day or at certain time intervals throughout the week.
Each question has a score of 1-5.
The minimum score that can be obtained from the FAS is 9 and the maximum score is 45.
The 10th question of the FAS questions any reason that prevents physical activity and is not scored.
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one day
|
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pediatric asthma quality of life questionnaire
Time Frame: one day
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pediatric asthma quality of life questionnaire It was developed to measure the physical, mental and social disorders of children with asthma (7-17 years old).
The scale, which questions the asthma experience in the last week, consists of 3 sub-units, namely 'symptoms', 'activity limitation' and 'emotional function', and 23 questions.
Each question is in 7-point Likert type, showing 1- the worst and 7- the best situation.
The score to be taken from the scale is between 23-167 and the total score is divided by the number of questions and scoring is done.
A high score indicates good quality of life.
|
one day
|
|
pediatric reach test
Time Frame: one day
|
Evaluates the dynamic component of balance.
It is performed by recording the distance in cm with a tape measure that they can reach forward and then to the right and left, respectively, without raising their heels from the ground in standing upright positions.
|
one day
|
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periferic muscle test
Time Frame: one day
|
Peripheral Muscle Strength Hand Grip Test: Jamar hand dynamometer is used. The person sits in an upright position with the knees at 90°, the wrists are in neutral, the elbow is 90° and the dynamometer is gripped with all his strength, and the measurements are repeated 3 times on the right and left, with 10 seconds intervals. Quadriceps Muscle Strength: A hand-held dynamometer (Lafayette Manual Muscle Testing System; Lafayette Instrument Company, Lafayette, Indiana, USA) is used to measure lower extremity muscle strength. People sit with their knees and hips 90º. It is requested to maintain knee extension. |
one day
|
Collaborators and Investigators
Sponsor
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- COVID-19
- Asthma
Other Study ID Numbers
- KA22030
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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