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COVID-19 Pandemic Asthma Child Telerehabilitation Yoga

Primary Purpose

Asthma in Children, Telerehabilitation, Yoga

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Telerehabilitation yoga
Sponsored by
Bartın Unıversity
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma in Children focused on measuring Asthma, Rehabilitation, Physical Fitness, Physical activity

Eligibility Criteria

6 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hacettepe UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

respiratory function (pulmoner function test)
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.

Secondary Outcome Measures

asthma control
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).
functional capacity
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.
physical fitness
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.
physical activity
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.
pediatric asthma quality of life questionnaire
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.
pediatric reach test
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.
periferic muscle test
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.

Full Information

First Posted
January 12, 2023
Last Updated
January 12, 2023
Sponsor
Bartın Unıversity
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1. Study Identification

Unique Protocol Identification Number
NCT05684926
Brief Title
COVID-19 Pandemic Asthma Child Telerehabilitation Yoga
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bartın Unıversity

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
In our study, yoga asana and pranayama practices, which will be applied by video call from computer or phone, will be advantageous in terms of time, transportation and access to asthmatic children whose anxiety and anxiety levels increase during the COVID-19 period, whose access to hospital services is difficult, and whose physical activity level decreases due to the increase in screen time. It was aimed to examine the effects of these group exercises on Asthma Control, Functional Capacity, Physical Fitness, Physical Activity and Quality of Life. In the randomized controlled study, the treatment and control group will be determined by the closed envelope method, the control group will be placed on the waiting list and yoga will be practiced at the end of the study. The first and final evaluation will be done face to face in a clinical setting. The total duration will be 12 weeks, 3 days a week and 36 sessions between 8-8:40 in the evening. Researchers who will do yoga have a certificate of practice. Patients will be followed up in Hacettepe University Medical Faculty Asthma Allergy Clinic.
Detailed Description
In our study, yoga asana and pranayama practices, which will be applied by video call from computer or phone, will be advantageous in terms of time, transportation and access to asthmatic children whose anxiety and anxiety levels increase during the COVID-19 period, whose access to hospital services is difficult, and whose physical activity level decreases due to the increase in screen time. It was aimed to examine the effects of these group exercises on Asthma Control, Functional Capacity, Physical Fitness, Physical Activity and Quality of Life. In the randomized controlled study, the treatment and control group will be determined by the closed envelope method, the control group will be placed on the waiting list and yoga will be practiced at the end of the study. The first and final evaluation will be done face to face in a clinical setting. Researchers who will do yoga have a certificate of practice. Patients will be followed up in Hacettepe University Medical Faculty Asthma Allergy Clinic. At the end of the study, pulmonary function assessment will be made for primary outcomes. Asthma control, functional testing, and quality of life will be evaluated for secondary outcomes. This study consists of a total of 36 sessions, 3 sessions per week for 12 weeks, and sessions of 40-50 minutes, and the measurements of these values at the beginning and after 36 sessions will be examined.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma in Children, Telerehabilitation, Yoga
Keywords
Asthma, Rehabilitation, Physical Fitness, Physical activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Telerehabilitation yoga
Other Intervention Name(s)
Yoga/Pranayama
Intervention Description
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.
Primary Outcome Measure Information:
Title
respiratory function (pulmoner function test)
Description
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.
Time Frame
one day
Secondary Outcome Measure Information:
Title
asthma control
Description
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).
Time Frame
one day
Title
functional capacity
Description
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.
Time Frame
one day
Title
physical fitness
Description
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.
Time Frame
one day
Title
physical activity
Description
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.
Time Frame
one day
Title
pediatric asthma quality of life questionnaire
Description
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.
Time Frame
one day
Title
pediatric reach test
Description
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.
Time Frame
one day
Title
periferic muscle test
Description
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.
Time Frame
one day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SEYMA NUR ÖNAL, Msc
Phone
+905382579630
Email
seymanurelskma@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
EBRU CALIK KUTUKCU, Phd
Phone
+905442850087
Email
ecalik85@gmail.com
Facility Information:
Facility Name
Hacettepe University
City
Ankara
State/Province
Altındağ
ZIP/Postal Code
06000
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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COVID-19 Pandemic Asthma Child Telerehabilitation Yoga

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