Asthma in ChildrenNCT05684926
COVID-19 Pandemic Asthma Child Telerehabilitation Yoga
A study testing Telerehabilitation yoga in people with Asthma in Children and Telerehabilitation, run by Bartın Unıversity at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Asthma in Children, Telerehabilitation, Yoga
- What is being tested?
- Telerehabilitation yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 15 May 2023
- 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 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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,
Who cannot join
- 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,
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Asthma in Children, Telerehabilitation, Yoga
- Being tested
- Telerehabilitation yoga
- Keywords
- Asthma, Rehabilitation, Physical Fitness, Physical activity
- Medical subject headings
- Asthma, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation yogaOther
Also called Yoga/Pranayama
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | 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. Receives: Other: Telerehabilitation yoga |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one day
Secondary outcomes (7)
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).
Measured: one day
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.
Measured: one day
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.
Measured: one day
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.
Measured: one day
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.
Measured: one day
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.
Measured: one day
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.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start1 Sep 2022
- Primary completion15 Oct 2022
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bartın Unıversity
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şeyma Nur Önal, Bartın Unıversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684926
- Sponsor's protocol ID
- KA22030
- Status last verified
- Mar 2024
- First submitted
- 12 Jan 2023
- Last updated
- 15 Mar 2024
- 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 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05684926
- Acronym / sponsor ID
- KA22030
- Conditions
- Asthma in Children, Telerehabilitation, Yoga
- Keywords
- Asthma, Rehabilitation, Physical Fitness, Physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Bartın UnıversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 13 Jan 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Telerehabilitation yogaThe 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (9 listed)
- 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,
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 |
|---|---|---|
| Telerehabilitation yogaAlso: Yoga/PranayamaYoga 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 | Experimental Group |
Primary outcome
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.
7 secondary outcomes
asthma control
Time frame: one day
functional capacity
Time frame: one day
physical fitness
Time frame: one day
physical activity
Time frame: one day
pediatric asthma quality of life questionnaire
Time frame: one day
pediatric reach test
Time frame: one day
periferic muscle test
Time frame: one day
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 15 Mar 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation yoga in people with Asthma in Children and Telerehabilitation, run by Bartın Unıversity at 1 site 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 7 inclusion and 9 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 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
respiratory function (pulmoner function test) (time frame: one day). 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 15 Mar 2024; AzTrials last refreshed its copy on 8 Nov 2026.