Asthma ChildhoodTeleAssessmentNCT06026956
Tele-Assessment Methods in Children With Asthma
An observational study of Asthma Childhood, run by Bartın Unıversity.
Trial summary
Asthma is a chronic inflammatory disease of the airways. Childhood asthma is quite common. The airway responds unusually to triggers. There are episodes of recurrent wheezing, shortness of breath, chest tightness, and/or coughing that may change in intensity over time. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Asthma Childhood
- What is being tested?
- Tele-Assessment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2023to 15 Dec 2023
- Phase
- Observational
- 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
Study population: Asthmatic Child
Who may be able to join
- Hacettepe University Faculty of Medicine, Department of Pediatrics, Allergy and Asthma Unit patients referred for Cardiopulmonary Rehabilitation,
- Those who have been diagnosed with asthma,
- Clinically stable and not in active asthma attack,
- Between the ages of 6-11,
- Giving consent on a voluntary basis,
- cooperative,
- Ability to use a smart phone or computer,
- Individuals with internet connection will be included in the research.
Who cannot join
- Individuals with asthma were included in the study.
- Those whose clinical status is not stable and who are in active asthma attack,
- 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 do the tests,
- For safety reasons, patients admitted or hospitalized in the last 3 months due to an asthma attack will not be included in the study.
About this study
Official title: Validity and Reliability of Fitnessgram and Pediatric Functional Reach Tests Applied With Face-to-Face and Tele-Assessment Methods in Children With Asthma
Asthma is a chronic inflammatory disease of the airways. Childhood asthma is quite common. The airway responds unusually to triggers. There are episodes of recurrent wheezing, shortness of breath, chest tightness, and/or coughing that may change in intensity over time. Sudden contraction of airway smooth muscle may be reversible. It is characterized by common but also variable airflow obstruction. With the development of today's technology age, tele-assessment techniques allow professionals to remotely collect real-time data about the development of patients. It has been shown that video conferencing is a feasible and reliable method for evaluating patients with neurological symptoms. In a systematic study examining 41 articles investigating telehealth services and satisfaction; The findings show that patients are generally satisfied with the use of telemedicine. He argues that telemedicine is a low-cost model, increases access to health services, saves time, eliminates the need for travel, facilitates remote patient care and follow-up, and also improves health outcomes and/or quality. Therefore, the aim of our study; To compare the findings obtained with tele-assessment and clinical face-to-face evaluations on a scientific basis, where tele-applications are developing rapidly and their effectiveness has been proven by research, and according to the data to be obtained, an idea about the compatibility between remote evaluation of some parameters of asthmatic children such as physical fitness and flexibility, balance and face-to-face evaluations. is to own. In different situations where patients cannot reach the clinic (remote distance, pandemic, etc.), the evaluations to be made using the remote tele-assessment method can reflect the objective data and the continuity of the patient-health professional relationship can be maintained.
Read the detailed description
Asthma is a chronic inflammatory disease of the airways. Childhood asthma is quite common. The airway responds unusually to triggers. There are episodes of recurrent wheezing, shortness of breath, chest tightness, and/or coughing that may change in intensity over time. Sudden contraction of airway smooth muscle may be reversible. It is characterized by common but also variable airflow obstruction. Different classifications can be made according to age, symptoms, severity and inflammation in the school and pre-school period. Generally, allergic asthma is common. It is also possible to have atopic dermatitis, allergic rhinitis and food allergy in their personal and family history. In physical examination in children with asthma; They should be carefully examined for signs such as cyanosis, tachycardia, increased air trapping in the lungs, use of auxiliary respiratory muscles, intercostal/suprasternal/subcostal retractions, and difficulty in speaking. The degree of bronchospasm caused by physical activity differs from individual to individual and may vary daily depending on other triggers that the child is exposed to. Mucus accumulation due to the course of the disease, recurrent asthma attacks; It can cause pathological respiratory pattern, posture disorder and circulatory system disorders. In the later stages of the disease, continuous use of accessory respiratory muscles instead of the diaphragm leads to spinal immobility, shortening of the chest muscles, raised and dropped shoulders, forward tilt of the head, and shortening of the muscles around the hips and knees. In the chronic phase, inflammation of the lungs causes the body to deform. These negative physical changes can lead to problems with physical fitness and balance. Physical assessment plays a key role in detecting dysfunctions and activity limitations, establishing the rehabilitation program and determining its effectiveness. With the development of today's technology age, tele-assessment techniques allow professionals to remotely collect real-time data about the development of patients. It has been shown that video conferencing is a feasible and reliable method for evaluating patients with neurological symptoms. In a systematic study examining 41 articles investigating telehealth services and satisfaction; The findings show that patients are generally satisfied with the use of telemedicine. He argues that telemedicine is a low-cost model, increases access to health services, saves time, eliminates the need for travel, facilitates remote patient care and follow-up, and also improves health outcomes and/or quality. Therefore, the aim of our study; To compare the findings obtained with tele-assessment and clinical face-to-face evaluations on a scientific basis, where tele-applications are developing rapidly and their effectiveness has been proven by research, and according to the data to be obtained, an idea about the compatibility between remote evaluation of some parameters of asthmatic children such as physical fitness and flexibility, balance and face-to-face evaluations. is to own. In different situations where patients cannot reach the clinic (remote distance, pandemic, etc.), the evaluations to be made using the remote tele-assessment method can reflect the objective data and the continuity of the patient-health professional relationship can be maintained. The investigators also think that asthmatic children, whose physical evaluations can be made remotely with the data to be obtained, may have advantages such as transportation, weather conditions, school attendance, control of triggers (crowded environments, cigarette smoke, polluted air, etc.). The interviews will be recorded on the computer of the principal investigator and personal data will be recorded in accordance with the Personal Data Protection Law, the law and the rules of honesty, accurate and when necessary, for current, specific, clear and legitimate purposes, in connection with the purpose for which they are processed, limited and measured, for the purpose stipulated in the relevant legislation or for the purpose for which they are processed. Preservation rules will be followed for as long as necessary.
- Conditions
- Asthma Childhood
- Being tested
- Tele-Assessment
- Keywords
- Asthma Childhood, Tele-assessment, Fitness Test, Reach Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-AssessmentOther
Tele-Assessment
What is being measured
The primary outcome is the main question the study is designed to answer.
FİTNESSGRAM (a)Sit and lie down test with back support:
The test, which measures physical fitness parameters, can be applied to 5 inpatients. Appropriate cut-off points are specified in the application guide.
(a)Sit and lie down test with back support: While sitting, the person extends his foot and leans on the bench and bends the other lower extremity. The hands are stretched forward four times in a row and the fourth distance is recorded.
Measured: one day
FİTNESSGRAM (b)Trunk Extension-extension test:
(b)Trunk Extension-extension test: The person lies face down with the hands under the thighs. He lifts his body twice, looking at a coin. In the second, the distance between the chin and the cushion is recorded.
Measured: one day
FİTNESSGRAM (c)Trunk Flexion flexion test:
(c)Trunk Flexion flexion test: The person lies on his back with the knees bent and touches the fixed band on the sides at hand level with the fingertips. Lifts the trunk in a repeat rhythm (every three seconds). It does not move from the lane while rubbing its hands. The number of repetitions performed correctly in accordance with the rhythm is noted.
Measured: one day
FİTNESSGRAM (d)Push-up test:
(d)Push-up test: The person is face down and the hands are shoulder-width apart. The chest moves up and down, with the elbows locked and unlocked (every three seconds) without bending the body. The number of repetitions is noted.
Measured: one day
FİTNESSGRAM (e) Progressive aerobic cardiovascular endurance test (PACER):
(e) Progressive aerobic cardiovascular endurance test (PACER): The set time to reach 20 meters is 9 seconds. 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
Secondary outcomes (1)
Pediatric Reach Test
Evaluates the dynamic component of balance. It has validity and reliability for healthy and disabled children. The test is performed by recording the distance, in cm, at which the subjects can reach forward, then to the right and left, respectively, in sitting (with the hip and knee flexed to 90 degrees, in a chair without side and back support) and standing upright positions without lifting their heels off the ground.
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 posted7 Sep 2023
- Study start15 Sep 2023 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma ChildhoodStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
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
- NCT06026956
- Sponsor's protocol ID
- GO23/26
- Acronym
- TeleAssessment
- Status last verified
- Sep 2023
- First submitted
- 9 Aug 2023
- Last updated
- 7 Sep 2023
- 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 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of Fitnessgram and Pediatric Functional Reach Tests Applied With Face-to-Face and Tele-Assessment Methods in Children With Asthma
- ClinicalTrials.gov ID
- NCT06026956
- Acronym / sponsor ID
- TeleAssessment / GO23/26
- Conditions
- Asthma Childhood
- Keywords
- Asthma Childhood, Tele-assessment, Fitness Test, Reach Test
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Bartın UnıversityUniversity, hospital or other
- Study start
- 15 Sep 2023 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 7 Sep 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.
Asthma is a chronic inflammatory disease of the airways. Childhood asthma is quite common. The airway responds unusually to triggers. There are episodes of recurrent wheezing, shortness of breath, chest tightness, and/or coughing that may change in intensity over time. Sudden contraction of airway smooth muscle may be reversible. It is characterized by common but also variable airflow obstruction. With the development of today's technology age, tele-assessment techniques allow professionals to remotely collect real-time data about the development of patients. It has been shown that video conferencing is a feasible and reliable method for evaluating patients with neurological symptoms. In a systematic study examining 41 articles investigating telehealth services and satisfaction; The findings show that patients are generally satisfied with the use of telemedicine. He argues that telemedicine is a low-cost model, increases access to health services, saves time, eliminates the need for travel, facilitates remote patient care and follow-up, and also improves health outcomes and/or quality. Therefore, the aim of our study; To compare the findings obtained with tele-assessment and clinical face-to-face evaluations on a scientific basis, where tele-applications are developing rapidly and their effectiveness has been proven by research, and according to the data to be obtained, an idea about the compatibility between remote evaluation of some parameters of asthmatic children such as physical fitness and flexibility, balance and face-to-face evaluations. is to own. In different situations where patients cannot reach the clinic (remote distance, pandemic, etc.), the evaluations to be made using the remote tele-assessment method can reflect the objective data and the continuity of the patient-health professional relationship can be maintained.
Detailed description
Asthma is a chronic inflammatory disease of the airways. Childhood asthma is quite common. The airway responds unusually to triggers. There are episodes of recurrent wheezing, shortness of breath, chest tightness, and/or coughing that may change in intensity over time. Sudden contraction of airway smooth muscle may be reversible. It is characterized by common but also variable airflow obstruction. Different classifications can be made according to age, symptoms, severity and inflammation in the school and pre-school period. Generally, allergic asthma is common. It is also possible to have atopic dermatitis, allergic rhinitis and food allergy in their personal and family history. In physical examination in children with asthma; They should be carefully examined for signs such as cyanosis, tachycardia, increased air trapping in the lungs, use of auxiliary respiratory muscles, intercostal/suprasternal/subcostal retractions, and difficulty in speaking. The degree of bronchospasm caused by physical activity differs from individual to individual and may vary daily depending on other triggers that the child is exposed to. Mucus accumulation due to the course of the disease, recurrent asthma attacks; It can cause pathological respiratory pattern, posture disorder and circulatory system disorders. In the later stages of the disease, continuous use of accessory respiratory muscles instead of the diaphragm leads to spinal immobility, shortening of the chest muscles, raised and dropped shoulders, forward tilt of the head, and shortening of the muscles around the hips and knees. In the chronic phase, inflammation of the lungs causes the body to deform. These negative physical changes can lead to problems with physical fitness and balance. Physical assessment plays a key role in detecting dysfunctions and activity limitations, establishing the rehabilitation program and determining its effectiveness. With the development of today's technology age, tele-assessment techniques allow professionals to remotely collect real-time data about the development of patients. It has been shown that video conferencing is a feasible and reliable method for evaluating patients with neurological symptoms. In a systematic study examining 41 articles investigating telehealth services and satisfaction; The findings show that patients are generally satisfied with the use of telemedicine. He argues that telemedicine is a low-cost model, increases access to health services, saves time, eliminates the need for travel, facilitates remote patient care and follow-up, and also improves health outcomes and/or quality. Therefore, the aim of our study; To compare the findings obtained with tele-assessment and clinical face-to-face evaluations on a scientific basis, where tele-applications are developing rapidly and their effectiveness has been proven by research, and according to the data to be obtained, an idea about the compatibility between remote evaluation of some parameters of asthmatic children such as physical fitness and flexibility, balance and face-to-face evaluations. is to own. In different situations where patients cannot reach the clinic (remote distance, pandemic, etc.), the evaluations to be made using the remote tele-assessment method can reflect the objective data and the continuity of the patient-health professional relationship can be maintained. The investigators also think that asthmatic children, whose physical evaluations can be made remotely with the data to be obtained, may have advantages such as transportation, weather conditions, school attendance, control of triggers (crowded environments, cigarette smoke, polluted air, etc.). The interviews will be recorded on the computer of the principal investigator and personal data will be recorded in accordance with the Personal Data Protection Law, the law and the rules of honesty, accurate and when necessary, for current, specific, clear and legitimate purposes, in connection with the purpose for which they are processed, limited and measured, for the purpose stipulated in the relevant legislation or for the purpose for which they are processed. Preservation rules will be followed for as long as necessary.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Asthmatic Child
Key inclusion criteria (8 listed)
- Hacettepe University Faculty of Medicine, Department of Pediatrics, Allergy and Asthma Unit patients referred for Cardiopulmonary Rehabilitation,
- Those who have been diagnosed with asthma,
- Clinically stable and not in active asthma attack,
- Between the ages of 6-11,
- Giving consent on a voluntary basis,
Key exclusion criteria (7 listed)
- Individuals with asthma were included in the study.
- Those whose clinical status is not stable and who are in active asthma attack,
- 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 |
|---|---|---|
| Tele-AssessmentTele-Assessment | Other | – |
Primary outcome
FİTNESSGRAM (a)Sit and lie down test with back support:
Time frame: one day
The test, which measures physical fitness parameters, can be applied to 5 inpatients. Appropriate cut-off points are specified in the application guide. (a)Sit and lie down test with back support: While sitting, the person extends his foot and leans on the bench and bends the other lower extremity. The hands are stretched forward four times in a row and the fourth distance is recorded.
FİTNESSGRAM (b)Trunk Extension-extension test:
Time frame: one day
(b)Trunk Extension-extension test: The person lies face down with the hands under the thighs. He lifts his body twice, looking at a coin. In the second, the distance between the chin and the cushion is recorded.
FİTNESSGRAM (c)Trunk Flexion flexion test:
Time frame: one day
(c)Trunk Flexion flexion test: The person lies on his back with the knees bent and touches the fixed band on the sides at hand level with the fingertips. Lifts the trunk in a repeat rhythm (every three seconds). It does not move from the lane while rubbing its hands. The number of repetitions performed correctly in accordance with the rhythm is noted.
FİTNESSGRAM (d)Push-up test:
Time frame: one day
(d)Push-up test: The person is face down and the hands are shoulder-width apart. The chest moves up and down, with the elbows locked and unlocked (every three seconds) without bending the body. The number of repetitions is noted.
FİTNESSGRAM (e) Progressive aerobic cardiovascular endurance test (PACER):
Time frame: one day
(e) Progressive aerobic cardiovascular endurance test (PACER): The set time to reach 20 meters is 9 seconds. 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.
1 secondary outcome
Pediatric Reach Test
Time frame: one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Asthma Childhood
Recruiting
Effects of Tele-rehabilitation-Guided Qigong on Children and Adolescents With Asthma
Asthma Childhood
RecruitingObservational study
Remote Monitoring of Asthma in Children and Young People
Asthma Childhood, Asthma Attack
Active, not recruiting
Community Health Equity Accelerator (CHEA) Pediatric Asthma Intervention
Asthma in Children
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Active, not recruiting
Technology-Enhanced Asthma Care in Children at Clinic and Home Study
Asthma in Children, Chronic Diseases in Children
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma Childhood, run by Bartın Unıversity.
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 8 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
FİTNESSGRAM (a)Sit and lie down test with back support: (time frame: one day). The study lists 5 primary outcomes in all. 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 7 Sep 2023.