- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06053905
Dynamic Respiratory Muscle Strength and Endurance in Childhood Asthma
Comparison of Dynamic Respiratory Muscle Strength and Endurance, Physical Activity Level and Physical Fitness in Asthmatic Children and Their Healthy Peers
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Seyma Nur Onal, MsC
- Phone Number: +905382579630
- Email: seymanurelskma@gmail.com
Study Contact Backup
- Name: Ebru Calik Kutukcu, PhD
- Phone Number: +905442850087
- Email: ecalik85@gmail.com
Study Locations
-
-
Altındağ
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Ankara, Altındağ, Turkey, 06100
- Recruiting
- Ebru Çalik Kütükcü
-
Contact:
- Ebru Calik Kutukcu
- Phone Number: +905442850087
- Email: ecalik85@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria for Asthmatic Group Research:
- 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,
Asthmatic Group Exclusion Criteria:
- 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.
Healthy Group Inclusion Criteria:
- Not having any chronic disease for healthy individuals,
- be between the ages of 6-11,
- Volunteering to participate in the study,
- Not having speech and hearing problems,
- Being cooperative,
- Not having a mental, neurological, orthopedic, cardiovascular or pulmonary problem that would prevent physical activity,
Healthy Group Exclusion Criteria:
- The presence of a medical indication that requires complete restriction of physical activity,
- Having symptoms of any chronic or acute illness involving the lungs
- Existence of cooperation and communication problems
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Asthmatic Child
Children with asthma between 6-11 years old
|
Healthy Controls Group
Healthy children between 6-11 years old
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dynamic Respiratory Muscle Strength and Endurance
Time Frame: Day 1
|
POWERbreathe K-Series, K5, intelligent digital breathing trainers, The first 2 breaths should be taken as quickly and deeply as possible.
During these breaths, the maximum respiratory capacity is measured.
The index of the power indicator ranges from 10 to 240 cm H2O.
Higher values are better.
For hygiene reasons, the test is done with a disposable mouthpiece.
|
Day 1
|
Pulmonary Function Test
Time Frame: Day 1
|
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.
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
6 Minutes Walking Test
Time Frame: Day 1
|
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 six minute walk test will be measured by the 6 Minute Walk Test.
You can walk at a fast pace for 6 minutes without running in a 30 m long corridor.
The distance walked is recorded in meters.
|
Day 1
|
Physical Activity Questionnaire
Time Frame: Day 1
|
It is a 5-point liket questionnaire consisting of 10 questions created to determine the physical activity level of children for the last 1 week.
|
Day 1
|
FITNESSGRAM (a) Sit and lie down test with back support:
Time Frame: Day 1
|
FITNESSGRAM is a physical fitness test with its own guide. There are cut-off values according to age and gender. (a) Sit and lie down test with back support: While sitting, the person extends his foot and bends the other lower extremity. The hands are stretched forward four times in a row and the fourth distance is recorded. |
Day 1
|
FITNESSGRAM (b) Trunk Extension-extension test:
Time Frame: Day 1
|
(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.
|
Day 1
|
FITNESSGRAM (c) Trunk Flexion flexion test:
Time Frame: Day 1
|
(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.
|
Day 1
|
FITNESSGRAM (d) Push-up test:
Time Frame: Day1
|
(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.
|
Day1
|
FITNESSGRAM (e) PACER test
Time Frame: Day 1
|
(PACER test): The PACER test is a progressive aerobic cardiovascular endurance run.
It is done on a 20-meter course.
He jogs at an accelerating rhythm (decreasing by half a second every minute).
The test ends if the rhythm is missed or the line is not reached before two beeps.
The number of laps is recorded.
|
Day 1
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ebru Calik Kutukcu, PhD, Hacettepe University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Other Study ID Numbers
- GO23/241
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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