Clinical trial NCT06053905: Dynamic Respiratory Muscle Strength and Endurance in Childhood Asthma
Official title: Comparison of Dynamic Respiratory Muscle Strength and Endurance, Physical Activity Level and Physical Fitness in Asthmatic Children and Their Healthy Peers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma in Children
Keywords: Asthma Childhood
Respiratory Muscle
Physical Activity
Fitness
Lead sponsor: Bartın Unıversity
Sponsor class: OTHER
Collaborators: name: Hacettepe University
First posted: 2023-09-26
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: asthmatic child and healthly peers

Brief summary: Peak inspiratory flow (PIF) may be due to respiratory muscle strength, especially in those with severe airflow obstruction. PIF appears to be lower in children and adolescents with asthma than in non-asthmatics and correlates positively with age, height, weight, and respiratory muscle strength. Although physical activity and fitness are also believed to be important in lung health, the relationship between lung function and physical fitness is unclear. It measures dynamic lung volumes, s-index and PIF and provides information on dynamic lung function in children and adolescents. In this study, the dynamic components of the lung will be compared between asthmatic and healthy children, and the relationship between respiratory parameters and physical assessment, such as physical fitness, activity and functional capacity, will be investigated in children with asthma.

Detailed description: Asthma prevalence is high in childhood and adolescence and the disease imposes an economic burden. In studies, patients with peak inspiratory flow (PIF) showed variability in severe obstruction and a dependence on respiratory muscle strength. PIF appears to be lower in children and adolescents with asthma than in those without asthma and correlates positively with age, height, weight and respiratory muscle strength. Also, although physical activity and fitness are believed to be important in lung health, the relationship between lung function and physical fitness is unclear. Physical activity improves exercise capacity and outcomes in patients with asthma or chronic obstructive pulmonary disease, but there is insufficient evidence that it improves lung function. Physical fitness in childhood and adolescence has been associated with increases in lung volumes throughout early adulthood. These relationships may weaken with age and may not be significant in older age groups. s-Index (a special calculation) and PIF describe dynamic lung volumes. There are very few studies in the literature that dynamically evaluate respiratory muscles and functions compared to their healthy counterparts and interpret these tests together with physical evaluations. In addition, reference values for the s-index and PIF in children with asthma are uncertain due to the small number of studies. The results of this study will contribute to future studies in determining the test reference values.The investigators think that the results of the study will contribute to future studies in determining the test reference values.

Eligibility criteria: 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

Primary outcomes:
measure: Dynamic Respiratory Muscle Strength and Endurance
timeFrame: Day 1
measure: Pulmonary Function Test
timeFrame: Day 1
Secondary outcomes:
measure: 6 Minutes Walking Test
timeFrame: Day 1
measure: Physical Activity Questionnaire
timeFrame: Day 1
measure: FITNESSGRAM (a) Sit and lie down test with back support:
timeFrame: Day 1
measure: FITNESSGRAM (b) Trunk Extension-extension test:
timeFrame: Day 1
measure: FITNESSGRAM (c) Trunk Flexion flexion test:
timeFrame: Day 1
measure: FITNESSGRAM (d) Push-up test:
timeFrame: Day1
measure: FITNESSGRAM (e) PACER test
timeFrame: Day 1
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ebru Çalik Kütükcü
state: Altındağ
Study officials:
affiliation: Hacettepe University
name: Ebru Calik Kutukcu, PhD
role: PRINCIPAL_INVESTIGATOR
References: