Clinical trial NCT06141616: Effects of Pulmonary Rehabilitation on Clinical Outcomes in Children With Asthma
Official title: Effects of Pulmonary Rehabilitation on Activities of Daily Living, Physical Activities of Daily Living and Other Clinical Outcomes in Children With Asthma: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Asthma in Children
Physical Inactivity
Lead sponsor: Universidade Norte do Paraná
Sponsor class: OTHER
First posted: 2023-11-21
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although the practice of physical activity is recommended for children with asthma, the scientific literature available so far has focused mainly on improving functional capacity and quality of life. However, the effects of pulmonary rehabilitation in this population, especially in improving the level of physical activity in daily living (PADL) and activities of daily living (ADLs) have not yet been investigated in depth. Therefore, the objective of this study is to verify the effects of pulmonary rehabilitation on PADL, ADL, and other clinical outcomes of children with asthma. For this, a randomized clinical trial will be carried out that will have 2 groups: the control group (CG), which will receive only educational sessions, and the intervention group (IG) which will participate in a pulmonary rehabilitation program with supervised aerobic training performed three times a week with sessions of 60 minutes each. The total duration of interventions in both groups will be 12 weeks. The primary outcomes of this study are PADL (assessed using a physical activity monitor - Actigraph) and ADL; however, the following will also be evaluated: lung function, functional capacity, asthma control, and quality of life. We hypothesized that the performance of regular physical activity and supervised physical exercise by individuals with asthma could positively impact health outcomes with better control of asthma symptoms, better performance in ADL and PADL, and better quality of life.


Eligibility criteria: Inclusion Criteria:

* Age between 6 and 12 years old;
* Clinical diagnosis of asthma, established according to the criteria of the Global Initiative for Asthma (GINA);
* Absence of other lung diseases or signs and symptoms of other lung diseases;
* Absence of cognitive changes;
* Absence of signs and symptoms of gastroesophageal reflux disease and dysphagia;
* Clinical stability according to the criteria of the Global Initiative for Asthma (GINA);

Exclusion Criteria:

* Desire of the patient and/or the patient's family to discontinue participation in the study for any reason;
* Present some new limitations that may interfere with functionality;
* Comorbidities that prevent or contraindicate the performance of the proposed interventions.

Primary outcomes:
measure: Physical activity
timeFrame: 12 weeks from randomization
measure: Sedentary behavior
timeFrame: 12 weeks from randomization
measure: The activity of daily living
timeFrame: 12 weeks from randomization
Secondary outcomes:
measure: Initial assessment about general characteristics and health status
timeFrame: 12 weeks from randomization
measure: Pulmonary Function
timeFrame: 12 weeks from randomization
measure: Asthma Control
timeFrame: 12 weeks from randomization
measure: Exacerbation and medication diary
timeFrame: 12 weeks from randomization
measure: Quality of life in asthma
timeFrame: 12 weeks from randomization
measure: Sleep assessment
timeFrame: 12 weeks from randomization
measure: Parents' knowledge about the child's illness
timeFrame: 12 weeks from randomization
measure: Family Health Questionnaire
timeFrame: 12 weeks from randomization
measure: Report of performance in physical activities
timeFrame: 12 weeks from randomization
measure: Motivation scale
timeFrame: 12 weeks from randomization
measure: Submaximal exercise capacity
timeFrame: 12 weeks from randomization
measure: Maximal exercise capacity
timeFrame: 12 weeks from randomization
Other outcomes:
Locations:
city: Londrina
country: Brazil
facility: Centro de Pesquisa e Pós Graduação na Unopar
state: Paraná
Study officials:
affiliation: Universidade Norte do Paraná
name: Vitória Puzzi, Msc
role: PRINCIPAL_INVESTIGATOR
References: