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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Asthma in Children
- Sponsor
- Universidade Norte do Paraná
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Sedentary behavior
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Karina Furlanetto
Professor
Universidade Norte do Paraná
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.
Outcomes
Primary Outcomes
Sedentary behavior
Time Frame: 12 weeks from randomization
Time spent (in minutes and percentage of the day) in sedentary activities, measured by a triaxial activity monitor.
The activity of daily living
Time Frame: 12 weeks from randomization
Time on a specific test to evaluate activities of daily living in children
Physical activity
Time Frame: 12 weeks from randomization
Number of steps per day, time spent (in minutes and percentage of the day) in light-intensity and moderate to vigorous physical activities, measured by a triaxial activity monitor.
Secondary Outcomes
- Initial assessment about general characteristics and health status(12 weeks from randomization)
- Pulmonary Function(12 weeks from randomization)
- Quality of life in asthma(12 weeks from randomization)
- Parents' knowledge about the child's illness(12 weeks from randomization)
- Asthma Control(12 weeks from randomization)
- Exacerbation and medication diary(12 weeks from randomization)
- Sleep assessment(12 weeks from randomization)
- Family Health Questionnaire(12 weeks from randomization)
- Motivation scale(12 weeks from randomization)
- Report of performance in physical activities(12 weeks from randomization)
- Submaximal exercise capacity(12 weeks from randomization)
- Maximal exercise capacity(12 weeks from randomization)