Pulmonary Rehabilitation in Asthmatic Patient

Study Overview
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Brief Summary
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Asthma is one of the main chronic diseases in childhood and it is characterized by the inflammation of airways. Individuals with chronic lung disease are more susceptible to present reduction in exercise tolerance due to pulmonary limitations. The pulmonary rehabilitation may improve the physical capacity in asthmatic patients, as observed in other chronic lung diseases.

Detailed Description
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The asthmatic patient's clinical changes may impair their functional capacity and exercise tolerance. Thus, the treatment of these individuals should be extended to pulmonary rehabilitation. Randomized clinical trials have shown interesting results, whether in cardiopulmonary conditions, quality of life or in the number of crises, after applying pulmonary rehabilitation program in asthmatic children and adolescents. In a systematic review on physical training with asthmatic children and adolescents the authors concluded that physical activity should be recommended to this population, although some issues have not yet been clarified due to limitations in the clinical trial. The control of the disease has not been evaluated by specific questionnaires in any study. The assessment of inflammatory markers was rarely addressed and the same occurred in the quality of life after physical training. In addition, it is possible to question the intensity and frequency of training, factors that can significantly contribute to the intervention results. All these information let us know that is necessary a randomized control trial to answer questions about physical characteristics, quality of life, inflammatory markers, and muscles strength.

Official Title
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Pulmonary Rehabilitation in Asthmatic Pediatric Patients: Randomized Clinical Trial

Conditions
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Asthmatic, Children

Intervention / Treatment
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* Other: Intervention Group
* Other: Control Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: between six and 18 years old asthma-diagnosed patients under medical treatment and disease control Exclusion Criteria: fail to carry out the protocol evaluations interrupt the medical care and/or drug-based treatment acute lung infection or other chronic lung diseases other comorbidities (neuropathies, heart disease) missing in more than 20% the rehabilitation protocol

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>The intervention group will have supervised rehabilitation program held twice a week, each session will have 60 minutes duration, with minimum interval of 24 hours, for a period of 8 weeks. Each session will consist of three parts: aerobic training, strength training and respiratory physiotherapy. The aerobic training will be held for 35 minutes (10 min of warm up, 20 min on target load and 5 min of slowdown) with initial intensity of 60% of the maximum load obtained in the maximal cardiopulmonary exercise testing or in incremental shuttle walk test (ISWT). The intensity will be gradually increased up to 80%, so that fatigue or dyspnea values are kept between 4 and 6, according to the modified Borg scale. | Other: Intervention Group<br>* Aerobic training<br>* Other names: Pulmonary Rehabilitation;|
| Active Comparator: Control Group<br>The control group will be subjected to supervised respiratory physiotherapy and stretching exercises twice a week, each session with duration of 60 minutes, with minimum interval of 24 hours, for a period of 8 weeks. The oral high-frequency oscillation device (Flutter®) will be used for 10 minutes, 5 minutes in each lateral decubitus, followed by the stretching of upper and lower limbs for 40 minutes. All exercises will be active, performed in sitting and lying positions without increasing the heart rate. The remaining 10 minutes will be used to discuss doubts about the disease and the use of the booklet. | Other: Control Group<br>* Chest physiotherapy: Flutter and muscle stretching<br>* Other names: Chest Physiotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical capacity as measure by distance walked of shuttle walk test and oxygen consumption (VO2) | Modified shuttle test was conducted | Physiscal capacity will be measured at the beginning and at the end of the protocol (after 8 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength as measure by electromyography (EMG) | 1 maximal repetition was performed | Muscles strenght will be measured at the begening and at the end of the protocol (after 8 weeks). | 
| Muscle endurance as measure by electromyography (EMG) |  | Muscles endurance will be measured at the begening and at the end of the protocol (after 8 weeks). | 
| Quality of life measured by Pediatric questionnaire |  | Quesitionnaire will be measured at the begening and at the end of the protocol (after 8 weeks). | 
| Inflammatory markers as measure by interleukines |  | Inflamatory markers will be measured at the begening and at the end of the protocol (after 8 weeks). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary rehabilitation, Asthma, Children, Teenager, Physical capacity