Clinical trial NCT02383069: Pulmonary Rehabilitation in Asthmatic Patient
Official title: Pulmonary Rehabilitation in Asthmatic Pediatric Patients: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthmatic
Children
Keywords: Pulmonary rehabilitation
Asthma
Children
Teenager
Physical capacity
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
Collaborators: name: University of Nove de Julho
name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Federal University of Minas Gerais
First posted: 2015-03-09
Enrollment: 66
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Physical capacity as measure by distance walked of shuttle walk test and oxygen consumption (VO2)
timeFrame: Physiscal capacity will be measured at the beginning and at the end of the protocol (after 8 weeks)
Secondary outcomes:
measure: Muscle strength as measure by electromyography (EMG)
timeFrame: Muscles strenght will be measured at the begening and at the end of the protocol (after 8 weeks).
measure: Muscle endurance as measure by electromyography (EMG)
timeFrame: Muscles endurance will be measured at the begening and at the end of the protocol (after 8 weeks).
measure: Quality of life measured by Pediatric questionnaire
timeFrame: Quesitionnaire will be measured at the begening and at the end of the protocol (after 8 weeks).
measure: Inflammatory markers as measure by interleukines
timeFrame: Inflamatory markers will be measured at the begening and at the end of the protocol (after 8 weeks).
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Fernanda C Lanza
Study officials:
affiliation: Unifesp, Federal University of Sao Paulo
name: Dirceu Solé, PhD
role: STUDY_CHAIR
References:
citation: Silva EP, Soares BA, Reimberg MM, Ritti-Dias R, Nascimento KS, Anjos FS, Wandalsen GF, Sole D, Dal Corso S, Lanza FC. Heart rate recovery in asthmastic children and adolescents after clinical field test. BMC Pulm Med. 2021 Feb 19;21(1):61. doi: 10.1186/s12890-020-01355-9.
citation: Reimberg MM, Castro RA, Selman JP, Meneses AS, Politti F, Mallozi MC, Wandalsen GF, Sole D, De Angelis K, Dal Corso S, Lanza FC. Effects of a pulmonary rehabilitation program on physical capacity, peripheral muscle function and inflammatory markers in asthmatic children and adolescents: study protocol for a randomized controlled trial. Trials. 2015 Aug 13;16:346. doi: 10.1186/s13063-015-0876-x.