Pulmonary Rehabilitation in Asthmatic Patient

Not Applicable

Completed

• Conditions: Asthmatic; Children

• Registration Number: NCT02383069
• Lead Sponsor: Fernanda de Cordoba Lanza

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.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-10
• Study First Submitted QC: 2015-03-03
• Study First Posted: 2015-03-09
• Primary Completion: 2016-07
• Study Completion: 2018-08
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-05
• Last Update Posted: 2019-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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).
Muscle strength as measure by electromyography (EMG)	Muscles strenght will be measured at the begening and at the end of the protocol (after 8 weeks).	1 maximal repetition was performed
Inflammatory markers as measure by interleukines	Inflamatory markers will be measured at the begening and at the end of the protocol (after 8 weeks).

Trial Locations

Locations (1)

Fernanda C Lanza; 🇧🇷 Sao Paulo, Brazil