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Completed

NCT Number: NCT02383069

Pulmonary Rehabilitation in Asthmatic Patient

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.

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Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fernanda C Lanza

São Paulo, 01504001, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention group

Other

Aerobic training

Other names: Pulmonary Rehabilitation

Control Group

Other

Chest physiotherapy: Flutter and muscle stretching

Other names: Chest Physiotherapy

Primary outcomes

  1. Physical capacity as measure by distance walked of shuttle walk test and oxygen consumption (VO2)

    Time frame: Physiscal capacity will be measured at the beginning and at the end of the protocol (after 8 weeks)

    Modified shuttle test was conducted

Secondary outcomes

  1. Muscle strength as measure by electromyography (EMG)

    Time frame: Muscles strenght will be measured at the begening and at the end of the protocol (after 8 weeks).

    1 maximal repetition was performed

  2. Muscle endurance as measure by electromyography (EMG)

    Time frame: Muscles endurance will be measured at the begening and at the end of the protocol (after 8 weeks).

  3. Quality of life measured by Pediatric questionnaire

    Time frame: Quesitionnaire will be measured at the begening and at the end of the protocol (after 8 weeks).

  4. Inflammatory markers as measure by interleukines

    Time frame: Inflamatory markers will be measured at the begening and at the end of the protocol (after 8 weeks).

Sponsors and collaborators

Lead sponsor

Fernanda de Cordoba Lanza

Other

Collaborators

  • Federal University of Minas Gerais
  • Fundação de Amparo à Pesquisa do Estado de São Paulo
  • University of Nove de Julho

Registry information

Official study title

Pulmonary Rehabilitation in Asthmatic Pediatric Patients: Randomized Clinical Trial

Important dates

Study start
2015
Primary completion
2016
Study completion
2018
First posted
Mar 9, 2015
Registry last updated
Aug 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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