Pulmonary Rehabilitation in Asthmatic Patient

Children Clinical Trial

Official title:

Pulmonary Rehabilitation in Asthmatic Pediatric Patients: Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02383069
• Other study ID #: CPR-UNI9
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: August 2018

Study information

• Verified date: August 2019
• Source: University of Nove de Julho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: August 2018
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthmatic
• Children

Intervention

Other:
• Intervention Group
Aerobic training
• Control Group
Chest physiotherapy: Flutter and muscle stretching

Locations

Country	Name	City	State
Brazil	Fernanda C Lanza	Sao Paulo

Sponsors (4)

Lead Sponsor	Collaborator
Fernanda de Cordoba Lanza	Federal University of Minas Gerais, Fundação de Amparo à Pesquisa do Estado de São Paulo, University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	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).
Secondary	Quality of life measured by Pediatric questionnaire		Quesitionnaire will be measured at the begening and at the end of the protocol (after 8 weeks).
Secondary	Inflammatory markers as measure by interleukines		Inflamatory markers will be measured at the begening and at the end of the protocol (after 8 weeks).