Aerobic Exercise in Children With Moderate and Severe Asthma

NCT ID: NCT01920529

Last Updated: 2013-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2013-03-31

Brief Summary

Regular aerobic physical activity in short-term moderate asthma and severe:

• Reduce the levels of inflammatory mediators
• Improves functional capacity
• Improves Quality of Life
• Improved lung function
• Reduces the sensation of dyspnea
• Improves symptoms scores and medication use

Detailed Description

Methods: Is designed a randomized clinical trial, efficacy, outpatient physical therapy developed in the Institute of Integrative Medicine Teacher Fernando Figueira (IMIP). A pilot study with 20 participants will be made initially to obtain a sample calculation. Subjectively estimated it will take about 50 participants, with possible losses. Will include children older than eight years, diagnosis of moderate and severe persistent asthma according to criteria of Global Initiative National Asthma (GINA) and forced expiratory volume in one minute (FEV1) below 80% predicted. Will be excluded from the study associated with disease that limits physical activity, such as neuromuscular diseases, congenital or acquired heart disease, chronic lung disease associated exacerbation of the crisis and significant cognitive deficit, which makes the participant to respond adequately to the questionnaire and / or inability to meet the commands. Eligible patients will be randomized into two groups: control group, which is not subjected to any kind of exercise and the intervention group, which will be submitted to aerobic exercise for 30 minutes three times a week for six weeks. The two groups will be evaluated before and at the end of six weeks by testing for 6-minute walk, analysis of dyspnea, questionnaire of quality of life, pulmonary function test (FEV1, FVC), inflammatory markers (cytokine ).

Conditions

Asthma

Keywords

asthma, aerobic exercise, child, cytokines

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

aerobic exercise

The study will consist of two groups: Group Comparison (GC) will be submitted to two evaluations at the beginning of a week and end of 6 weeks, without receiving any kind of physical training intervention. Group Training (GT) will undergo two assessments at the beginning of the end of the 1st and 6th week, however will be submitted to aerobic training for six weeks. Supervised aerobic training will be held three times a week for six weeks,treadmill in four consecutive steps each (05 minutes stretching, 05 minutes heating, 20 training minutes (1 st and 2 nd week) and 30 minutes (3 rd to 6 weeks) and cool down 05 minutes). The exercise intensity will be maintained through a desired percentage of heart rate for training (x%) from 70% to 80%, obtaining then the optimal heart rate training.

Group Type: EXPERIMENTAL

aerobic exercise

Intervention Type: OTHER

Performed aerobic exercise on a treadmill with cardiac predetermined frequency within 6 weeks and frequency of three times per week. All patients were monitored during training.

control

Investigators evaluated the distance walked during the 6-minute walk test and recorded variables such as heart rate, respiratory frequency, pulse oxygen saturation and a scale of perceived exertion (Borg) in the moments before and after the test. There was only evaluation without intervention.

Group Type: PLACEBO_COMPARATOR

aerobic exercise

Intervention Type: OTHER

Performed aerobic exercise on a treadmill with cardiac predetermined frequency within 6 weeks and frequency of three times per week. All patients were monitored during training.

Interventions

aerobic exercise

Performed aerobic exercise on a treadmill with cardiac predetermined frequency within 6 weeks and frequency of three times per week. All patients were monitored during training.

Intervention Type: OTHER

Other Intervention Names

physical exercise, physical training

Eligibility Criteria

Inclusion Criteria

• Age greater than eight and less than nineteen years
• Diagnosis of moderate to severe persistent asthma according to criteria of GINA
• forced expiratory volume in one minute (FEV1) below 80% of predicts
• Initiation of treatment with inhaled corticosteroids for at least eight weeks before the start of collection.

Exclusion Criteria

• associated disease that limits physical activity, such as neuromuscular disease, congenital or acquired, severe cor pulmonate, severe congenital malformation
• associated with chronic lung disease (cystic fibrosis, bronchiectasis, bronchopulmonary dysplasia, interstitial lung diseases
• significant cognitive deficit, which makes the participant to respond adequately to the questionnaire and / or failure to meet the commands
• exacerbation of crisis (This will be a temporary exclusion criterion, as having taken action as directed by medical routine, the participant can return to training)
• mental deficit.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Materno Infantil Prof. Fernando Figueira

OTHER

Sponsor Role: lead

Responsible Party

Livia Barboza de Andrade

PhD Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Livia B Andrade, PhD student

Role: PRINCIPAL_INVESTIGATOR

Professor of Pediatric Physical Therapy Specialization of integral medicine institute Prof. Fernando Figueira

Locations

Integral Medicine Institute Professor. Fernando Figueira-IMIP

Recife, Pernambuco, Brazil

Countries

Brazil

Other Identifiers

EASMADOC2013

Identifier Type: OTHER

Identifier Source: secondary_id

livia1971

Identifier Type: -

Identifier Source: org_study_id