Aerobic Exercise in Children With Moderate and Severe Asthma
AECA
Effectiveness of a Physical Training Program on Inflammatory Response, Functional Capacity and Quality Life in Children With Moderate and Severe Asthma.
2 other identifiers
interventional
50
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable asthma
Started Aug 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 13, 2013
CompletedFirst Posted
Study publicly available on registry
August 12, 2013
CompletedAugust 12, 2013
August 1, 2013
1.6 years
May 13, 2013
August 8, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Inflammatory mediators by analyzing cytokines by flow cytometry
Was carried collection of peripheral blood cells separated and analyzed for cytokine flow cytometry method. We evaluated Th1 and Th2 cytokines.
six weeks
Secondary Outcomes (5)
Distance walked during the 6-minute walk
6 weeks
Changes in lung function
Before and after 6 weeks of intervention
Days free of asthma
After six weeks
Respiratory pressures maxima
Before and after 6 weeks
Analysis of cytokines
Before and after 6 weeks
Study Arms (2)
aerobic exercise
EXPERIMENTALThe 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.
control
PLACEBO COMPARATORInvestigators 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- mental deficit.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Integral Medicine Institute Professor. Fernando Figueira-IMIP
Recife, Pernambuco, 50070550, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Livia B Andrade, PhD student
Professor of Pediatric Physical Therapy Specialization of integral medicine institute Prof. Fernando Figueira
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD Student
Study Record Dates
First Submitted
May 13, 2013
First Posted
August 12, 2013
Study Start
August 1, 2011
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
August 12, 2013
Record last verified: 2013-08