Exercise Training in Asthma Children
Effects of Exercise Training on Markers of Lung Inflammation and Clinical Crontrol in Asthma Children
1 other identifier
interventional
36
1 country
1
Brief Summary
The purpose of this study is to assess the effects of a physical training program with active video game in inflammatory markers, quality of life variables , clinical control and physical and functional respiratory assessment of asthmatic children from 5 to 11 years.
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 Nov 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
First Submitted
Initial submission to the registry
September 18, 2011
CompletedFirst Posted
Study publicly available on registry
September 22, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedResults Posted
Study results publicly available
October 10, 2014
CompletedOctober 10, 2014
October 1, 2014
1.5 years
September 18, 2011
July 5, 2014
October 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Exhaled Nitric Oxide (FeNO) Level
The measurement of exhaled FeNO level is performed by several commercially available devices, however the equipment NIOX ® (Aerocrine, Sweden) analyzer is the only FDA-approved and Anvisa (Food and Drug Administration) for clinical monitoring of asthma. The measure will be performed before and after the training program of exercise, or pulmonary rehabilitation, by means of portable equipment NIOX MINO ®.
The FeNO level was performed in week 8
Secondary Outcomes (3)
Treadmil Test (Bruce Protocol)
8 week distance walked on treadmill test
Body Composition
baseline and after 8 weeks
Pulmonary Function
baseline and after 8 weeks
Other Outcomes (2)
Asthma Control Questionnaire (ACQ6) - Clinical Control of Disease
clinical control week 8
Energy Expenditure
baseline and during all training sessions 8 weeks
Study Arms (2)
Aerobic exercise
ACTIVE COMPARATORThe aerobic training will be done on the treadmill with heart monitors with intensity required to achieve 70% of maximum heart rate reached the maximum test for thirty minutes.
Video game
EXPERIMENTALThe training with video game will be done with heart rate monitors with intensity required to achieve 70% of maximum heart rate reached the maximum test for thirty minutes.Will be used Kinect games ( reflex ridge- Adventure).
Interventions
The training with video game will be done with heart rate monitors with intensity required to achieve 70% of maximum heart rate reached the maximum test for thirty minutes.Will be used Kinect games ( adventure- reflex ridge).
A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, exercise training was performed during 30 minutes beginning at 70% of the maximum effort determined in the maximal exercise testing. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM, USA). There was progression in the training intensity throughout the study: if the patient maintained 2 consecutive exercise sessions without symptoms, exercise intensity was increased by 5% of cardiac frequency by using either treadmill speed or grade as previously described (Mendes et al.2011).
Eligibility Criteria
You may qualify if:
- Ages 5 to 11 years;
- Having a diagnosis of asthma, according to the criteria of the National Heart, Lung, and Blood Institute, and
- Not be included in any program of regular physical activity.
You may not qualify if:
- Having received aminophylline and theophylline or oral corticosteroids in the last 30 days;
- Respiratory infection have shown over the past two months;
- Have done with inhaled bronchodilator in less than 12 hours before the assessment;
- Inability to perform any of the tests;
- Have heart disease of inflammatory origin, congenital or ischemic;
- Being in the presence of any infectious process with fever and
- Do not agree to the terms of consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Sirio-Libaneslead
- University of Nove de Julhocollaborator
Study Sites (1)
University Nove de Julho
São Paulo, São Paulo, 05001-972, Brazil
Related Publications (1)
Gomes EL, Carvalho CR, Peixoto-Souza FS, Teixeira-Carvalho EF, Mendonca JF, Stirbulov R, Sampaio LM, Costa D. Active Video Game Exercise Training Improves the Clinical Control of Asthma in Children: Randomized Controlled Trial. PLoS One. 2015 Aug 24;10(8):e0135433. doi: 10.1371/journal.pone.0135433. eCollection 2015.
PMID: 26301706DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Evelim Leal de Freitas Dantas Gomes, PhD PT
- Organization
- Universidade Nove de Julho
Study Officials
- PRINCIPAL INVESTIGATOR
Evelim Leal F DantasGomes, Master
University of Nove de Julho
- STUDY CHAIR
Dirceu Costa, PhD
University of Nove de Julho
- STUDY DIRECTOR
Luciana Maria M Sampaio, PhD
University of Nove de Julho
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD in science Rehabilitation
Study Record Dates
First Submitted
September 18, 2011
First Posted
September 22, 2011
Study Start
November 1, 2011
Primary Completion
May 1, 2013
Study Completion
November 1, 2013
Last Updated
October 10, 2014
Results First Posted
October 10, 2014
Record last verified: 2014-10