Exercise Training in Asthma Children
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Video game group
Aerobic exercise group
Sponsored by

About this trial
This is an interventional supportive care trial for Asthma focused on measuring Asthma, childhood, exercise
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- University Nove de Julho
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Aerobic exercise
Video game
Arm Description
The 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.
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 ( reflex ridge- Adventure).
Outcomes
Primary Outcome Measures
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 ®.
Secondary Outcome Measures
Treadmil Test (Bruce Protocol)
A maximal exercise testing was performed in a treadmill using Bruce protocol that has been used to provide information on exercise capacity, physiopathological characteristics during effort, the efficacy of medications and the potential risk for diseases ( Zijp et al. 2010). The test was interrupted when the child reported maximal fatigue or reached the maximum heart rate around 200bpm (Peyer et al. 2011). During the test, blood pressure and peripheral oxygen saturation were quantified and an electrocardiogram was performed. The Borg scale was used to quantify for the sensation of shortness of breath during effort and at rest (Lamb 1995).
Change from baseline in the distance walked on treadmill test will be consider as outcome measure.
Body Composition
All participants were evaluated individually, always during the afternoon to avoid circadian changes. Height, weight and abdominal circumference were determined. Tetrapolar bioimpedance was measured using the Biodynamics™ model 310 (Biodynamics Corporation Seattle WA, USA) by positioning the child in the supine position and electrodes in the extremity of the right upper and lower limbs (Goran et al.1993).
Pulmonary Function
was performed before and after the inhalation of 400μg of salbutamol (Easy One™, USA), and technical procedures were performed as recommended by ATS/ERS. Predicted normal values were those proposed by Polgar and Promadhat 1971 and a 12% and 200 mL increase in FEV1 from baseline were characterized as a positive response to the bronchodilator) in a climate-controlled room.
Full Information
NCT ID
NCT01438294
First Posted
September 18, 2011
Last Updated
October 5, 2014
Sponsor
Hospital Sirio-Libanes
Collaborators
University of Nove de Julho
1. Study Identification
Unique Protocol Identification Number
NCT01438294
Brief Title
Exercise Training in Asthma Children
Official Title
Effects of Exercise Training on Markers of Lung Inflammation and Clinical Crontrol in Asthma Children
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Sirio-Libanes
Collaborators
University of Nove de Julho
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The aim of the present study will be to determine whether an aerobic exercise using an active video game system improves asthma control, lung inflammation and functional capacity in children with moderate or severe asthma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, childhood, exercise
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aerobic exercise
Arm Type
Active Comparator
Arm Description
The 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.
Arm Title
Video game
Arm Type
Experimental
Arm Description
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 ( reflex ridge- Adventure).
Intervention Type
Other
Intervention Name(s)
Video game group
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Aerobic exercise group
Other Intervention Name(s)
treadmill training
Intervention Description
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).
Primary Outcome Measure Information:
Title
Exhaled Nitric Oxide (FeNO) Level
Description
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 ®.
Time Frame
The FeNO level was performed in week 8
Secondary Outcome Measure Information:
Title
Treadmil Test (Bruce Protocol)
Description
A maximal exercise testing was performed in a treadmill using Bruce protocol that has been used to provide information on exercise capacity, physiopathological characteristics during effort, the efficacy of medications and the potential risk for diseases ( Zijp et al. 2010). The test was interrupted when the child reported maximal fatigue or reached the maximum heart rate around 200bpm (Peyer et al. 2011). During the test, blood pressure and peripheral oxygen saturation were quantified and an electrocardiogram was performed. The Borg scale was used to quantify for the sensation of shortness of breath during effort and at rest (Lamb 1995).
Change from baseline in the distance walked on treadmill test will be consider as outcome measure.
Time Frame
8 week distance walked on treadmill test
Title
Body Composition
Description
All participants were evaluated individually, always during the afternoon to avoid circadian changes. Height, weight and abdominal circumference were determined. Tetrapolar bioimpedance was measured using the Biodynamics™ model 310 (Biodynamics Corporation Seattle WA, USA) by positioning the child in the supine position and electrodes in the extremity of the right upper and lower limbs (Goran et al.1993).
Time Frame
baseline and after 8 weeks
Title
Pulmonary Function
Description
was performed before and after the inhalation of 400μg of salbutamol (Easy One™, USA), and technical procedures were performed as recommended by ATS/ERS. Predicted normal values were those proposed by Polgar and Promadhat 1971 and a 12% and 200 mL increase in FEV1 from baseline were characterized as a positive response to the bronchodilator) in a climate-controlled room.
Time Frame
baseline and after 8 weeks
Other Pre-specified Outcome Measures:
Title
Asthma Control Questionnaire (ACQ6) - Clinical Control of Disease
Description
Asthma control questionnaire (ACQ) is a standardized toll to assess clinical control in asthmatic patients and consists of 7 questions, 5 related to asthma symptoms, one regarding the use of short- acting ß2 agonists as rescue medication, and one regarding FEV1 before bronchodilator in percent of predicted.
ACQ score is the average these items and ranges from 0 (completely controlled) to 6 (uncontrolled) obtained in a 7 days period. The total points is divided by six to provide the final score ( six questions with range 0 to 6 points, maximal 36 points divided by six maximal 6 and mimimal 0)
The cutoff point for controlled/uncontrolled asthma is 2 points. Patient was classified according ACQ scores into controlled (<0.75), partially controlled (0.75-1.5) and uncontrolled asthma (>1.5). A minimal clinical important difference is 0.5 on a 7-point scale (Juniper et al.2005, Leite et al. 2008 and Ko et al. 2012).
Time Frame
clinical control week 8
Title
Energy Expenditure
Description
Was measured using a biaxial accelerometer (SenseWearTM Pro activity monitor, USA) (Kuys et al. 2011). The equipment was always used on the upper right limb for the determination of skin temperature, galvanic skin response and movement. Energy expenditure was calculated in metabolic equivalents (METS) and calories per minute. The SenseWear arm bandTM was used during the exercise sessions as a comparative parameter of effort intensity in the VGG and TG. The energy expenditure at rest, medium and maximum effort was the average of all sessions of all children.
Time Frame
baseline and during all training sessions 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evelim Leal F DantasGomes, Master
Organizational Affiliation
University of Nove de Julho
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dirceu Costa, PhD
Organizational Affiliation
University of Nove de Julho
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Luciana Maria M Sampaio, PhD
Organizational Affiliation
University of Nove de Julho
Official's Role
Study Director
Facility Information:
Facility Name
University Nove de Julho
City
São Paulo
State/Province
SP
ZIP/Postal Code
05001-972
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
26301706
Citation
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.
Results Reference
derived
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Exercise Training in Asthma Children
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