- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01438294
Exercise Training in Asthma Children
Effects of Exercise Training on Markers of Lung Inflammation and Clinical Crontrol in Asthma Children
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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SP
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São Paulo, SP, Brazil, 05001-972
- University Nove de Julho
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Aerobic exercise
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.
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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).
Other Names:
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Experimental: Video game
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).
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exhaled Nitric Oxide (FeNO) Level
Time Frame: The FeNO level was performed in week 8
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treadmil Test (Bruce Protocol)
Time Frame: 8 week distance walked on treadmill test
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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. |
8 week distance walked on treadmill test
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Body Composition
Time Frame: baseline and after 8 weeks
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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).
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baseline and after 8 weeks
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Pulmonary Function
Time Frame: baseline and after 8 weeks
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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.
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baseline and after 8 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Asthma Control Questionnaire (ACQ6) - Clinical Control of Disease
Time Frame: clinical control week 8
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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). |
clinical control week 8
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Energy Expenditure
Time Frame: baseline and during all training sessions 8 weeks
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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.
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baseline and during all training sessions 8 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- 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
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ASMAPED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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