An interventional study of Video game group and Aerobic exercise group in Asthma, sponsored by Hospital Sirio-Libanes. Completed at 1 site in Brazil. Open to participants aged 5 Years to 11 Years. Per ClinicalTrials.gov, last updated 2014-10-10.
Sponsored by Hospital Sirio-Libanes · Not applicable, Interventional, and Supportive care
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.
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 36 is below the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →Hospital Sirio-Libanes is the lead sponsor of 44 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Other: Aerobic exercise group
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).
Other: Video game group
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).
Also known as: treadmill training
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 ®.
Time frame: The FeNO level was performed in week 8
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.
Time frame: 8 week distance walked on treadmill test
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).
Time frame: baseline and after 8 weeks
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.
Time frame: baseline and after 8 weeks
Asthma Control Questionnaire (ACQ6) - Clinical Control of Disease
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
Energy Expenditure
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
Children were randomly allocated to either video game (VGG) or treadmill training (TG) group. 2 sealed envelopes were prepared for each participant, each envelope corresponded to one of the study groups and the envelope was drawn for each participant by the researcher after the baseline measurements have been performed.
| Milestone | Aerobic Exercise | Video Game |
|---|---|---|
| Started | 16 | 20 |
| Completed | 13 | 13 |
| Not completed | 3 | 7 |
| Withdrew: Lost to follow-up | 3 | 7 |
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 ®.
| ppb | Aerobic Exercise | Video Game |
|---|---|---|
| Exhaled Nitric Oxide (FeNO) Level | 29.3 ± 21.5 | 23.3 ± 10.9 |
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.
| meters | Aerobic Exercise | Video Game |
|---|---|---|
| Treadmil Test (Bruce Protocol) | 895.8 ± 143.4 | 703.3 ± 148.3 |
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).
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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).
| units on a scale | Aerobic Exercise | Video Game |
|---|---|---|
| Asthma Control Questionnaire (ACQ6) - Clinical Control of Disease | 0.25 (0.08 to 0.50) | 0.25 (0 to 0.58) |
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.
No measurements were reported for this outcome.
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Aerobic Exercise | — | 0/16 (0%) | 0/16 (0%) |
| Video Game | — | 0/20 (0%) | 0/20 (0%) |
| Age, Continuous(years) | Aerobic Exercise | Video Game | Total |
|---|---|---|---|
| Mean | 8.0 ± 2.0 | 7.5 ± 1.9 | 7.61 ± 2.02 |
| Age, Categorical(Participants) | Aerobic Exercise | Video Game | Total |
|---|---|---|---|
| <=18 years | 13 | 13 | 26 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Aerobic Exercise | Video Game | Total |
|---|---|---|---|
| Female | 7 | 7 | 14 |
| Male | 6 | 6 | 12 |
| Region of Enrollment(participants) | Aerobic Exercise | Video Game | Total |
|---|---|---|---|
| Brazil | 13 | 13 | 26 |
| ACQ6(units on a scale) | Aerobic Exercise | Video Game | Total |
|---|---|---|---|
| Median | 1.16 (0.58 to 1.66) | 1.71 (0.83 to 2.66) | 1.62 (0.58 to 2.66) |
| FeNO(ppb) | Aerobic Exercise | Video Game | Total |
|---|---|---|---|
| Mean | 31.7 ± 15.73 | 35.5 ± 19.7 | 33.2 ± 18.4 |
| Walked distance(meters) | Aerobic Exercise | Video Game | Total |
|---|---|---|---|
| Mean | 607.6 ± 148.5 | 561.6 ± 126.9 | 580 ± 132.4 |
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