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| Name | Class |
|---|---|
| University of Nove de Julho | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aerobic exercise | Active Comparator | 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. |
|
| Video game | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Video game group | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Evelim Leal F DantasGomes, Master | University of Nove de Julho | Principal Investigator |
| Dirceu Costa, PhD | University of Nove de Julho | Study Chair |
| Luciana Maria M Sampaio, PhD | University of Nove de Julho | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Nove de Julho | São Paulo | São Paulo | 05001-972 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26301706 | Derived | 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. |
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Ten children (7 VGG/3 TG) withdrew from the study: 4 due to changes in the school schedule, 3 abandoned without explanation, 2 due to difficulties in the parents schedule and 1 that moved to another city. Twenty-six patients completed the study (13VGG/13TG).
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Aerobic Exercise | Aerobic exercise group: 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). |
| FG001 | Video Game | The game "Reflex Ridge" of Kinect Adventure (XBOX 360 KinectTM, Microsoft, USA) was used for training. A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, children played video game, each session lasted 30 minutes and was performed in 10 rounds each one lasting 3 minutes with a 30-second rest interval between rounds. The video game intensity was increased with each round, requiring the child to perform a greater number of jumps, squats, lateral movements and arm movements. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM , USA). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Aerobic exercise group: 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 ®. | Mean | Standard Deviation | ppb | The FeNO level was performed in week 8 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aerobic Exercise | Aerobic exercise group: 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Evelim Leal de Freitas Dantas Gomes, PhD PT | Universidade Nove de Julho | 5511976333349 | evelimfreitas@hotmail.com |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Aerobic exercise group | Other | 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). |
|
|
| 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). | 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. | baseline and after 8 weeks |
| 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. | baseline and during all training sessions 8 weeks |
| BG001 | 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). 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). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ACQ6 | Median | Inter-Quartile Range | units on a scale |
|
| FeNO | Mean | Standard Deviation | ppb |
|
| Walked distance | Mean | Standard Deviation | meters |
|
| OG001 | Video Game | The game "Reflex Ridge" of Kinect Adventure (XBOX 360 KinectTM, Microsoft, USA) was used for training. A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, children played video game, each session lasted 30 minutes and was performed in 10 rounds each one lasting 3 minutes with a 30-second rest interval between rounds. The video game intensity was increased with each round, requiring the child to perform a greater number of jumps, squats, lateral movements and arm movements. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM , USA). |
|
|
| Secondary | 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. | Mean | Standard Deviation | meters | 8 week distance walked on treadmill test |
|
|
|
| Secondary | 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). | baseline and after 8 weeks |
| Secondary | 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. | baseline and after 8 weeks |
| Other Pre-specified | 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). | Median | Inter-Quartile Range | units on a scale | clinical control week 8 |
|
|
|
| Other Pre-specified | 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. | baseline and during all training sessions 8 weeks |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Video Game | The game "Reflex Ridge" of Kinect Adventure (XBOX 360 KinectTM, Microsoft, USA) was used for training. A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, children played video game, each session lasted 30 minutes and was performed in 10 rounds each one lasting 3 minutes with a 30-second rest interval between rounds. The video game intensity was increased with each round, requiring the child to perform a greater number of jumps, squats, lateral movements and arm movements. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM , USA). | 0 | 20 | 0 | 20 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D001519 | Behavior |