Trial Outcomes & Findings for Exercise Training in Asthma Children (NCT NCT01438294)
NCT ID: NCT01438294
Last Updated: 2014-10-10
Results Overview
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 ®.
COMPLETED
NA
36 participants
The FeNO level was performed in week 8
2014-10-10
Participant Flow
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.
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).
Participant milestones
| Measure |
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).
|
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).
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|---|---|---|
|
Overall Study
STARTED
|
16
|
20
|
|
Overall Study
COMPLETED
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
3
|
7
|
Reasons for withdrawal
| Measure |
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).
|
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).
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|---|---|---|
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Overall Study
Lost to Follow-up
|
3
|
7
|
Baseline Characteristics
Exercise Training in Asthma Children
Baseline characteristics by cohort
| Measure |
Aerobic Exercise
n=13 Participants
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).
|
Video Game
n=13 Participants
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).
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.0 years
STANDARD_DEVIATION 2.0 • n=5 Participants
|
7.5 years
STANDARD_DEVIATION 1.9 • n=7 Participants
|
7.61 years
STANDARD_DEVIATION 2.02 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
ACQ6
|
1.16 units on a scale
n=5 Participants
|
1.71 units on a scale
n=7 Participants
|
1.62 units on a scale
n=5 Participants
|
|
FeNO
|
31.7 ppb
STANDARD_DEVIATION 15.73 • n=5 Participants
|
35.5 ppb
STANDARD_DEVIATION 19.7 • n=7 Participants
|
33.2 ppb
STANDARD_DEVIATION 18.4 • n=5 Participants
|
|
Walked distance
|
607.6 meters
STANDARD_DEVIATION 148.5 • n=5 Participants
|
561.6 meters
STANDARD_DEVIATION 126.9 • n=7 Participants
|
580 meters
STANDARD_DEVIATION 132.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: The FeNO level was performed in week 8The 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 ®.
Outcome measures
| Measure |
Aerobic Exercise
n=13 Participants
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).
|
Video Game
n=13 Participants
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).
|
|---|---|---|
|
Exhaled Nitric Oxide (FeNO) Level
|
29.3 ppb
Standard Deviation 21.5
|
23.3 ppb
Standard Deviation 10.9
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SECONDARY outcome
Timeframe: 8 week distance walked on treadmill testA 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.
Outcome measures
| Measure |
Aerobic Exercise
n=13 Participants
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).
|
Video Game
n=13 Participants
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).
|
|---|---|---|
|
Treadmil Test (Bruce Protocol)
|
895.8 meters
Standard Deviation 143.4
|
703.3 meters
Standard Deviation 148.3
|
SECONDARY outcome
Timeframe: baseline and after 8 weeksAll 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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline and after 8 weekswas 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: clinical control week 8Asthma 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).
Outcome measures
| Measure |
Aerobic Exercise
n=13 Participants
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).
|
Video Game
n=13 Participants
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).
|
|---|---|---|
|
Asthma Control Questionnaire (ACQ6) - Clinical Control of Disease
|
0.25 units on a scale
Interval 0.08 to 0.5
|
0.25 units on a scale
Interval 0.0 to 0.58
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline and during all training sessions 8 weeksWas 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.
Outcome measures
Outcome data not reported
Adverse Events
Aerobic Exercise
Video Game
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Evelim Leal de Freitas Dantas Gomes, PhD PT
Universidade Nove de Julho
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60