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Exercise Training in Asthma Children

Effects of Exercise Training on Markers of Lung Inflammation and Clinical Crontrol in Asthma Children

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01438294
Enrollment
36
Registered
2011-09-22
Start date
2011-11-30
Completion date
2013-11-30
Last updated
2014-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma, childhood, exercise

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.

Interventions

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).

Sponsors

University of Nove de Julho
CollaboratorOTHER
Hospital Sirio-Libanes
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
5 Years to 11 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Exhaled Nitric Oxide (FeNO) LevelThe 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 ®.

Secondary

MeasureTime frameDescription
Treadmil Test (Bruce Protocol)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.
Body Compositionbaseline 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).
Pulmonary Functionbaseline 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.

Other

MeasureTime frameDescription
Asthma Control Questionnaire (ACQ6) - Clinical Control of Diseaseclinical 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).
Energy Expenditurebaseline 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.

Countries

Brazil

Participant flow

Recruitment details

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.

Pre-assignment details

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).

Participants by arm

ArmCount
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).
13
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).
13
Total26

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up37

Baseline characteristics

CharacteristicVideo GameAerobic ExerciseTotal
ACQ61.71 units on a scale1.16 units on a scale1.62 units on a scale
Age, Categorical
<=18 years
13 Participants13 Participants26 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous7.5 years
STANDARD_DEVIATION 1.9
8.0 years
STANDARD_DEVIATION 2
7.61 years
STANDARD_DEVIATION 2.02
FeNO35.5 ppb
STANDARD_DEVIATION 19.7
31.7 ppb
STANDARD_DEVIATION 15.73
33.2 ppb
STANDARD_DEVIATION 18.4
Region of Enrollment
Brazil
13 participants13 participants26 participants
Sex: Female, Male
Female
7 Participants7 Participants14 Participants
Sex: Female, Male
Male
6 Participants6 Participants12 Participants
Walked distance561.6 meters
STANDARD_DEVIATION 126.9
607.6 meters
STANDARD_DEVIATION 148.5
580 meters
STANDARD_DEVIATION 132.4

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 160 / 20
serious
Total, serious adverse events
0 / 160 / 20

Outcome results

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 ®.

Time frame: The FeNO level was performed in week 8

ArmMeasureValue (MEAN)Dispersion
Aerobic ExerciseExhaled Nitric Oxide (FeNO) Level29.3 ppbStandard Deviation 21.5
Video GameExhaled Nitric Oxide (FeNO) Level23.3 ppbStandard Deviation 10.9
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).

Time frame: 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.

Time frame: baseline and after 8 weeks

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.

Time frame: 8 week distance walked on treadmill test

ArmMeasureValue (MEAN)Dispersion
Aerobic ExerciseTreadmil Test (Bruce Protocol)895.8 metersStandard Deviation 143.4
Video GameTreadmil Test (Bruce Protocol)703.3 metersStandard Deviation 148.3
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).

Time frame: clinical control week 8

ArmMeasureValue (MEDIAN)
Aerobic ExerciseAsthma Control Questionnaire (ACQ6) - Clinical Control of Disease0.25 units on a scale
Video GameAsthma Control Questionnaire (ACQ6) - Clinical Control of Disease0.25 units on a scale
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.

Time frame: baseline and during all training sessions 8 weeks

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026