AsthmaNCT01438294
Exercise Training in Asthma Children
A study testing Video game group and Aerobic exercise group in people with Asthma, run by Hospital Sirio-Libanes at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 11 years
- Conditions the study is for
- Asthma
- What is being tested?
- Video game group and Aerobic exercise group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2011to Nov 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Exercise Training on Markers of Lung Inflammation and Clinical Crontrol in Asthma Children
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Video game group, Aerobic exercise group
- Keywords
- Asthma, childhood, exercise
- Medical subject headings
- Asthma, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video game groupOther
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).
Aerobic exercise groupOther
Also called treadmill training
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Aerobic exercise group |
| 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). Receives: Other: Video game group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 ®.
Measured: The FeNO level was performed in week 8
Secondary outcomes (3)
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.
Measured: 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).
Measured: 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.
Measured: baseline and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2011 (estimated)
- Study startNov 2011
- Primary completionMay 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Sirio-Libanes
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nove de Julho
- Responsible party
- Principal investigator, Evelim Leal de Freitas Dantas Gomes, PhD, Hospital Sirio-Libanes
- Investigators
- Evelim Leal F DantasGomes, Master, Principal investigator, University of Nove de JulhoDirceu Costa, PhD, Study chair, University of Nove de JulhoLuciana Maria M Sampaio, PhD, Study director, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01438294
- Sponsor's protocol ID
- ASMAPED
- Status last verified
- Oct 2014
- First submitted
- 18 Sep 2011
- Last updated
- 10 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 26301706
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise Training on Markers of Lung Inflammation and Clinical Crontrol in Asthma Children
- ClinicalTrials.gov ID
- NCT01438294
- Acronym / sponsor ID
- ASMAPED
- Conditions
- Asthma
- Keywords
- Asthma, childhood, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hospital Sirio-LibanesUniversity, hospital or other
- Collaborators
- University of Nove de Julho
- Study start
- Nov 2011
- Primary completion
- May 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 22 Sep 2011 (estimated)
- Results
- Posted 10 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise | Active comparator | Other: Aerobic exercise groupThe 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 | Other: Video game groupThe 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). |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video game groupThe 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). | Other | Video game |
| Aerobic exercise groupAlso: treadmill trainingA 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 | Aerobic exercise |
Primary outcome
Exhaled Nitric Oxide (FeNO) Level
Time frame: The FeNO level was performed in week 8
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 ®.
3 secondary outcomes
Treadmil Test (Bruce Protocol)
Time frame: 8 week distance walked on treadmill test
Body Composition
Time frame: baseline and after 8 weeks
Pulmonary Function
Time frame: baseline and after 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26301706Gomes 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evelim Leal F DantasGomes, Master principal investigator
University of Nove de Julho
Dirceu Costa, PhD study chair
University of Nove de Julho
Luciana Maria M Sampaio, PhD study director
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video game group and Aerobic exercise group in people with Asthma, run by Hospital Sirio-Libanes at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exhaled Nitric Oxide (FeNO) Level (time frame: The FeNO level was performed in week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01438294, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2014.