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Exercise Training in Asthma Children

This study has been completed.
Sponsor:
Collaborator:
University of Nove de Julho
Information provided by (Responsible Party):
Evelim Leal de Freitas Dantas Gomes, PhD, Hospital Sirio-Libanes
ClinicalTrials.gov Identifier:
NCT01438294
First received: September 18, 2011
Last updated: October 5, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Asthma
Other: Video game group
Other: Aerobic exercise group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effects of Exercise Training on Markers of Lung Inflammation and Clinical Crontrol in Asthma Children

Resource links provided by NLM:


Further study details as provided by Hospital Sirio-Libanes:

Primary Outcome Measures:
  • Exhaled Nitric Oxide (FeNO) Level [ Time Frame: The FeNO level was performed in week 8 ] [ Designated as safety issue: Yes ]

    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 ®.



Secondary Outcome Measures:
  • Treadmil Test (Bruce Protocol) [ Time Frame: 8 week distance walked on treadmill test ] [ Designated as safety issue: Yes ]

    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.


  • Body Composition [ Time Frame: baseline and after 8 weeks ] [ Designated as safety issue: Yes ]
    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).

  • Pulmonary Function [ Time Frame: baseline and after 8 weeks ] [ Designated as safety issue: Yes ]
    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.


Other Outcome Measures:
  • Asthma Control Questionnaire (ACQ6) - Clinical Control of Disease [ Time Frame: clinical control week 8 ] [ Designated as safety issue: Yes ]

    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).


  • Energy Expenditure [ Time Frame: baseline and during all training sessions 8 weeks ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 36
Study Start Date: November 2011
Study Completion Date: November 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Other: 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).
Other Name: treadmill training
Experimental: 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).
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).

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.

  Eligibility

Ages Eligible for Study:   5 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01438294

Locations
Brazil
University Nove de Julho
São Paulo, SP, Brazil, 05001-972
Sponsors and Collaborators
Hospital Sirio-Libanes
University of Nove de Julho
Investigators
Principal Investigator: Evelim Leal F DantasGomes, Master University of Nove de Julho
Study Chair: Dirceu Costa, PhD University of Nove de Julho
Study Director: Luciana Maria M Sampaio, PhD University of Nove de Julho
  More Information

No publications provided

Responsible Party: Evelim Leal de Freitas Dantas Gomes, PhD, PhD in science Rehabilitation, Hospital Sirio-Libanes
ClinicalTrials.gov Identifier: NCT01438294     History of Changes
Other Study ID Numbers: ASMAPED
Study First Received: September 18, 2011
Results First Received: July 5, 2014
Last Updated: October 5, 2014
Health Authority: Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency

Keywords provided by Hospital Sirio-Libanes:
Asthma
childhood
exercise

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 25, 2014