NCT03014154

Brief Summary

Asthma is a chronic inflammatory disease of the Airways of recurring character. The obstruction to the airflow carries the short-and long-term consequences that require prophylactic interventions and in emergency many times. The children due to immaturity of the respiratory system associated with the use of steroids suffer structural consequences, as for example, the physical deconditioning that intensifies the symptoms of the disease and affects negatively on the quality of life. Therefore, to set up a physical training program suitable for the paediatric population, using resources to increase adherence to the regular practice of exercises, can be the difference for the reduction of the number of exacerbations, the sensation of Dyspnea and the doses of medication, positively impacting the clinical picture of child asthmatic. The investigators conducted a randomized, blinded in order to evaluate the effects of training with active video game associated with resisted exercise the exercise in inflammatory and functional outcomes resisted in asthmatic children.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2015

Completed
12 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 9, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

December 5, 2017

Status Verified

December 1, 2017

Enrollment Period

3 months

First QC Date

October 13, 2015

Last Update Submit

December 3, 2017

Conditions

Keywords

video gamesasthmaphysical exercise

Outcome Measures

Primary Outcomes (1)

  • Measurement of the Fraction of exhaled nitric oxide (FENO)

    The fraction of exhaled nitric oxide (FENO) has been a feature used to complement the diagnosis of asthma in children and adults, in children are considered within normal values values up to 20 parts per billion (ppb). Patients with respiratory symptoms associated with FENO of 20ppb, which suggests the inflammation of the airways, may represent greater succession of seizures and non-control of the disease. The Fraction of exhaled nitric oxide will be measured by following the criteria of ATS, in the Mino NIOX ® equipment (Aerocrine). The evaluation of this variable will be performed prior to the therapeutic intervention and after 8 weeks in order to observe the level of airway inflammation after physical activity. An evaluation of this variable after 8 weeks of intervention aims to observe the level of inflammation of the airway and a physical activity.

    Change of Fraction of exhaled nitric oxide in 8 weeks at physical activity

Secondary Outcomes (1)

  • Measuring energy expenditure

    Change in ability to exercise 8 weeks of physical activity

Study Arms (2)

Video training Game

ACTIVE COMPARATOR

Patients were submitted prior to the treadmill warming the 2kmh during 1° minutes before each session. Then held 30 minutes of aerobic interval training with video game (10 rounds of 3 minutes with 30 seconds of rest between each), followed by 5 minutes of cool-down again on the mat. The game used for training was the "reflex Ridge" Kinect Adventure (Xbox-360). At a higher level, it is necessary for the child to perform a greater number of jumps, squats, lateral movements and arm movements. All the activity was monitored against FC and SpO2. To determine the intensity of physical activity energy expenditure assessments were made. In which four are for the pre and post intervention evaluation and sixteen training sessions.

Other: Training

Endurance muscle training

ACTIVE COMPARATOR

Patients were submitted prior to the treadmill warming the 2kmh during 1° minutes before each session. Then held 30 minutes of aerobic interval training with video game (10 rounds of 3 minutes with 30 seconds of rest between each) followed by 5 minutes of cool-down again on the mat.Then the children were subjected to low intensity to endurance muscle training with 3 sets of 15 repetitions to upper limbs diagonally primitive and flexion and extension to lower lumbs. All the activity was monitored against FC and SpO2.To determine the intensity of physical activity energy expenditure assessments were made. In which four are for the pre and post intervention evaluation and sixteen training sessions.

Other: Training

Interventions

Endurance muscle trainingVideo training Game

Eligibility Criteria

Age5 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients aged between 05 and 11 years
  • Both sexes
  • Diagnosis of asthma, according to the criteria of th e Global Initiative for Asthma (GINA)
  • Not be included in any program of regular physical activity
  • Not receiving Theophylline or aminophylline and oral steroid in the past 30 days
  • Not having presented with respiratory infection in the last 2 months
  • Have signed the term of free and clear in.

You may not qualify if:

  • Inability to understand or perform any one of the tests, due to physical and cognitive limitations
  • Intolerance the proposed activities
  • Be in in the presence of some infectious process with feverish and low adherence to the proposed Protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

laboratory of Functional Respiratory Assessment

São Paulo, 01156050, Brazil

Location

MeSH Terms

Conditions

Lung Diseases, ObstructiveAsthmaMotor Activity

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesBronchial DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 13, 2015

First Posted

January 9, 2017

Study Start

October 1, 2016

Primary Completion

January 1, 2017

Study Completion

November 1, 2017

Last Updated

December 5, 2017

Record last verified: 2017-12

Locations