NCT01920529

Brief Summary

Regular aerobic physical activity in short-term moderate asthma and severe:

  • Reduce the levels of inflammatory mediators
  • Improves functional capacity
  • Improves Quality of Life
  • Improved lung function
  • Reduces the sensation of dyspnea
  • Improves symptoms scores and medication use

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Aug 2011

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

Study Start

First participant enrolled

August 1, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 12, 2013

Completed
Last Updated

August 12, 2013

Status Verified

August 1, 2013

Enrollment Period

1.6 years

First QC Date

May 13, 2013

Last Update Submit

August 8, 2013

Conditions

Keywords

asthma, aerobic exercise, child, cytokines

Outcome Measures

Primary Outcomes (1)

  • Inflammatory mediators by analyzing cytokines by flow cytometry

    Was carried collection of peripheral blood cells separated and analyzed for cytokine flow cytometry method. We evaluated Th1 and Th2 cytokines.

    six weeks

Secondary Outcomes (5)

  • Distance walked during the 6-minute walk

    6 weeks

  • Changes in lung function

    Before and after 6 weeks of intervention

  • Days free of asthma

    After six weeks

  • Respiratory pressures maxima

    Before and after 6 weeks

  • Analysis of cytokines

    Before and after 6 weeks

Study Arms (2)

aerobic exercise

EXPERIMENTAL

The study will consist of two groups: Group Comparison (GC) will be submitted to two evaluations at the beginning of a week and end of 6 weeks, without receiving any kind of physical training intervention. Group Training (GT) will undergo two assessments at the beginning of the end of the 1st and 6th week, however will be submitted to aerobic training for six weeks. Supervised aerobic training will be held three times a week for six weeks,treadmill in four consecutive steps each (05 minutes stretching, 05 minutes heating, 20 training minutes (1 st and 2 nd week) and 30 minutes (3 rd to 6 weeks) and cool down 05 minutes). The exercise intensity will be maintained through a desired percentage of heart rate for training (x%) from 70% to 80%, obtaining then the optimal heart rate training.

Other: aerobic exercise

control

PLACEBO COMPARATOR

Investigators evaluated the distance walked during the 6-minute walk test and recorded variables such as heart rate, respiratory frequency, pulse oxygen saturation and a scale of perceived exertion (Borg) in the moments before and after the test. There was only evaluation without intervention.

Other: aerobic exercise

Interventions

Performed aerobic exercise on a treadmill with cardiac predetermined frequency within 6 weeks and frequency of three times per week. All patients were monitored during training.

Also known as: physical exercise, physical training
aerobic exercisecontrol

Eligibility Criteria

Age8 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age greater than eight and less than nineteen years
  • Diagnosis of moderate to severe persistent asthma according to criteria of GINA
  • forced expiratory volume in one minute (FEV1) below 80% of predicts
  • Initiation of treatment with inhaled corticosteroids for at least eight weeks before the start of collection.

You may not qualify if:

  • associated disease that limits physical activity, such as neuromuscular disease, congenital or acquired, severe cor pulmonate, severe congenital malformation
  • associated with chronic lung disease (cystic fibrosis, bronchiectasis, bronchopulmonary dysplasia, interstitial lung diseases
  • significant cognitive deficit, which makes the participant to respond adequately to the questionnaire and / or failure to meet the commands
  • mental deficit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Integral Medicine Institute Professor. Fernando Figueira-IMIP

Recife, Pernambuco, 50070550, Brazil

Location

MeSH Terms

Conditions

Asthma

Interventions

Exercise

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Livia B Andrade, PhD student

    Professor of Pediatric Physical Therapy Specialization of integral medicine institute Prof. Fernando Figueira

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 13, 2013

First Posted

August 12, 2013

Study Start

August 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

August 12, 2013

Record last verified: 2013-08

Locations