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Effect of Aerobic Training on Asthmatic Patients

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ClinicalTrials.gov Identifier: NCT00989365
Recruitment Status : Completed
First Posted : October 5, 2009
Last Update Posted : October 5, 2009
Sponsor:
Collaborators:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Laboratório de Investigação Médica
Information provided by:
University of Sao Paulo General Hospital

Study Description
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Brief Summary:
The investigators hypothesize that aerobic training can reduce anxiety, depression and airway inflammation and those benefits may be related to changes in autonomic system.

Condition or disease Intervention/treatment Phase
Anxiety Depression Airway Inflammation Other: Aerobic training Not Applicable

Detailed Description:

One-hundred patients with moderate or severe persistent asthma, age ranging from 20 to 50 years-old recruited after a medical consultation. Asthma diagnosis based on GINA1 and patients were under medical treatment for at least 6-months and considered clinically stable (no crises and changes in medication for at least 30 days). Patients diagnosed with cardiovascular, pulmonary or musculoskeletal diseases impairing exercise training were excluded.

Experimental Design: Patients were studied between 2 medical consultation to avoid changes in medication during the study and patients were randomized (by drawing lots) into either Control or Training groups. CG was submitted to a 4-hour educational program and a breathing exercise program and TG was submitted to the same CG procedures plus an aerobic training program individually based on VO2max. Before and after the intervention, patients performed pulmonary function test and cardiopulmonary exercise testing and as well as fulfilled questionnaires to quantify asthma specific HRQL and anxiety and depression levels. Asthma daily symptoms were evaluated monthly.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Aerobic Training on Psychosocial Morbidity, Symptoms, Airway Inflammation and Autonomic Modulation in Asthmatic Patients
Study Start Date : January 2007
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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Arm Intervention/treatment
Patient cousenling
Improve medicine use Self control asthma crisis Ambient hygiene
 Other: Aerobic training
Treadmill training
Other Name: Exercise conditioning


Outcome Measures
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Primary Outcome Measures :
  1. psychosocial morbidity and airway inflammation [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. autonomic modulation, aerobic capacity, pulmonary function [ Time Frame: 3 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 20-50 years old
  • moderate and severe asthma

Exclusion Criteria:

  • other pulmonary or cardiovascular disease
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00989365


Locations
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Brazil
Clinical Hospital, School of Medicine, University of São Paulo
São Paulo, Brazil, 05403-000
Sponsors and Collaborators
University of Sao Paulo General Hospital
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Laboratório de Investigação Médica
Investigators
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Study Chair: Celso RF Carvalho, PhD School of Medicine, University of São Paulo
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Celso Ricardo Fernandes de Carvalho, School of Medicine, University of São Paulo
ClinicalTrials.gov Identifier: NCT00989365    
Other Study ID Numbers: Asthmatraining
First Posted: October 5, 2009    Key Record Dates
Last Update Posted: October 5, 2009
Last Verified: October 2009
Keywords provided by University of Sao Paulo General Hospital:
Aerobic Exercise
Exercise
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes