Back to resultsEffect of Aerobic Training on Asthmatic Patients
Primary Purpose
Anxiety, Depression, Airway Inflammation
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Aerobic training
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety focused on measuring Aerobic Exercise, Exercise
Eligibility Criteria
Inclusion Criteria:
- 20-50 years old
- moderate and severe asthma
Exclusion Criteria:
- other pulmonary or cardiovascular disease
Sites / Locations
- Clinical Hospital, School of Medicine, University of São Paulo
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patient cousenling
Arm Description
Improve medicine use Self control asthma crisis Ambient hygiene
Outcomes
Primary Outcome Measures
psychosocial morbidity and airway inflammation
Secondary Outcome Measures
autonomic modulation, aerobic capacity, pulmonary function
Full Information
NCT ID
NCT00989365
First Posted
October 2, 2009
Last Updated
October 2, 2009
Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Laboratório de Investigação Médica
1. Study Identification
Unique Protocol Identification Number
NCT00989365
Brief Title
Effect of Aerobic Training on Asthmatic Patients
Official Title
Effect of Aerobic Training on Psychosocial Morbidity, Symptoms, Airway Inflammation and Autonomic Modulation in Asthmatic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Laboratório de Investigação Médica
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression, Airway Inflammation
Keywords
Aerobic Exercise, Exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient cousenling
Arm Type
Other
Arm Description
Improve medicine use Self control asthma crisis Ambient hygiene
Intervention Type
Other
Intervention Name(s)
Aerobic training
Other Intervention Name(s)
Exercise conditioning
Intervention Description
Treadmill training
Primary Outcome Measure Information:
Title
psychosocial morbidity and airway inflammation
Time Frame
3 months
Secondary Outcome Measure Information:
Title
autonomic modulation, aerobic capacity, pulmonary function
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
20-50 years old
moderate and severe asthma
Exclusion Criteria:
other pulmonary or cardiovascular disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Celso RF Carvalho, PhD
Organizational Affiliation
School of Medicine, University of São Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Clinical Hospital, School of Medicine, University of São Paulo
City
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
17805077
Citation
Fanelli A, Cabral AL, Neder JA, Martins MA, Carvalho CR. Exercise training on disease control and quality of life in asthmatic children. Med Sci Sports Exerc. 2007 Sep;39(9):1474-80. doi: 10.1249/mss.0b013e3180d099ad.
Results Reference
background
PubMed Identifier
20363839
Citation
Mendes FA, Goncalves RC, Nunes MP, Saraiva-Romanholo BM, Cukier A, Stelmach R, Jacob-Filho W, Martins MA, Carvalho CR. Effects of aerobic training on psychosocial morbidity and symptoms in patients with asthma: a randomized clinical trial. Chest. 2010 Aug;138(2):331-7. doi: 10.1378/chest.09-2389. Epub 2010 Apr 2.
Results Reference
derived
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Effect of Aerobic Training on Asthmatic Patients
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