Effect of Aerobic Training on Asthmatic Patients

Depression Clinical Trial

Official title:

Effect of Aerobic Training on Psychosocial Morbidity, Symptoms, Airway Inflammation and Autonomic Modulation in Asthmatic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00989365
• Other study ID #: Asthmatraining
• Status: Completed
• Phase: N/A
• First received: October 2, 2009
• Last updated: October 2, 2009
• Start date: January 2007
• Est. completion date: September 2009

Study information

• Verified date: October 2009
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• 20-50 years old

• moderate and severe asthma

Exclusion Criteria:

• other pulmonary or cardiovascular disease

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Airway Inflammation
• Anxiety
• Depression
• Inflammation

Intervention

Other:
• Aerobic training
Treadmill training

Locations

Country	Name	City	State
Brazil	Clinical Hospital, School of Medicine, University of São Paulo	São Paulo

Sponsors (4)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo, Laboratório de Investigação Médica

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	psychosocial morbidity and airway inflammation		3 months	Yes
Secondary	autonomic modulation, aerobic capacity, pulmonary function		3 months	Yes