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OpenTrials
Completed

NCT Number: NCT00989365

Effect of Aerobic Training on Asthmatic Patients

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

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Key information

Conditions

Anxiety Airway Inflammation Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Motor Activity

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Hospital, School of Medicine, University of São Paulo

São Paulo, 05403-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 20-50 years old
  • moderate and severe asthma

Exclusion criteria

  • other pulmonary or cardiovascular disease

Treatment and study plan

Aerobic training

Other

Treadmill training

Other names: Exercise conditioning

Primary outcomes

  1. psychosocial morbidity and airway inflammation

    Time frame: 3 months

Secondary outcomes

  1. autonomic modulation, aerobic capacity, pulmonary function

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Fundação de Amparo à Pesquisa do Estado de São Paulo
  • Laboratório de Investigação Médica

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Oct 5, 2009
Registry last updated
Oct 5, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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