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Asthma | Impact of Aerobic Exercise on Asthma Morbidity

Asthma research study

What is the primary objective of this study?

Asthma is a chronic disorder of the airways primarily driven by increased airway inflammation, and is an escalating medical problem in Canada. For example, between 1994 and 2001 there was a 40% increase in the number of Canadians who had asthma. Not only is the prevalence of asthma increasing but there has been a rapid rise in the number of asthma events and costs associated with asthma and poor asthma control. It has been estimated that the global cost of caring for asthma exceeds that of AIDS/HIV and tuberculosis combined. These increases have occurred in spite of the development of clear asthma management guidelines. There is evidence to suggest that aerobic exercise, e.g., running or cycling, may improve asthma symptoms and control in children. However, there are currently no studies that have systematically assessed the effects of exercise on asthma control or symptoms in adults. The current proposed study will assess the effects of aerobic exercise in sedentary patients with poorly controlled asthma. In addition to usual medical care, 52 patients will participate in a supervised aerobic exercise program. The program will consist of 3 X 1hr sessions of supervised exercise per week for 12 weeks. Another 52 patients will only maintain usual medical care. The asthma control, quality of life, and inflammatory profile will be evaluated at baseline and following the 12 weeks of treatment. The investigators believe that: (1) The exercise intervention will significant improve asthma control and asthma quality of life; (2) The exercise intervention will result in significant improvements in inflammatory profiles; and (3) These changes in the inflammatory profile will be directly related to the improvements in asthma control and quality of life.

Who is eligible to participate?

Inclusion Criteria: - Physician diagnosed asthma (confirmed by medical record evidence of bronchodilator reversibility of 12% or a minimum of 180 cc or PC20 methacholine <= 16 mg/ml) - Sedentary (currently do less than 60 min of structured / planned physical activity per week) - Taking at least 250 mg fluticasone equivalent per day - On stable dose and regimen of asthma medications - Mild to moderate symptomatic asthma as defined by an Asthma Control Questionnaire score of 1.25 or greater. Exclusion Criteria: - Diagnosed co-morbid disease for which there are already established exercise guidelines i.e., cardiac disease or COPD - Any other medical condition that confers greater illness morbidity than asthma (e.g., active cancer) which will confirmed by physician review - FEV1 lower than 60% of predicted - Incapable of exercising - A BMI > 30 kg/m2 - Unable to speak or understand either French or English - <18 years of age - Patients who are currently pregnant or intend to become pregnant over the course of the study.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Asthma

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Behavioral:Aerobic exercise12 weeks of supervised exercise, 3 x week, 1 hour sessions

Behavioral:Usual careStandard medical care

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Aerobic exercise12 weeks of supervised aerobic exercise and standard care

Usual care12 weeks of standard care

Study Status

Completed

Start Date: January 2010

Completed Date: August 2014

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Asthma control Questionnaire (Juniper)

Secondary Outcome: Asthma quality of life questionnaire (Juniper)

Study sponsors, principal investigator, and references

Principal Investigator: Simon L Bacon, PhD

Lead Sponsor: Hopital du Sacre-Coeur de Montreal

Collaborator: McGill University Health Center

More information:https://clinicaltrials.gov/show/NCT00953342

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