Impact of Aerobic Exercise on Asthma Morbidity (Ex-Asthma)

This study is currently recruiting participants.
Verified October 2012 by Hopital du Sacre-Coeur de Montreal
Sponsor:
Collaborators:
McGill University Health Center
Jewish General Hospital
Information provided by (Responsible Party):
Simon Bacon, Hopital du Sacre-Coeur de Montreal
ClinicalTrials.gov Identifier:
NCT00953342
First received: August 4, 2009
Last updated: October 16, 2012
Last verified: October 2012

August 4, 2009
October 16, 2012
January 2010
June 2013   (final data collection date for primary outcome measure)
Asthma control Questionnaire (Juniper) [ Time Frame: Within 1 week of completion of the intervention (i.e., after 12 weeks) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00953342 on ClinicalTrials.gov Archive Site
  • Asthma quality of life questionnaire (Juniper) [ Time Frame: Within 1 week of completion of the intervention (i.e., after 12 weeks) ] [ Designated as safety issue: No ]
  • Asthma control test [ Time Frame: Within 1 week of completion of the intervention (i.e., after 12 weeks) ] [ Designated as safety issue: No ]
  • Inflammatory markers [ Time Frame: Within 1 week of completion of the intervention (i.e., after 12 weeks) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Impact of Aerobic Exercise on Asthma Morbidity
Impact of Aerobic Exercise on Asthma Morbidity

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.

Introduction: Asthma is a chronic respiratory disorder primarily driven by increased airway inflammation. It is one of the most prevalent chronic conditions affecting Canadians. It is the most common chronic illness affecting children and the fourth most common disorders affecting adults. In 2001, nearly 2.2 million (8.4%) Canadians were diagnosed as having asthma. More importantly, asthma is an escalating medical problem in Canada, e.g., between 1994 and 2001, there was a 40% increase in the number of Canadians with asthma. Not only is the prevalence of asthma increasing, but there has been a rapid rise in the morbidity and costs associated with asthma and its poor control. The WHO estimated that the global cost of caring for asthma exceeds that of AIDS/HIV and tuberculosis combined. Though recent guidelines have emphasized the importance of improving asthma control and quality of life, leading to huge amounts of resource being dedicated to this, more than 50% of adult patients with asthma remain poorly controlled. As current treatment strategies appear to be failing, it is important to target simple, cost effective interventions that are applicable for most patients with asthma and will increase overall levels of control and decrease asthma morbidity. There is evidence to suggest that aerobic exercise may improve asthma symptoms and control in children. In addition, there is evidence that exercise directly improves inflammatory and immune profiles in non-asthma patients, which may provide the mechanism by which exercise could improve asthma. However, there are no known studies that have systematically assessed the effects of aerobic exercise on asthma control, quality of life or immune function in adult asthma populations.

Objective: The primary objective of the current application is to assess the efficacy of aerobic exercise as an intervention to improve asthma control and quality of life in adult patients with asthma. The results of this study will provide data that will inform physicians and members of the Thoracic community about the benefits of exercise for asthma. The study will also assess potential inflammatory pathways by which exercise may elicit improvements in asthma morbidity. The results of this study should be available for the next Canadian Thoracic Society Canadian Adult Consensus Guidelines.

Methodology: The current proposal is for a study of aerobic exercise in sedentary patients with poorly controlled asthma. In addition to usual care, 52 patients will undertake supervised aerobic exercise. The exercise program will consist of 3 X 1hr sessions of supervised exercise per week for 12 weeks. The exercise routine, under medical supervision, will consist of 10 minutes of warm up exercises, 40 minutes of biking and/or walking (and eventually jogging), and 10 minutes of cool down exercises. These patients will be compared to a group of 52 patients who will follow their usual regimen, this group will be offered the exercise programme once they have completed the post assessments. For the primary outcomes (asthma control [Asthma Control Questionnaire], quality of life [Asthma Quality of Life Questionnaire]) and secondary outcomes (inflammatory profile) will be evaluated at baseline and after 12 weeks (the length of the treatment). To check the efficacy of the intervention both lung function, ambulatory peak flow, and exercise tolerance data will also be collected. Repeated measures analysis of covariance-type models with time (pre, post intervention) as the within subject factor, group (exercise, usual care) as the between factor, and sex, age, and asthma severity as the covariates will be used for the primary outcome variables. To assess the potential mechanistic role of inflammation on the exercise-asthma relationship a series of regression-like GLMs will be conducted.

It is hypothesized that: (1) The exercise intervention will result in clinically and statistically significant improvements in levels of asthma control and asthma quality of life; (2) The exercise intervention will result in clinically and statistically significant improvements in inflammatory profiles, with reductions in Th2 cytokines, and activation of inflammatory cells, and increases in Th1 cytokines; and (3) Changes in inflammatory profile will be directly linked to improvements in asthma measures.

We believe that the proposal will have great clinical significance for patient management. This project will be the first to systematically evaluate the benefits of exercise training on asthma control and quality of life in adult asthma patients. We anticipate that the results of this study will form the basis for new national and international guidelines and will provide an evidence-based background for physicians to prescribe aerobic exercise for patients with asthma.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Asthma
  • Behavioral: Aerobic exercise
    12 weeks of supervised exercise, 3 x week, 1 hour sessions
  • Behavioral: Usual care
    Standard medical care
  • Experimental: Aerobic exercise
    12 weeks of supervised aerobic exercise and standard care
    Intervention: Behavioral: Aerobic exercise
  • Placebo Comparator: Usual care
    12 weeks of standard care
    Intervention: Behavioral: Usual care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
104
June 2013
June 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Guillaume Lacoste, BSc 514-338-2222 ext 3364 g_lacoste_@hotmail.com
Contact: Chantal Daigneault, BSc 514-338-2222 ext 3364 chantal.daigneault@crhsc.rtss.qc.ca
Canada
 
NCT00953342
MOP93807
No
Simon Bacon, Hopital du Sacre-Coeur de Montreal
Hopital du Sacre-Coeur de Montreal
  • McGill University Health Center
  • Jewish General Hospital
Principal Investigator: Simon L Bacon, PhD Hopital du Sacre-Coeur de Montreal / Concordia University
Hopital du Sacre-Coeur de Montreal
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP