Impact of Aerobic Exercise on Asthma Morbidity
Ex-Asthma
1 other identifier
interventional
66
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 asthma
Started Jan 2010
Longer than P75 for phase_3 asthma
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2009
CompletedFirst Posted
Study publicly available on registry
August 6, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedFebruary 12, 2018
June 1, 2016
3.5 years
August 4, 2009
February 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Asthma control Questionnaire (Juniper)
Within 1 week of completion of the intervention (i.e., after 12 weeks)
Secondary Outcomes (3)
Asthma quality of life questionnaire (Juniper)
Within 1 week of completion of the intervention (i.e., after 12 weeks)
Asthma control test
Within 1 week of completion of the intervention (i.e., after 12 weeks)
Inflammatory markers
Within 1 week of completion of the intervention (i.e., after 12 weeks)
Study Arms (2)
Aerobic exercise
EXPERIMENTAL12 weeks of supervised aerobic exercise and standard care
Usual care
PLACEBO COMPARATOR12 weeks of standard care
Interventions
12 weeks of supervised exercise, 3 x week, 1 hour sessions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Montreal Chest Institute
Montreal, Quebec, H2X 2P4, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, H4J 1C5, Canada
Related Publications (1)
Bacon SL, Lavoie KL, Bourbeau J, Ernst P, Maghni K, Gautrin D, Labrecque M, Pepin V, Pedersen BK. The effects of a multisite aerobic exercise intervention on asthma morbidity in sedentary adults with asthma: the Ex-asthma study randomised controlled trial protocol. BMJ Open. 2013 Jun 20;3(6):e003177. doi: 10.1136/bmjopen-2013-003177.
PMID: 23794569DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Simon L Bacon, PhD
Hopital du Sacre-Coeur de Montreal / Concordia University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Researcher
Study Record Dates
First Submitted
August 4, 2009
First Posted
August 6, 2009
Study Start
January 1, 2010
Primary Completion
July 1, 2013
Study Completion
August 1, 2014
Last Updated
February 12, 2018
Record last verified: 2016-06