Impact of Aerobic Exercise on Asthma Morbidity (Ex-Asthma)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Behavioral: Aerobic exercise Behavioral: Usual care |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Impact of Aerobic Exercise on Asthma Morbidity |
- Asthma control Questionnaire (Juniper) [ Time Frame: Within 1 week of completion of the intervention (i.e., after 12 weeks) ] [ Designated as safety issue: No ]
- 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 ]
| Estimated Enrollment: | 104 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Aerobic exercise
12 weeks of supervised aerobic exercise and standard care
|
Behavioral: Aerobic exercise
12 weeks of supervised exercise, 3 x week, 1 hour sessions
|
|
Placebo Comparator: Usual care
12 weeks of standard care
|
Behavioral: Usual care
Standard medical care
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| 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, Quebec | |
| Hopital du Sacre-Coeur de Montreal | Recruiting |
| Montreal, Quebec, Canada, H4J 1C5 | |
| Principal Investigator: Simon L Bacon, PhD | |
| Sub-Investigator: Kim L Lavoie, PhD | |
| Sub-Investigator: Manon Labrecque, MD | |
| Sub-Investigator: Karim Maghni, PhD | |
| Sub-Investigator: Veronique Pepin, PhD | |
| Sub-Investigator: Denyse Gautrin, PhD | |
| Montreal Chest Institute | Recruiting |
| Montreal, Quebec, Canada, H2X 2P4 | |
| Contact: Katrina Metz, BSc 514 934 1934 katrina.metz@mail.mcgill.ca | |
| Principal Investigator: Jean Bourbeau, MD | |
| Jewish General Hospital | Recruiting |
| Montreal, Quebec, Canada, H3T 1E2 | |
| Contact: Guillaume Lacoste, BSc 514 338 2222 ext 3364 g_lacoste_@hotmail.com | |
| Principal Investigator: Pierre Ernest, MD | |
| Principal Investigator: | Simon L Bacon, PhD | Hopital du Sacre-Coeur de Montreal / Concordia University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Simon Bacon, Researcher, Hopital du Sacre-Coeur de Montreal |
| ClinicalTrials.gov Identifier: | NCT00953342 History of Changes |
| Other Study ID Numbers: | MOP93807 |
| Study First Received: | August 4, 2009 |
| Last Updated: | October 16, 2012 |
| Health Authority: | Canada: Canadian Institutes of Health Research |
Keywords provided by Hopital du Sacre-Coeur de Montreal:
|
AEROBIC EXERCISE ASTHMA CONTROL ASTHMA QUALITY OF LIFE INFLAMMATION TREATMENT |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013