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

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ClinicalTrials.gov Identifier: NCT00953342
Recruitment Status : Completed
First Posted : August 6, 2009
Last Update Posted : February 12, 2018
Sponsor:
Collaborators:
McGill University Health Center
Jewish General Hospital
Information provided by (Responsible Party):
Simon Bacon, Hopital du Sacre-Coeur de Montreal

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.

Condition or disease Intervention/treatment Phase
Asthma Behavioral: Aerobic exercise Behavioral: Usual care Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Aerobic Exercise on Asthma Morbidity
Study Start Date : January 2010
Actual Primary Completion Date : July 2013
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Asthma control Questionnaire (Juniper) [ Time Frame: Within 1 week of completion of the intervention (i.e., after 12 weeks) ]

Secondary Outcome Measures :
  1. Asthma quality of life questionnaire (Juniper) [ Time Frame: Within 1 week of completion of the intervention (i.e., after 12 weeks) ]
  2. Asthma control test [ Time Frame: Within 1 week of completion of the intervention (i.e., after 12 weeks) ]
  3. Inflammatory markers [ Time Frame: Within 1 week of completion of the intervention (i.e., after 12 weeks) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00953342


Locations
Canada, Quebec
Montreal Chest Institute
Montreal, Quebec, Canada, H2X 2P4
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada, H4J 1C5
Sponsors and Collaborators
Hopital du Sacre-Coeur de Montreal
McGill University Health Center
Jewish General Hospital
Investigators
Principal Investigator: Simon L Bacon, PhD Hopital du Sacre-Coeur de Montreal / Concordia University

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Simon Bacon, Researcher, Hopital du Sacre-Coeur de Montreal
ClinicalTrials.gov Identifier: NCT00953342     History of Changes
Other Study ID Numbers: MOP93807
First Posted: August 6, 2009    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: June 2016

Keywords provided by Simon Bacon, 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