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

This study is currently recruiting participants. (see Contacts and Locations)
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
  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

Resource links provided by NLM:


Further study details as provided by Hopital du Sacre-Coeur de Montreal:

Primary Outcome Measures:
  • Asthma control Questionnaire (Juniper) [ Time Frame: Within 1 week of completion of the intervention (i.e., after 12 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00953342

Contacts
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

Locations
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         
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
  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 September 30, 2014