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AsthmaPhase 3Ex-AsthmaNCT00953342

Impact of Aerobic Exercise on Asthma Morbidity

A Phase 3 study testing Aerobic exercise in people with Asthma, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 3 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Asthma
What is being tested?
Aerobic exercise
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
66 participants
Where
3 sitesCanada
Study dates
Jan 2010to Aug 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country.

Canada3 sites
  • Montreal Chest Institute

    Montreal, Quebec, H2X 2P4

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Hopital du Sacre-Coeur de Montreal

    Montreal, Quebec, H4J 1C5

Other trials in Canada

About this study

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.

Read the detailed description

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.

Conditions
Asthma
Being tested
Aerobic exercise, Usual care
Keywords
AEROBIC EXERCISE, ASTHMA CONTROL, ASTHMA QUALITY OF LIFE, INFLAMMATION, TREATMENT
Medical subject headings
Asthma, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aerobic exerciseBehavioural

    12 weeks of supervised exercise, 3 x week, 1 hour sessions

  • Usual careBehavioural

    Standard medical care

Study groups in NCT00953342
Study groupRoleWhat they receive
Aerobic exerciseExperimental12 weeks of supervised aerobic exercise and standard care
Receives: Behavioral: Aerobic exercise
Usual carePlacebo comparator12 weeks of standard care
Receives: Behavioral: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Asthma control Questionnaire (Juniper)

    Measured: Within 1 week of completion of the intervention (i.e., after 12 weeks)

Secondary outcomes (3)
  1. Asthma quality of life questionnaire (Juniper)

    Measured: Within 1 week of completion of the intervention (i.e., after 12 weeks)

  2. Asthma control test

    Measured: Within 1 week of completion of the intervention (i.e., after 12 weeks)

  3. Inflammatory markers

    Measured: Within 1 week of completion of the intervention (i.e., after 12 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2009 (estimated)
  2. Study startJan 2010
  3. Primary completionJul 2013
  4. Study completionAug 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00953342
Sponsor's protocol ID
MOP93807
Acronym
Ex-Asthma
Status last verified
Jun 2016
First submitted
4 Aug 2009
Last updated
12 Feb 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 23794569

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aerobic exercise in people with Asthma, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 3 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Asthma control Questionnaire (Juniper) (time frame: Within 1 week of completion of the intervention (i.e., after 12 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00953342, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2018.

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