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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| Aerobic exercise | Experimental | 12 weeks of supervised aerobic exercise and standard care Receives: Behavioral: Aerobic exercise |
| Usual care | Placebo comparator | 12 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.
Asthma control Questionnaire (Juniper)
Measured: Within 1 week of completion of the intervention (i.e., after 12 weeks)
Secondary outcomes (3)
Asthma quality of life questionnaire (Juniper)
Measured: Within 1 week of completion of the intervention (i.e., after 12 weeks)
Asthma control test
Measured: Within 1 week of completion of the intervention (i.e., after 12 weeks)
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.
- First posted6 Aug 2009 (estimated)
- Study startJan 2010
- Primary completionJul 2013
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre, Jewish General Hospital
- Responsible party
- Principal investigator, Simon Bacon, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Investigators
- Simon L Bacon, PhD, Principal investigator, Hopital du Sacre-Coeur de Montreal / Concordia University
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Aerobic Exercise on Asthma Morbidity
- ClinicalTrials.gov ID
- NCT00953342
- Acronym / sponsor ID
- Ex-Asthma / MOP93807
- Conditions
- Asthma
- Keywords
- AEROBIC EXERCISE, ASTHMA CONTROL, ASTHMA QUALITY OF LIFE, INFLAMMATION, TREATMENT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de MontrealUniversity, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre, Jewish General Hospital
- Study start
- Jan 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 6 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise | Experimental | Behavioral: Aerobic exercise12 weeks of supervised aerobic exercise and standard care |
| Usual care | Placebo comparator | Behavioral: Usual care12 weeks of standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exercise12 weeks of supervised exercise, 3 x week, 1 hour sessions | Behavioural | Aerobic exercise |
| Usual careStandard medical care | Behavioural | Usual care |
Primary outcome
Asthma control Questionnaire (Juniper)
Time frame: Within 1 week of completion of the intervention (i.e., after 12 weeks)
3 secondary outcomes
Asthma quality of life questionnaire (Juniper)
Time frame: Within 1 week of completion of the intervention (i.e., after 12 weeks)
Asthma control test
Time frame: Within 1 week of completion of the intervention (i.e., after 12 weeks)
Inflammatory markers
Time frame: Within 1 week of completion of the intervention (i.e., after 12 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2018.
- Derived from this study: PubMed 23794569Bacon 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.
- PI's homepageLink provided by the sponsor.
- Research Centre, Hopital de Sacre-Coeur de Montreal's homepageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon L Bacon, PhD principal investigator
Hopital du Sacre-Coeur de Montreal / Concordia University
3 sites in 1 country: see every site and its status.
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.