REPLACE: Can Exercise Replace Inhaled Corticosteroid Treatment in Asthma? A RCT
Study Details
Study Description
Brief Summary
To evaluate if physical exercise intervention leads to an improved asthma control as measured by Asthma Control Questionnaire (ACQ-5) in such a magnitude that inhaled corticosteroid can be reduces in asthmatics.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
At least 102 asthmatics will be randomized 2:1 (2 to training group; 1 to control) and undergo 6 months of intervention or usual lifestyle.
Subjects must have confirmed asthma diagnosis, on a stable treatment with inhaled corticosteroid, symptomatic and untrained.
At enrollment and during the study asthma medicine is adjusted based on asthma symptoms evaluated by ACQ-5. 6 treatment steps are pre-defined, and if well controlled asthma, subjects are down-titrated one step, if uncontrolled, subjects are uptitrated one step.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Training group Supervised High intensity interval training (HIIT) 3 times a week for 6 months. Training session: 10 minutes warm up (Low-moderate intensity) 30 minutes intervention (16 minutes HIIT) 10 minutes cool down(Low-moderate intensity) |
Behavioral: High Intensity Interval Training
Training (HIIT)
Other Names:
|
| No Intervention: Control group Control group, usual lifestyle. Aside from training intervention, all other visits are the same as intervention group (training). |
Outcome Measures
Primary Outcome Measures
- Reduced inhaled corticosteroid (ICS) 6 months [6 months +/- 7 days]
The proportion of participants at 6 months that have been down-titrated in ICS dose by at least 25% compared to the participants' baseline dose
Secondary Outcome Measures
- Reduced inhaled corticosteroid (ICS) 12 months [12 months +/- 7 days]
The proportion of participants at 12 months that have been down-titrated in ICS dose by at least 25 % compared to baseline.
- Cumulated ICS 6 months [6 months +/- 7 days]
Change from baseline in cumulated dose of ICS at 6 months
- Cumulated ICS 12 months [12 months +/- 7 days]
Change from baseline in cumulated dose of ICS at 12 months
- Cumulated Long acting beta2 agonists (LABA) 6 months [6 months +/- 7 days]
Change from baseline in cumulated dose of LABA at 6 months
- Cumulated LABA 12 months [12 months +/- 7 days]
Change from baseline in cumulated dose of LABA at 12 months
- Exacerbation rate 6 months [6 months +/- 7 days]
Number of exacerbations (moderate-severe) at 6 months
- Exacerbation rate 12 months [12 months +/- 7 days]
Number of exacerbations (moderate-severe) at 12 months
- miniAQLQ 6 months [6 months +/- 7 days]
Change from baseline in Asthma life quality evaluated by miniAQLQ at 6 months
- miniAQLQ 12 months [12 months +/- 7 days]
Change from baseline in Asthma life quality evaluated by miniAQLQ at 12 months
- Fraction of exhaled Nitrogen Oxid 6 months [6 months +/- 7 days]
Change from baseline in Airway inflammation evaluated by FeNO at 6 months
- Fraction of exhaled Nitrogen Oxid 12 months [12 months +/- 7 days]
Change from baseline in Airway inflammation evaluated by FeNO at 12 months
- Sputum cell count 6 months [6 months +/- 7 days]
Change from baseline in Airway inflammation evaluated by sputum cell count at 6 months
- Sputum cell count 12 months [12 months +/- 7 days]
Change from baseline in Airway inflammation evaluated by sputum cell count at 12 months
- Systemic inflammation 6 months [6 months +/- 7 days]
Change from baseline in systemic inflammation evaluated by blood eosinophilic, hsCRP and inflammatory cytokines (e.g. IL-6 and IL-8) and TNF-alfa at 6 months
- Systemic inflammation 12 months [12 months +/- 7 days]
Change from baseline in systemic inflammation evaluated by blood eosinophilic, hsCRP and inflammatory cytokines (e.g. IL-6 and IL-8) and TNF-alfa at 12 months
- Airway hyperresponsiveness [6 months +/- 7 days]
Change from baseline in airway hyperresponsiveness measured by methacholine test at 6 months
- FEV1 6 months [6 months +/- 7 days]
Change from baseline in lung function evaluated by FEV1 at 6 months
- FVC 6 months [6 months +/- 7 days]
Change from baseline in lung function evaluated by FVC at 6 months
- FEV1 12 months [12 months +/- 7 days]
Change from baseline in lung function evaluated by FEV1 at 12 months
- FVC 12 months [12 months +/- 7 days]
Change from baseline in lung function evaluated by FVC at 12 months
- Cardiopulmonary fitness [6 months +/- 7 days]
Change from baseline in cardiopulmonary fitness evaluated by maximum oxygen consumption at 6 months (VO2max)
- Change in fat and muscle composition (DEXA scan) [6 months +/- 7 days]
Change from baseline in fat and muscle composition evaluated by DEXA scan
Other Outcome Measures
- Eosinophilic subpopulation - exploratory analyses 6 months [6 months +/- 7 days]
To evaluate the effect of the intervention in sub-populations of asthmatics using different cut-off values of blood eosinophilics. Both regarding primary outcome and secondary outcomes.
- Eosinophilic subpopulation - exploratory analyses 12 months [12 months +/- 7 days]
To evaluate the effect of the intervention in sub-populations of asthmatics using different cut-off values of blood eosinophilics with regards to secondary outcomes at 12 months.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Asthma (The diagnose of asthma is based on symptoms and at least one positive asthma test the last 5 years (AHR to either mannitol or methacholine, reversibility to beta2-agonist, peak flow variation or positive eucapnic voluntary hyperventilation test))
-
ACQ ≥ 1 and ≤ 2.5
-
On a daily dose of ICS at a minimum of 400 µg budesonide or equivalent ICS for 3 months and with no changes in asthma medicine 4 weeks prior to enrollment
-
Untrained (no participation in vigorous exercise for more than 1 hour per week during the last 2 month)
-
Capable of exercising on bike
Exclusion Criteria:
-
Unable to speak and understand Danish
-
Infection within 4 weeks prior to visit 100*
-
Asthma exacerbation within 4 weeks prior to visit 100*
-
Hospitalized for an asthma attack during the last 2 months
-
Treatment with immunotherapy within 5 T½ of the treatment drug prior to visit 100
-
Initiation of allergen immunotherapy within 3 months prior to visit 100 or plan to begin therapy during study period
-
Treatment with peroral prednisolone
-
Respiratory: other chronic pulmonary disease of clinically significance
-
Cardiovascular: Unstable ischemic heart disease, myocardial infarction within the last 12 months, symptomatic heart failure (NYHA III-IV or EF <40%), symptomatic heart arrhythmia (documented with ECG), uncontrolled hypertension (>155/100)
-
Pregnancy or breastfeeding or planned pregnancy within the next 12 months
-
Other inflammatory or metabolic diseases with the exception of rhinitis, atopy and well-controlled hypothyroidism treated with or without Eltroxin
-
Vaccination less than 2 weeks prior to any visit
-
Current or former smokers with > 20 pack years
-
Subjects, who by investigators determination, will not be able to adhere to study protocol
-
If patients are excluded due to a recent infection or exacerbation they can undergo re-screening after a total of 4 weeks after end of exacerbation treatment/clearing the infection.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Respiratory Research Unit, Birpebjerg Hospital | Copenhagen NV | Denmark | 2400 |
Sponsors and Collaborators
- Bispebjerg Hospital
Investigators
- Principal Investigator: Vibeke Backer, professor, Rigshospitalet, Denmark
Study Documents (Full-Text)
More Information
Publications
None provided.- REPLACE