Asthma
Conditions
Keywords
Asthma, Exercise, Asthma treatment, Inhaled corticosteroid, Rehabilitation
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.
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.
Interventions
BEHAVIORALHigh Intensity Interval Training
Training (HIIT)
Sponsors
Bispebjerg Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Single blindet, randomization and training intervention by non-investigator. Open-label after primary follow up. After unblinding, blindet 3rd party performs tests (visit 9 and 12 months, e.g. spirometry)
Intervention model description
A randomized, controlled parallel group, outcome assessor blinded, clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Exacerbation rate 12 months | 12 months +/- 7 days | Number of exacerbations (moderate-severe) at 12 months |
| Cumulated ICS 12 months | 12 months +/- 7 days | Change from baseline in cumulated dose of ICS 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 |
| 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 |
| 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 |
| Exacerbation rate 6 months | 6 months +/- 7 days | Number of exacerbations (moderate-severe) at 6 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Denmark
Outcome results
None listed