An interventional study of High Intensity Interval Training in Asthma, sponsored by Bispebjerg Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-03-15.
Sponsored by Bispebjerg Hospital · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Subjects, who by investigators determination, will not be able to adhere to study protocol
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
Control group, usual lifestyle. Aside from training intervention, all other visits are the same as intervention group (training).
Training (HIIT)
Also known as: Training group
Reduced inhaled corticosteroid (ICS) 6 months
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
Time frame: 6 months +/- 7 days
Reduced inhaled corticosteroid (ICS) 12 months
The proportion of participants at 12 months that have been down-titrated in ICS dose by at least 25 % compared to baseline.
Time frame: 12 months +/- 7 days
Cumulated ICS 6 months
Change from baseline in cumulated dose of ICS at 6 months
Time frame: 6 months +/- 7 days
Cumulated ICS 12 months
Change from baseline in cumulated dose of ICS at 12 months
Time frame: 12 months +/- 7 days
Cumulated Long acting beta2 agonists (LABA) 6 months
Change from baseline in cumulated dose of LABA at 6 months
Time frame: 6 months +/- 7 days
Cumulated LABA 12 months
Change from baseline in cumulated dose of LABA at 12 months
Time frame: 12 months +/- 7 days
Exacerbation rate 6 months
Number of exacerbations (moderate-severe) at 6 months
Time frame: 6 months +/- 7 days
Exacerbation rate 12 months
Number of exacerbations (moderate-severe) at 12 months
Time frame: 12 months +/- 7 days
miniAQLQ 6 months
Change from baseline in Asthma life quality evaluated by miniAQLQ at 6 months
Time frame: 6 months +/- 7 days
miniAQLQ 12 months
Change from baseline in Asthma life quality evaluated by miniAQLQ at 12 months
Time frame: 12 months +/- 7 days
Fraction of exhaled Nitrogen Oxid 6 months
Change from baseline in Airway inflammation evaluated by FeNO at 6 months
Time frame: 6 months +/- 7 days
Fraction of exhaled Nitrogen Oxid 12 months
Change from baseline in Airway inflammation evaluated by FeNO at 12 months
Time frame: 12 months +/- 7 days
Sputum cell count 6 months
Change from baseline in Airway inflammation evaluated by sputum cell count at 6 months
Time frame: 6 months +/- 7 days
Sputum cell count 12 months
Change from baseline in Airway inflammation evaluated by sputum cell count at 12 months
Time frame: 12 months +/- 7 days
Systemic inflammation 6 months
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
Time frame: 6 months +/- 7 days
Systemic inflammation 12 months
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
Time frame: 12 months +/- 7 days
Airway hyperresponsiveness
Change from baseline in airway hyperresponsiveness measured by methacholine test at 6 months
Time frame: 6 months +/- 7 days
FEV1 6 months
Change from baseline in lung function evaluated by FEV1 at 6 months
Time frame: 6 months +/- 7 days
FVC 6 months
Change from baseline in lung function evaluated by FVC at 6 months
Time frame: 6 months +/- 7 days
FEV1 12 months
Change from baseline in lung function evaluated by FEV1 at 12 months
Time frame: 12 months +/- 7 days
FVC 12 months
Change from baseline in lung function evaluated by FVC at 12 months
Time frame: 12 months +/- 7 days
Cardiopulmonary fitness
Change from baseline in cardiopulmonary fitness evaluated by maximum oxygen consumption at 6 months (VO2max)
Time frame: 6 months +/- 7 days
Change in fat and muscle composition (DEXA scan)
Change from baseline in fat and muscle composition evaluated by DEXA scan
Time frame: 6 months +/- 7 days
Eosinophilic subpopulation - exploratory analyses 6 months
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.
Time frame: 6 months +/- 7 days
Eosinophilic subpopulation - exploratory analyses 12 months
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.
Time frame: 12 months +/- 7 days
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Bispebjerg Hospital