Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Training group | Active Comparator | 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) |
|
| Control group | No Intervention | Control group, usual lifestyle. Aside from training intervention, all other visits are the same as intervention group (training). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Intensity Interval Training | Behavioral | Training (HIIT) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months +/- 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months +/- 7 days |
| Cumulated ICS 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months +/- 7 days |
| Eosinophilic subpopulation - exploratory analyses 12 months |
Inclusion Criteria:
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Vibeke Backer, professor | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Respiratory Research Unit, Birpebjerg Hospital | Copenhagen NV | 2400 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37256238 | Derived | Pitzner-Fabricius A, Dall CH, Henriksen M, Hansen ESH, Toennesen LL, Hostrup M, Backer V. Effect of High-Intensity Interval Training on Inhaled Corticosteroid Dose in Asthma Patients: A Randomized Controlled Trial. J Allergy Clin Immunol Pract. 2023 Jul;11(7):2133-2143.e8. doi: 10.1016/j.jaip.2023.04.013. Epub 2023 May 31. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 2, 2017 | Dec 23, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 22, 2020 | Dec 23, 2020 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001249 | Asthma |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000072696 | High-Intensity Interval Training |
| D012681 | Sensitivity Training Groups |
| ID | Term |
|---|---|
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
Not provided
Not provided
A randomized, controlled parallel group, outcome assessor blinded, clinical trial
Not provided
Not provided
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)
Change from baseline in cumulated dose of ICS at 6 months
| 6 months +/- 7 days |
| Cumulated ICS 12 months | Change from baseline in cumulated dose of ICS at 12 months | 12 months +/- 7 days |
| Cumulated Long acting beta2 agonists (LABA) 6 months | Change from baseline in cumulated dose of LABA at 6 months | 6 months +/- 7 days |
| Cumulated LABA 12 months | Change from baseline in cumulated dose of LABA at 12 months | 12 months +/- 7 days |
| Exacerbation rate 6 months | Number of exacerbations (moderate-severe) at 6 months | 6 months +/- 7 days |
| Exacerbation rate 12 months | Number of exacerbations (moderate-severe) at 12 months | 12 months +/- 7 days |
| miniAQLQ 6 months | Change from baseline in Asthma life quality evaluated by miniAQLQ at 6 months | 6 months +/- 7 days |
| miniAQLQ 12 months | Change from baseline in Asthma life quality evaluated by miniAQLQ at 12 months | 12 months +/- 7 days |
| Fraction of exhaled Nitrogen Oxid 6 months | Change from baseline in Airway inflammation evaluated by FeNO at 6 months | 6 months +/- 7 days |
| Fraction of exhaled Nitrogen Oxid 12 months | Change from baseline in Airway inflammation evaluated by FeNO at 12 months | 12 months +/- 7 days |
| Sputum cell count 6 months | Change from baseline in Airway inflammation evaluated by sputum cell count at 6 months | 6 months +/- 7 days |
| Sputum cell count 12 months | Change from baseline in Airway inflammation evaluated by sputum cell count at 12 months | 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 | 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 | 12 months +/- 7 days |
| Airway hyperresponsiveness | Change from baseline in airway hyperresponsiveness measured by methacholine test at 6 months | 6 months +/- 7 days |
| FEV1 6 months | Change from baseline in lung function evaluated by FEV1 at 6 months | 6 months +/- 7 days |
| FVC 6 months | Change from baseline in lung function evaluated by FVC at 6 months | 6 months +/- 7 days |
| FEV1 12 months | Change from baseline in lung function evaluated by FEV1 at 12 months | 12 months +/- 7 days |
| FVC 12 months | Change from baseline in lung function evaluated by FVC at 12 months | 12 months +/- 7 days |
| Cardiopulmonary fitness | Change from baseline in cardiopulmonary fitness evaluated by maximum oxygen consumption at 6 months (VO2max) | 6 months +/- 7 days |
| Change in fat and muscle composition (DEXA scan) | Change from baseline in fat and muscle composition evaluated by DEXA scan | 6 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. |
| 12 months +/- 7 days |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D001519 | Behavior |
| D009142 |
| Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D011615 | Psychotherapy, Group |
| D012960 | Socioenvironmental Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |