REPLACE: Can Exercise Replace Inhaled Corticosteroid Treatment in Asthma? A RCT
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable asthma
Started Oct 2017
Typical duration for not_applicable asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2017
CompletedFirst Posted
Study publicly available on registry
September 25, 2017
CompletedStudy Start
First participant enrolled
October 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 26, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 4, 2020
CompletedMarch 15, 2021
March 1, 2021
2.7 years
September 18, 2017
March 11, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (22)
Reduced inhaled corticosteroid (ICS) 12 months
12 months +/- 7 days
Cumulated ICS 6 months
6 months +/- 7 days
Cumulated ICS 12 months
12 months +/- 7 days
Cumulated Long acting beta2 agonists (LABA) 6 months
6 months +/- 7 days
Cumulated LABA 12 months
12 months +/- 7 days
- +17 more secondary outcomes
Other Outcomes (2)
Eosinophilic subpopulation - exploratory analyses 6 months
6 months +/- 7 days
Eosinophilic subpopulation - exploratory analyses 12 months
12 months +/- 7 days
Study Arms (2)
Training group
ACTIVE COMPARATORSupervised 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 INTERVENTIONControl group, usual lifestyle. Aside from training intervention, all other visits are the same as intervention group (training).
Interventions
Training (HIIT)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Respiratory Research Unit, Birpebjerg Hospital
Copenhagen NV, 2400, Denmark
Related Publications (1)
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.
PMID: 37256238DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vibeke Backer, professor
Rigshospitalet, Denmark
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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)
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor dr.med.
Study Record Dates
First Submitted
September 18, 2017
First Posted
September 25, 2017
Study Start
October 13, 2017
Primary Completion
June 26, 2020
Study Completion
December 4, 2020
Last Updated
March 15, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share