REPLACE: Can Exercise Replace Inhaled Corticosteroid Treatment in Asthma? A RCT

Bispebjerg Hospital

Status: Completed

Conditions: Asthma

Treatments: Behavioral: High Intensity Interval Training

Study type: Interventional

Funder types: Other

Identifiers

NCT03290898

REPLACE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups

Training group

Active Comparator group

Description:

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)

Treatment:

Behavioral: High Intensity Interval Training

Control group

No Intervention group

Description:

Control group, usual lifestyle. Aside from training intervention, all other visits are the same as intervention group (training).