Execise Intervention in Adult Severe Asthma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHelsinki University Central Hospital
About this trial
Physical activity has been shown to improve asthma control in individuals with asthma. Patients with severe asthma frequently experience exacerbations, which often result in a physically inactive lifestyle. The investigators therefore hypothesize that patients with severe asthma who initiate biological therapy may particularly benefit from increased physical activity, both in terms of exercise capacity and asthma control.
The aim of this study is to determine whether an individually tailored exercise program improves exercise capacity and asthma control in patients with severe asthma. Additionally, the study evaluates the effects of the intervention on asthma symptoms, frequency of exacerbations, lung function, quality of life, and body composition.
The primary outcome is the change in exercise tolerance, measured as peak oxygen uptake during cardiopulmonary exercise testing.
Secondary outcomes include asthma symptoms (proportion of patients reporting improvement based on the Asthma Control Test), frequency of exacerbations, changes in lung function (FVC and FEV1), asthma-related quality of life (AQLQ), and changes in body composition (body mass index and waist circumference).
At baseline, all participants undergo fitness assessments, including cardiopulmonary exercise testing and muscle strength tests. Participants are then randomized into two groups. The intervention group receives an individually tailored 6-month exercise program designed by a sports medicine physician and a physiotherapist based on baseline fitness level. The control group receives standard advice to increase physical activity. Asthma medication is managed according to standard clinical practice in both groups.
Fitness assessments are repeated at 6 months for all participants, and asthma control is evaluated at 6 and 12 months
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age over 18 years
Physician-diagnosed severe asthma defined with the GINA criteria and with a decision to initiate biological treatment (omalizumab, mepolizumab, benralizumab, dupilumab or tezepelumab) for severe asthma
Disqualifiers
Upcoming major surgery
Acute musculoskeletal disease which unables regular exercise
Inability to commit to the appointments and the exercise plan due to exhaustion or fatigue
Pregnancy
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise intervention
Other interventiona 6 month personilized exercise plan with control and follow up including baseline fitness testing
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: ActiveExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
The change in peak O2 consumption
The change in exercise capacity in cardiopulmonary exercise test (spiroergometry) measured as the peak O2 consumption (VO2peak)
Time frame
from enrollment to the end of the follow up period (6 months)Secondary outcomes
1
The change in asthma symptom control
Daily asthma symptoms measured with asthma control test
Time frame
From baseline to the end of the follow up period (6months)2
The change in asthma exacerbation frequency
A worsening of asthma symptoms and control treated with added medication, measured according to normal clinical practise
Time frame
From baseline to the end of the follow up period (6 months)3
The change in FVC and FEV1 in spirometry
The change in lung function measured with spirometry
Time frame
From baseline to the end of the follow up period (6 months)4
The change in asthma-related quality of life
the change in daily life quality measured with AQLQ questionnaire
Time frame
from baseline to the end of the follow up period (6months)Sponsors and contacts
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Source ClinicalTrials.gov