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Exercise Intervention in Severe Asthma: a Randomized Controlled Trial in Adults on Biological Treatment for Asthma

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Finland
Helsinki University Hospital
RECRUITING
Helsinki
Contact Information
Primary
Hanna Hisinger-Mölkänen, MD, PhD
hanna.hisinger-molkanen@hus.fi
+358 40 6654484
Backup
Annina Lyly, MD, PhD
annina.lyly@hus.fi
+358 50 4287952
Time Frame
Start Date: 2026-03-18
Estimated Completion Date: 2028-10
Participants
Target number of participants: 60
Treatments
Experimental: Active
Participants in the active group will receive an individual exercise plan and support for six months based on the baseline fitness test results. Fitness tests will be repeated in 6 months. Asthma pharmacological treatment, including biological therapy, will be administered according to standard clinical practice.
No_intervention: Control
Participants in the control group will undergo baseline fitness tests, which will then be repeated in 6 moths. Asthma pharmacological treatment, including biological therapy, will be administered according to standard clinical practice.
Related Therapeutic Areas
Sponsors
Leads: Helsinki University Central Hospital

This content was sourced from clinicaltrials.gov