Exercise program for adults with severe asthma who are on biological treatment
Tests a tailored exercise program in adults with severe asthma on biological treatment.
Key facts
- Who runs it
- Helsinki University Central Hospital
- Where
- Helsinki, FinlandSee the site
- Trial code
- Registry title
- Execise Intervention in Adult Severe Asthma
- Status
- Recruiting
- People taking part
- 60 people, planned
- Started
- 18 Mar 2026
- Expected to end
- Oct 2028
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Exercise intervention
- Record updated
- 17 June 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with severe asthma who are about to start a biological medicine for it. It tests a 6-month exercise program.
- Age
- Over 18 years
- Sex
- All
- Disease stage
- Severe asthma diagnosed by a doctor using the GINA criteria
- Earlier treatment
- A decision has been made to start a biological treatment (omalizumab, mepolizumab, benralizumab, dupilumab or tezepelumab) for severe asthma
Main reasons for not taking part
- Major surgery coming up
- Acute muscle or joint disease that prevents regular exercise
- Cannot keep the appointments and exercise plan because of exhaustion or fatigue
- Pregnancy
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Finland
- Helsinki University HospitalHelsinki, FinlandContact: Hanna Hisinger-Mölkänen, MD, PhDTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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
The 2 groups in the trial
- ActiveTreatment being tested
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.
Treatment: Exercise intervention
- ControlNo study treatment, for comparison
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Exercise Intervention in Severe Asthma: a Randomized Controlled Trial in Adults on Biological Treatment for Asthma
- Plain-language title
- Exercise program for adults with severe asthma who are on biological treatmentGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 17 June 2026