NCT07655037 Execise Intervention in Adult Severe Asthma
| NCT ID | NCT07655037 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Helsinki University Central Hospital |
| Condition | Severe Asthma |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-03-18 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2026-03-18 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Mika Mäkelä, prof
STUDY CHAIR
Helsinki University Central Hospital
Frequently Asked Questions
Who can join the NCT07655037 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Severe Asthma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07655037 currently recruiting?
Yes, NCT07655037 is actively recruiting participants. Contact the research team at hanna.hisinger-molkanen@hus.fi for enrollment information.
Where is the NCT07655037 trial being conducted?
This trial is being conducted at Helsinki, Finland.
Who is sponsoring the NCT07655037 clinical trial?
NCT07655037 is sponsored by Helsinki University Central Hospital. The principal investigator is Mika Mäkelä, prof at Helsinki University Central Hospital. The trial plans to enroll 60 participants.
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