RecruitingNot Applicable

Execise Intervention in Adult Severe Asthma

Finland60 participantsStarted 2026-03-18

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is measuring changes in peak oxygen consumption during exercise — can you explain what that means for my asthma symptoms day-to-day, and why it matters for someone with severe asthma like me?
2Since this study is listed as 'Phase NA,' which often means it's a non-drug intervention like an exercise program rather than a medication trial, can you walk me through exactly what the exercise sessions would involve and whether my current lung function is safe enough to participate?
3Severe asthma can make physical exertion risky — how would my care team monitor me during this trial to make sure I'm not putting myself at risk by increasing my exercise levels?
4Before considering an exercise intervention trial, should I make sure my severe asthma is as well-controlled as possible on my current medications first, or is this something that could run alongside my existing treatment plan?
5Are there standard pulmonary rehabilitation or supervised exercise programs already available outside of this trial that might offer similar benefits, so we can compare my options before deciding whether to pursue enrollment?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The change in peak O2 consumption

Timeframe: from enrollment to the end of the follow up period (6 months)

Trial details

NCT IDNCT07655037

SponsorHelsinki University Central Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-10

Contact for this trial

Hanna Hisinger-Mölkänen, MD, PhD

+358 40 6654484 hanna.hisinger-molkanen@hus.fi

View on ClinicalTrials.gov More Severe Asthma trials