Execise Intervention in Adult Severe Asthma

Sponsor
Helsinki University Central Hospital
Study ID
NCT07655037
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Exercise intervention — OTHER
    a 6 month personilized exercise plan with control and follow up including baseline fitness testing

Study Details

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

Key Dates

First listed
Jun 17, 2026
Start date
Mar 18, 2026
Status verified
Jun 2026
Primary completion
Oct 31, 2027
Completion
Oct 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

The change in peak O2 consumption [ Time Frame: from enrollment to the end of the follow up period (6 months) ]

Central Contacts

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