Execise Intervention in Adult Severe Asthma

NCT07655037 | Recruiting

• 1 other identifier: §3/2026, HUS/20/2026
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Severe Asthma; Asthma

Keywords

severe asthma; biological treatment

Outcome Measures

Primary Outcomes (1)

• The change in peak O2 consumption

  The change in exercise capacity in cardiopulmonary exercise test (spiroergometry) measured as the peak O2 consumption (VO2peak)

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

Secondary Outcomes (6)

• The change in asthma symptom control

  From baseline to the end of the follow up period (6months)

• The change in asthma exacerbation frequency

  From baseline to the end of the follow up period (6 months)

• The change in FVC and FEV1 in spirometry

  From baseline to the end of the follow up period (6 months)

• The change in asthma-related quality of life

  from baseline to the end of the follow up period (6months)

• The change in body mass index

  from baseline to the end of the follow up period (6months)

Study Arms (2)

Active

EXPERIMENTAL

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.

Other: Exercise intervention

Control

NO INTERVENTION

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.

Interventions

Exercise intervention OTHER

a 6 month personilized exercise plan with control and follow up including baseline fitness testing

Active

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

Helsinki University Hospital

Helsinki, 00250, Finland

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Mika Mäkelä, prof

  Helsinki University Central Hospital

  STUDY CHAIR

Central Study Contacts

Hanna Hisinger-Mölkänen, MD, PhD

CONTACT

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

Annina Lyly, MD, PhD

CONTACT

+358 50 4287952; annina.lyly@hus.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Head of department

Model Details: A randomized controlled trial

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: June 17, 2026
• Study Start: March 18, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)