Execise Intervention in Adult Severe Asthma
Exercise Intervention in Severe Asthma: a Randomized Controlled Trial in Adults on Biological Treatment for Asthma
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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Severe asthma is a chronic condition characterized by persistent symptoms and frequent exacerbations despite optimized pharmacological treatment. In recent years, biological therapies have significantly improved asthma control in many patients. However, individuals with severe asthma often remain physically inactive due to long-standing symptoms, reduced exercise tolerance, and fear of symptom worsening. This inactivity may contribute to reduced physical fitness, poorer quality of life, and additional health problems.
Regular physical activity has been shown to improve asthma control, exercise capacity, and health-related quality of life in individuals with asthma. Despite this, structured and individualized exercise programs are not routinely included in standard asthma care. Furthermore, there is limited evidence on the effects of exercise interventions specifically in patients with severe asthma who are receiving biological therapies.
The aim of this randomized controlled trial is to evaluate whether an individually tailored exercise intervention can improve exercise capacity and asthma control in adults with severe asthma who are initiating biological treatment. The study also aims to assess the effects of the intervention on asthma symptoms, exacerbation frequency, lung function, quality of life, and body composition.
This study will be conducted at the Adult Unit of the Skin and Allergy Hospital, Helsinki University Hospital. Adult patients (aged 18 years or older) with physician-diagnosed severe asthma starting biological therapy as part of their routine care, will be invited to participate. Approximately 40-60 participants are expected to be enrolled.
After providing informed consent, participants will undergo baseline assessments, including cardiopulmonary exercise testing (spiroergometry), muscle strength testing, a six-minute walking test, and body composition measurements. In addition, participants will complete validated questionnaires assessing asthma control, asthma-related quality of life, and general wellbeing.
Participants will then be randomized in a 1:1 ratio to either an intervention group or a control group. The intervention group will receive an individualized exercise program designed and guided by a physiotherapist and a sports medicine specialist. The exercise plan will be tailored based on each participant's baseline fitness level, health status, and personal circumstances. The program will last for six months and will include follow-up support, such as a phone contact at one month and a physiotherapy visit at three months. Participants will also be provided with tools such as an exercise diary and a step counter to support adherence.
The control group will receive standard care, including general advice on the benefits of physical activity, but no structured or personalized exercise program. All participants in both groups will continue their usual asthma treatment, including biological therapy, according to standard clinical practice.
At six months, all baseline assessments will be repeated to evaluate changes in physical fitness and other outcomes. Asthma control will be further assessed at 12 months.
The primary outcome of the study is the change in exercise capacity, measured as peak oxygen uptake (VO₂peak) during cardiopulmonary exercise testing. Secondary outcomes include changes in asthma symptom control, frequency of exacerbations, lung function (FVC and FEV₁), asthma-related quality of life, and body composition (body mass index and waist circumference).
All data will be collected and managed securely in accordance with data protection regulations. Participation in the study is voluntary, and participants may withdraw at any time without affecting their standard medical care.
The results of this study will provide new evidence on whether personalized exercise interventions can enhance the benefits of biological therapy in severe asthma and support the development of more comprehensive, patient-centered treatment strategies.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Hanna Hisinger-Mölkänen, MD, PhD
- Numéro de téléphone: +358 40 6654484
- E-mail: hanna.hisinger-molkanen@hus.fi
Sauvegarde des contacts de l'étude
- Nom: Annina Lyly, MD, PhD
- Numéro de téléphone: +358 50 4287952
- E-mail: annina.lyly@hus.fi
Lieux d'étude
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Helsinki, Finlande, 00250
- Recrutement
- Helsinki University Hospital
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Contact:
- Hanna Hisinger-Mölkänen, MD, PhD
- Numéro de téléphone: +358 40 6654484
- E-mail: hanna.hisinger-molkanen@hus.fi
-
Contact:
- Annina Lyly, MD, PhD
- Numéro de téléphone: +358 50 4287952
- E-mail: annina.lyly@hus.fi
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
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a 6 month personilized exercise plan with control and follow up including baseline fitness testing
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Aucune 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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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The change in peak O2 consumption
Délai: from enrollment to the end of the follow up period (6 months)
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The change in exercise capacity in cardiopulmonary exercise test (spiroergometry) measured as the peak O2 consumption (VO2peak)
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from enrollment to the end of the follow up period (6 months)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The change in asthma symptom control
Délai: From baseline to the end of the follow up period (6months)
|
Daily asthma symptoms measured with asthma control test
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From baseline to the end of the follow up period (6months)
|
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The change in asthma exacerbation frequency
Délai: From baseline to the end of the follow up period (6 months)
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A worsening of asthma symptoms and control treated with added medication, measured according to normal clinical practise
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From baseline to the end of the follow up period (6 months)
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The change in FVC and FEV1 in spirometry
Délai: From baseline to the end of the follow up period (6 months)
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The change in lung function measured with spirometry
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From baseline to the end of the follow up period (6 months)
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The change in asthma-related quality of life
Délai: from baseline to the end of the follow up period (6months)
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the change in daily life quality measured with AQLQ questionnaire
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from baseline to the end of the follow up period (6months)
|
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The change in body mass index
Délai: from baseline to the end of the follow up period (6months)
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change in body mass index (weight measured with InBody720 body composition analyzer and height measured with Holtain Limited measuring device.
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from baseline to the end of the follow up period (6months)
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The change in body composition
Délai: From baseline to the end of the follow up period (6months)
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the change in body composition measured with InBody720 body composition analyzer.
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From baseline to the end of the follow up period (6months)
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Mika Mäkelä, prof, Helsinki University Central Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- §3/2026, HUS/20/2026
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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