- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07655037
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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Hanna Hisinger-Mölkänen, MD, PhD
- Número de teléfono: +358 40 6654484
- Correo electrónico: hanna.hisinger-molkanen@hus.fi
Copia de seguridad de contactos de estudio
- Nombre: Annina Lyly, MD, PhD
- Número de teléfono: +358 50 4287952
- Correo electrónico: annina.lyly@hus.fi
Ubicaciones de estudio
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Helsinki, Finlandia, 00250
- Reclutamiento
- Helsinki University Hospital
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Contacto:
- Hanna Hisinger-Mölkänen, MD, PhD
- Número de teléfono: +358 40 6654484
- Correo electrónico: hanna.hisinger-molkanen@hus.fi
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Contacto:
- Annina Lyly, MD, PhD
- Número de teléfono: +358 50 4287952
- Correo electrónico: annina.lyly@hus.fi
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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.
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a 6 month personilized exercise plan with control and follow up including baseline fitness testing
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Sin intervención: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The change in peak O2 consumption
Periodo de tiempo: 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)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The change in asthma symptom control
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: From baseline to the end of the follow up period (6 months)
|
The change in lung function measured with spirometry
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From baseline to the end of the follow up period (6 months)
|
|
The change in asthma-related quality of life
Periodo de tiempo: from baseline to the end of the follow up period (6months)
|
the change in daily life quality measured with AQLQ questionnaire
|
from baseline to the end of the follow up period (6months)
|
|
The change in body mass index
Periodo de tiempo: from baseline to the end of the follow up period (6months)
|
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
Periodo de tiempo: From baseline to the end of the follow up period (6months)
|
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)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Mika Mäkelä, prof, Helsinki University Central Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- §3/2026, HUS/20/2026
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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