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Execise Intervention in Adult Severe Asthma

2026年6月15日 更新者:Hanna Hisinger-Mölkänen、Helsinki University Central Hospital

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

研究概览

地位

招聘中

详细说明

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.

研究类型

介入性

注册 (估计的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

  • 姓名:Annina Lyly, MD, PhD
  • 电话号码:+358 50 4287952
  • 邮箱:annina.lyly@hus.fi

学习地点

      • Helsinki、芬兰、00250
        • 招聘中
        • Helsinki University Hospital
        • 接触:
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的: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.
a 6 month personilized exercise plan with control and follow up including baseline fitness testing
无干预: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
The change in peak O2 consumption
大体时间:from enrollment to the end of the follow up period (6 months)
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)

次要结果测量

结果测量
措施说明
大体时间
The change in asthma symptom control
大体时间:From baseline to the end of the follow up period (6months)
Daily asthma symptoms measured with asthma control test
From baseline to the end of the follow up period (6months)
The change in asthma exacerbation frequency
大体时间:From baseline to the end of the follow up period (6 months)
A worsening of asthma symptoms and control treated with added medication, measured according to normal clinical practise
From baseline to the end of the follow up period (6 months)
The change in FVC and FEV1 in spirometry
大体时间:From baseline to the end of the follow up period (6 months)
The change in lung function measured with spirometry
From baseline to the end of the follow up period (6 months)
The change in asthma-related quality of life
大体时间: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
大体时间: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.
from baseline to the end of the follow up period (6months)
The change in body composition
大体时间:From baseline to the end of the follow up period (6months)
the change in body composition measured with InBody720 body composition analyzer.
From baseline to the end of the follow up period (6months)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Mika Mäkelä, prof、Helsinki University Central Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年3月18日

初级完成 (估计的)

2027年10月1日

研究完成 (估计的)

2028年10月1日

研究注册日期

首次提交

2026年4月9日

首先提交符合 QC 标准的

2026年6月15日

首次发布 (实际的)

2026年6月17日

研究记录更新

最后更新发布 (实际的)

2026年6月17日

上次提交的符合 QC 标准的更新

2026年6月15日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

the data collected will only be used in the study publications.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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