- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Hanna Hisinger-Mölkänen, MD, PhD
- 전화번호: +358 40 6654484
- 이메일: hanna.hisinger-molkanen@hus.fi
연구 연락처 백업
- 이름: Annina Lyly, MD, PhD
- 전화번호: +358 50 4287952
- 이메일: annina.lyly@hus.fi
연구 장소
-
-
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Helsinki, 핀란드, 00250
- 모병
- Helsinki University Hospital
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연락하다:
- Hanna Hisinger-Mölkänen, MD, PhD
- 전화번호: +358 40 6654484
- 이메일: hanna.hisinger-molkanen@hus.fi
-
연락하다:
- Annina Lyly, MD, PhD
- 전화번호: +358 50 4287952
- 이메일: annina.lyly@hus.fi
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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
|
|
간섭 없음: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The change in peak O2 consumption
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
The change in asthma symptom control
기간: From baseline to the end of the follow up period (6months)
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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
기간: 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
기간: 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
기간: from baseline to the end of the follow up period (6months)
|
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
기간: 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
기간: 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)
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공동 작업자 및 조사자
수사관
- 연구 의자: Mika Mäkelä, prof, Helsinki University Central Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- §3/2026, HUS/20/2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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