[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641729":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":38,"responsibleParty":55,"collaborators":18,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":18,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":18,"enrollmentInfo":68,"targetDuration":18,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":41,"whyStopped":18,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Helsinki University Central Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Other: Exercise intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Exercise intervention","a 6 month personilized exercise plan with control and follow up including baseline fitness testing",[9],[25],{"name":26,"affiliation":5,"role":27},"Mika Mäkelä, prof","STUDY_CHAIR",[29,34],{"name":30,"role":31,"phone":32,"phoneExt":18,"email":33},"Hanna Hisinger-Mölkänen, MD, PhD","CONTACT","+358 40 6654484","hanna.hisinger-molkanen@hus.fi",{"name":35,"role":31,"phone":36,"phoneExt":18,"email":37},"Annina Lyly, MD, PhD","+358 50 4287952","annina.lyly@hus.fi",[39],{"facility":40,"status":41,"city":42,"state":18,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Helsinki University Hospital","RECRUITING","Helsinki","00250","Finland","FI",{"type":47,"coordinates":48},"Point",[49,50],24.93545,60.16952,{"lat":50,"lon":49},[53,54],{"name":30,"role":31,"phone":32,"phoneExt":18,"email":33},{"name":35,"role":31,"phone":36,"phoneExt":18,"email":37},{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Hanna Hisinger-Mölkänen","Principal Investigator, Head of department","100641729","execise-intervention-in-adult-severe-asthma-100641729",false,"NCT07655037","Execise Intervention in Adult Severe Asthma","Exercise Intervention in Severe Asthma: a Randomized Controlled Trial in Adults on Biological Treatment for Asthma","Inclusion Criteria:\n\n* Age over 18 years\n* 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\n\nExclusion Criteria:\n\n* Upcoming major surgery\n* Acute musculoskeletal disease which unables regular exercise\n* Inability to commit to the appointments and the exercise plan due to exhaustion or fatigue\n* Pregnancy","ALL","18 Years",{"count":69,"type":70},60,"ESTIMATED","INTERVENTIONAL",[73],"NA","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.\n\nThe 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.\n\nThe primary outcome is the change in exercise tolerance, measured as peak oxygen uptake during cardiopulmonary exercise testing.\n\nSecondary 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).\n\nAt 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.\n\nFitness assessments are repeated at 6 months for all participants, and asthma control is evaluated at 6 and 12 months",[76,77],"Severe Asthma","Asthma",[79,80],"severe asthma","biological treatment","2026-06-15",{"date":83,"type":84},"2026-06-17","ACTUAL",{"date":86,"type":84},"2026-03-18",{"date":88,"type":70},"2028-10",{"name":5,"class":6},1]