[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555517":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":38,"centralContacts":42,"locations":29,"responsibleParty":52,"collaborators":54,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":29,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":83,"whyStopped":29,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":29},{"fullName":5,"class":6},"University of Southampton","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Multimodal Intervention (Exercise, breathing retraining nutritional and behaviour change support)","EXPERIMENTAL","Participants with difficult asthma and multimorbidity (more than 2 additional long term health conditions alongside asthma) will be invited to take part in the study. Participants will undertake in a 6-month\u002F 24 week supervised multimodal health improvement programme (combining exercise training, behavioural change support, breathing retraining and dietary and emotional self-management support. This programme will run alongside usual treatment.\n\nParticipants will be asked to undergo some additional exercise-based tests, activity monitoring, assessment of nutritional wellbeing and complete some questionnaires before, after and during the intervention, with a total of 3 face to face study visits and 2 virtual visits at University Hospital Southampton.",[13,14,15,16],"Behavioral: Behaviour change","Behavioral: Dietary support","Behavioral: Breathing pattern retraining","Behavioral: Exercise training",[18,25,30,34],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"BEHAVIORAL","Behaviour change","healthy conversations to support behaviour change",[9],[24],"healthy conversations",{"type":19,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"Dietary support","Guidance on healthy eating",[9],null,{"type":19,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Breathing pattern retraining","guidance on breathing pattern in exercise",[9],{"type":19,"name":35,"description":36,"armGroupLabels":37,"otherNames":29},"Exercise training","Exercise intervention prescribed to participant fitness level",[9],[39],{"name":40,"affiliation":5,"role":41},"Anna Freeman, MBBS PhD","PRINCIPAL_INVESTIGATOR",[43,49],{"name":44,"role":45,"phone":46,"phoneExt":47,"email":48},"Anna Freeman, PhD MBBS","CONTACT","0238120 5232","6397","a.freeman@soton.ac.uk",{"name":50,"role":45,"phone":46,"phoneExt":29,"email":51},"Ramesh Kurukulaaratchy, MBBS MD","R.J.Kurukulaaratchy@soton.ac.uk",{"type":53,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR",[55],{"name":56,"class":6},"University Hospital Southampton NHS Foundation Trust","100555517","living-better-with-asthma-study-a-multimodal-intervention-to-address-multimorbidity-in-difficult-asthma-100555517",false,"NCT06513117","LIving BEtteR With asThma studY:: A Multimodal Intervention to Address Multimorbidity in Difficult Asthma","LIving BEtteR With asThma studY: A Multimodal Intervention to Address Multimorbidity in Difficult Asthma","LIBERTY","Inclusion Criteria:\n\nAged 18 to 80 years Able and willing to give informed consent Diagnosis of asthma determined by\n\n1. clinical diagnosis of difficult asthma as defined by BTS steps 4-5 and\n2. enrolled in WATCH or meet WATCH inclusion criteria.\n3. Demonstration of suboptimal symptom control through an ACQ ≥ 1.5 at enrolment\n4. Normal lung function or mild\u002Fmoderate airflow obstruction at baseline (FEV1\\>50% predicted)\n5. Not achieving WHO recommendations for physical activity for people living with chronic health conditions(62) (150-300 minutes of moderate-intensity aerobic physical activity; or at least 75-150 minutes of vigorous-intensity aerobic physical activity; or an equivalent combination of moderate- and vigorous-intensity activity throughout the week) 6)12 lead ECG without clinically significant abnormality -\n\nExclusion Criteria:\n\n1. Intercurrent exacerbation or exacerbation within 4 weeks prior to enrolment in study requiring treatment with oral corticosteroids and\u002For antibiotics. Note participants can be rescreened 4 weeks post exacerbation if they had not commenced the study\n2. Initiation of biologic treatment within 6 months prior to recruitment or during study participation\n3. Investigator determined significant change in regular asthma medication in the 12 weeks preceding or during trial period\n4. Other medical or psychiatric conditions (including cognitive decline) limiting ability to exercise or that may in the opinion of the study clinician carry inherent risk for exercise\n5. Contraindication to ISWT\n6. Positive pregnancy test\n7. Beta blocker treatment (due to impact on exercise prescription using HR) -","ALL","18 Years","80 Years",{"count":69,"type":70},30,"ESTIMATED","INTERVENTIONAL",[73],"NA","Multimorbidity is a significant issue for many patients with difficult asthma. With patients, we have co-designed a multimodal intervention comprising prescribed exercise, dietary support, breathing pattern retraining and behaviour change to target multimorbidity in difficult asthma",[76,77],"Asthma","Multi Morbidity",[79,80,81,82],"exercise","behaviour change","multimorbidity","asthma","NOT_YET_RECRUITING","2024-07-24",{"date":86,"type":87},"2024-07-26","ACTUAL",{"date":89,"type":70},"2024-10",{"date":91,"type":70},"2028-04",{"name":5,"class":6}]