[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053337":3},{"organization":4,"outcomesModule":7,"designInfo":67,"detailedDescription":72,"studyPopulation":66,"armGroups":73,"interventions":84,"overallOfficials":90,"centralContacts":94,"locations":102,"responsibleParty":119,"collaborators":66,"id":121,"slug":66,"hasResults":122,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":66,"eligibilityCriteria":126,"healthyVolunteers":122,"sex":127,"minAge":128,"maxAge":66,"enrollmentInfo":129,"targetDuration":66,"studyType":132,"phases":133,"briefSummary":135,"conditions":136,"keywords":138,"overallStatus":146,"whyStopped":66,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},{"fullName":5,"class":6},"Sheffield Hallam University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":32,"otherOutcomes":66},[9,13,17,21,25,28],{"measure":10,"description":11,"timeFrame":12},"Recruitment rate","Proportion of eligible participants who consent to take part, expressed as a monthly recruitment rate.","From study start through completion of recruitment, up to 12 months",{"measure":14,"description":15,"timeFrame":16},"Retention rate","Proportion of randomised participants completing the 12-week intervention (progression target ≥80%)","12 weeks",{"measure":18,"description":19,"timeFrame":20},"Adherence","Proportion of prescribed exercise sessions completed (target ≥60%), assessed by session completion records and device-based monitoring (step count and heart rate via ActiGraph accelerometer","Over the 12-week intervention period",{"measure":22,"description":23,"timeFrame":24},"Data completeness","Proportion of participants completing outcome measures at baseline and 12 weeks (target ≥75%)","Baseline and 12 weeks",{"measure":26,"description":27,"timeFrame":16},"Acceptability","Acceptability assessed via a questionnaire informed by the Theoretical Framework of Acceptability (seven constructs, 5-point Likert scale), supplemented by post-intervention interviews",{"measure":29,"description":30,"timeFrame":31},"Adverse events and serious adverse events","Number, type and severity of adverse events and serious adverse events, reviewed by the independent Data Safety Committee.","Throughout the 12-week intervention period",[33,36,39,42,45,48,51,54,57,60,63],{"measure":34,"description":35,"timeFrame":24},"Fatigue","FACIT-Fatigue Scale (Functional Assessment of Chronic Illness Therapy - Fatigue); score range 0-52; higher scores indicate less fatigue (better outcome)",{"measure":37,"description":38,"timeFrame":24},"Anxiety and depression","Hospital Anxiety and Depression Scale (HADS); two subscales (anxiety and depression), each scored 0-21; higher scores indicate greater symptom severity (worse outcome)",{"measure":40,"description":41,"timeFrame":24},"Health-related quality of life","EQ-5D-5L; index value ranging from below 0 to 1, where 1 = full health and higher = better; includes a 0-100 visual analogue scale (higher = better health)",{"measure":43,"description":44,"timeFrame":24},"Physical activity","International Physical Activity Questionnaire - Short Form; reported as MET-minutes per week; higher values indicate greater physical activity",{"measure":46,"description":47,"timeFrame":24},"Lower-limb strength and endurance","30-Second Sit-to-Stand Test; number of full sit-to-stand repetitions completed in 30 seconds; higher counts indicate better lower-limb strength and endurance (better outcome)",{"measure":49,"description":50,"timeFrame":24},"Sub-maximal aerobic capacity","2-Minute Step Test; total number of steps completed in 2 minutes; higher counts indicate better aerobic capacity (better outcome).",{"measure":52,"description":53,"timeFrame":24},"Muscle strength","Hand grip strength via Jamar handheld dynamometer, recorded in kilograms (best of three attempts per hand); higher values indicate greater muscle strength (better outcome)",{"measure":55,"description":56,"timeFrame":24},"Functional mobility","Short Physical Performance Battery (SPPB); composite score 0-12 from balance, 4-metre gait speed, and 5-repetition sit-to-stand; higher scores indicate better lower-extremity function (better outcome)",{"measure":58,"description":59,"timeFrame":24},"Orthostatic heart rate response","Heart rate measured supine and on standing (1, 3, 5 min) to screen for orthostatic intolerance",{"measure":61,"description":62,"timeFrame":24},"Orthostatic blood pressure response","Blood pressure measured supine and on standing (1, 3, 5 min) to screen for orthostatic hypotension.",{"measure":64,"description":65,"timeFrame":24},"Microvascular function","Cutaneous vascular conductance via Laser Speckle Contrast Imaging during local thermal hyperaemia. Expressed as cutaneous vascular conductance (perfusion units\u002FmmHg); higher values indicate greater microvascular reactivity",null,{"allocation":68,"interventionModel":69,"interventionModelDescription":66,"primaryPurpose":6,"observationalModel":66,"timePerspective":66,"maskingInfo":70},"RANDOMIZED","PARALLEL",{"masking":71,"maskingDescription":66,"whoMasked":66},"NONE","This is a mixed-methods feasibility study delivered across four phases. Phase 1 uses qualitative interviews with people with vEDS, family members and clinicians to understand experiences of physical activity and decision-making under uncertain clinical guidance. Phase 2 uses co-production focus groups to design the exercise-based lifestyle intervention. Phase 3 is a 12-week randomised feasibility trial in which adults with vEDS are randomised to the co-produced intervention or to usual care, assessing feasibility outcomes (recruitment, retention, adherence, data completeness, acceptability and safety) and exploratory clinical measures. Phase 4 uses post-intervention interviews to explore participant experiences and refine the intervention. The registered trial corresponds to the Phase 3 randomised feasibility component; the qualitative phases provide the development and evaluation context.",[74,80],{"label":75,"type":76,"description":77,"interventionNames":78},"Intervention","EXPERIMENTAL","Participants receive a 12-week co-produced, remotely supervised, low-intensity and low-impact exercise-based lifestyle intervention, tailored to individual capacity, with weekly remote monitoring.",[79],"Behavioral: Co-designed exercise-based lifestyle intervention",{"label":81,"type":82,"description":83,"interventionNames":66},"Usual Care","NO_INTERVENTION","Participants continue standard NHS medical care and any lifestyle advice from their treating clinicians, with no study intervention.",[85],{"type":86,"name":87,"description":88,"armGroupLabels":89,"otherNames":66},"BEHAVIORAL","Co-designed exercise-based lifestyle intervention","A 12-week individually tailored exercise-based lifestyle programme, co-produced with people with vEDS, delivered remotely with supervision and weekly monitoring. Comprises low-intensity, low-impact aerobic and functional activity progressed to individual capacity, with behavioural support to encourage sustained physical activity.",[75],[91],{"name":92,"affiliation":5,"role":93},"Markos Klonizakis","PRINCIPAL_INVESTIGATOR",[95,100],{"name":96,"role":97,"phone":98,"phoneExt":66,"email":99},"Ian Thistlewood","CONTACT","+447939953194","i.thistlewood@shu.ac.uk",{"name":92,"role":97,"phone":66,"phoneExt":66,"email":101},"m.klonizakis@shu.ac.uk",[103],{"facility":5,"status":66,"city":104,"state":105,"zip":106,"country":107,"countryCode":108,"cosmosGeoPoint":109,"geoPoint":114,"contacts":115},"Sheffield","South Yorkshire","S10 2BP","United Kingdom","UK",{"type":110,"coordinates":111},"Point",[112,113],-1.4659,53.38297,{"lat":113,"lon":112},[116,118],{"name":96,"role":97,"phone":117,"phoneExt":66,"email":99},"07939953194",{"name":92,"role":97,"phone":66,"phoneExt":66,"email":101},{"type":93,"investigatorFullName":92,"investigatorTitle":120,"investigatorAffiliation":5,"oldNameTitle":66,"oldOrganization":66},"Professor","100053337",false,"NCT07697573","An Exercise and Lifestyle Programme for Adults With Vascular Ehlers-Danlos Syndrome: A Feasibility Study","Co-Producing and Piloting an Exercise-Based Lifestyle Intervention for Individuals With Vascular Ehlers-Danlos Syndrome (vEDS): A Mixed-Methods Feasibility Study","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Confirmed diagnosis of vascular Ehlers-Danlos syndrome (vEDS)\n* Living in the UK\n* Able to provide informed consent\n* Medically stable, defined as: no arterial dissection, rupture, or other major vEDS-related vascular event within the preceding 6 months; no recent hospitalisation for vEDS complications; and blood pressure considered controlled by their treating clinician\n* Medical clearance from their treating clinician\n* Not pregnant at the time of enrolment\n\nExclusion Criteria:\n\n* Major vEDS-related vascular event (arterial dissection or rupture) within the previous 6 months\n* Recent hospitalisation for vEDS complications\n* Blood pressure not controlled by treating clinician\n* Pregnancy at enrolment (participants who become pregnant during the intervention are withdrawn from the exercise component but may continue follow-up data collection if they wish)\n* Unable to provide informed consent","ALL","18 Years",{"count":130,"type":131},40,"ESTIMATED","INTERVENTIONAL",[134],"NA","Vascular Ehlers-Danlos syndrome (vEDS) is a rare, life-threatening connective tissue disorder. People with vEDS have often been advised to limit physical activity, yet the safety and feasibility of structured exercise in this group is poorly understood. This study works with people with vEDS, their families and clinicians to co-design a safe, tailored physical activity programme, then tests it in a 12-week randomised feasibility study comparing the programme with usual care. The aim is to find out whether the intervention and the trial procedures are safe, acceptable and practical, in order to inform a future full-scale trial. Outcomes focus on recruitment, retention, adherence, acceptability and safety, alongside exploratory measures of physical function, quality of life and microvascular health.",[137],"Vascular Ehlers Danlos Syndrome",[139,140,141,142,143,144,145],"vEDS","COL3A1","physical activity","exercise","feasibility study","rare disease","connective tissue disorder","NOT_YET_RECRUITING","2026-07-09",{"date":149,"type":150},"2026-07-13","ACTUAL",{"date":152,"type":131},"2027-03-01",{"date":154,"type":131},"2028-03-17",{"name":5,"class":6},1]