[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100499323":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":45,"responsibleParty":63,"collaborators":26,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":26,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":26,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":26,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Halmstad University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"HIIT-intervention group","EXPERIMENTAL","12 weeks of structured high intensity interval training followed by 9 month of self-selected training",[13],"Behavioral: High intensity interval training (HIIT)",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","ACTIVE_COMPARATOR","Continuing with their usual exercise habits during 12 months",[19],"Other: Control group",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","High intensity interval training (HIIT)","2 HIIT sessions\u002Fweek in self-selected activity and type of interval-session with in total 15 minutes interval time (85-90% of MHR) with active rest (50-70% of MHR) between intervals for 12 weeks\n\n1 self-selected session at moderate or high-intensity\u002Fweek for 12 weeks Standardized physical and digital coaching by a physiotherapist",[9],null,{"type":6,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Continuing with exercise as usual during 12 months",[15],[31],{"name":32,"affiliation":33,"role":34},"Haglund, Assoc. prof.","Dept. of Environmental and Biosciences, Halmstad University, Sweden","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Emma Haglund, Assoc. prof.","CONTACT","+46703838848","emma.haglund@hh.se",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},"Åsa Andersson, Prof.","+46 733039625","asa.andersson@hh.se",[46],{"facility":5,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"RECRUITING","Halmstad","Halland County","30118","Sweden","SE",{"type":54,"coordinates":55},"Point",[56,57],12.85676,56.67446,{"lat":57,"lon":56},[60,61],{"name":32,"role":38,"phone":39,"phoneExt":26,"email":40},{"name":62,"role":38,"phone":43,"phoneExt":26,"email":44},"Andersson, Prof.",{"type":34,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Emma Haglund","Associate professor in biomedicine","100499323","high-intensity-training-in-patients-with-spondyloarthritis-a-randomized-controlled-trial-100499323",false,"NCT05781763","High-intensity Training in Patients With Spondyloarthritis: a Randomized Controlled Trial","High-intensity Exercise Based on Self-management With Digital Coaching in Patients With Spondyloarthritis: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Axial SpA (ICD10 diagnosis of M45, M46.0, M46.1, M46.8 and M46.9).\n* Fulfilling recommendations for physical activity\n\nExclusion Criteria:\n\n* Changed TNF and anti-inflammatory medication the previous three months\n* Cardiovascular disease\n* Comorbidities making high-intensity training inappropriate\n* Performing high-intensity interval training on a regular basis","ALL","18 Years","67 Years",{"count":77,"type":78},100,"ESTIMATED","INTERVENTIONAL",[81],"NA","Project summary\n\nBackground: For people diagnosed with a spondyloarthritis (SpA) e.g. ankylosing spondylitis or undifferentiated spondyloarthritis, physical activity and exercise are important components in the self-management. Exercise, in addition to physical and mental symptoms related to the disease can easily feel overwhelming to exercise, and low adherence may result. By studying the effects of high-intensity interval training (HIIT) in comparison with training as usual on physiological, inflammatory, and self-reported disease parameters in patients with SpA, we intend to further investigate the short-term and longitudinal training effects, and refine the knowledge to tailor, coach, and stimulate to self-performed HIIT.\n\nObjective: The purpose of this study is to investigate the short- and long-term effects of high- intensity interval training (HIIT) on physiological, inflammatory, and self-reported health parameters in patients with SpA. The aim is also to study the adherence to physical activity and exercise recommendations.\n\nDesign: A randomized controlled trial (RCT) design. Participants: One hundred adults with a confirmed axial SpA from rheumatology clinics in southern Sweden will be recruited and randomized into two groups, the intervention group and the control group.\n\nIntervention: Three high-intensity training sessions per week for three months, of which two interval sessions, with coaching both from a clinical physiotherapist and digital devices (watch and app) followed by nine months with sporadic coaching. The control group will go on with exercise as usual.\n\nPrimary outcome: Self-reported disease activity, inflammatory biomarkers (acute phase proteins).\n\nSecondary outcomes: Physical fitness (aerobic capacity (VO2max), blood pressure, grep strength), body composition and self-reported physical function, health status, well-being, pain, fatigue, adherence to physical activity and exercise recommendations, and confidence in one's own ability to manage pain, symptoms and high-intensity exercise, and additional serum biomarkers.",[84],"Axial Spondyloarthritis","2023-03-12",{"date":87,"type":88},"2023-03-23","ACTUAL",{"date":90,"type":88},"2022-03-21",{"date":92,"type":78},"2026-12",{"name":5,"class":6},1]