[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657573":3},{"organization":4,"outcomesModule":7,"designInfo":57,"detailedDescription":67,"studyPopulation":60,"armGroups":68,"interventions":81,"overallOfficials":91,"centralContacts":108,"locations":116,"responsibleParty":159,"collaborators":161,"id":169,"slug":170,"hasResults":171,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":171,"sex":177,"minAge":178,"maxAge":60,"enrollmentInfo":179,"targetDuration":60,"studyType":182,"phases":183,"briefSummary":185,"conditions":186,"keywords":188,"overallStatus":194,"whyStopped":60,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":204},{"fullName":5,"class":6},"University of Aarhus","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":44},[9],{"measure":10,"description":11,"timeFrame":12},"Change from baseline to 6 months in health-related quality of life measured by the EuroQol 5-dimension 5-Level (EQ-5D-5L).","The EQ-5D-5L is a five-dimension, patient-reported outcome measure designed to assess generic health-related quality of life. The descriptive index ranges from -0.757 (worst health state) to 1.000 (best health state), while the EQ visual analogue scale (EQ-VAS) ranges from 0 (worst imaginable health) to 100 (best imaginable health).","Measured at baseline, 6 months, and 12 months.",[14,18,21,25,28,31,34,37,41],{"measure":15,"description":16,"timeFrame":17},"Change from baseline in functional performance measured by the 30-second sit-to-stand test (number of repetitions).","The 30-second sit-to-stand test assesses lower-extremity functional performance. Participants are instructed to stand up from and sit down on a standard chair as many times as possible within 30 seconds without using their arms. The outcome is the total number of completed repetitions, with higher scores indicating better functional performance.","Measured at baseline and 6 months",{"measure":19,"description":20,"timeFrame":17},"Change from baseline in aerobic capacity measured by the 2-minute walk test.","The 2-minute walk test assesses aerobic capacity and functional walking performance. Participants are instructed to walk as far as possible for 2 minutes along a course of up to 30 metres. The outcome is the total distance walked in metres, with greater distances indicating better aerobic capacity and functional performance.",{"measure":22,"description":23,"timeFrame":24},"Change from baseline in upper-body functional strength measured by the 30-second arm curl test (number of repetitions).","The 30-second arm curl test assesses upper-body functional strength. Participants are instructed to perform as many arm curl repetitions as possible within 30 seconds while seated, using their dominant arm and a standardized weight (2 kg for women and 4 kg for men). The outcome is the total number of completed repetitions, with higher scores indicating better upper-body functional strength.","Measured at baseline and 6 months.",{"measure":26,"description":27,"timeFrame":24},"Change from baseline in balance measured by the Mini Balance Evaluation Systems Test (Mini-BESTest).","The Mini-BESTest assesses dynamic balance and postural control. The test consists of 14 tasks covering anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. Each task is scored from 0 to 2, resulting in a total score ranging from 0 to 28 points, with higher scores indicating better dynamic balance and postural control.",{"measure":29,"description":30,"timeFrame":12},"Change from baseline in disease impact measured by the Systemic Sclerosis Impact of Disease (ScleroID).","The Systemic Sclerosis Impact of Disease (ScleroID) is a patient-reported outcome measure designed to assess the impact of systemic sclerosis on patients' daily lives. It comprises 10 domains covering Raynaud's phenomenon, hand function, upper and lower gastrointestinal symptoms, pain, fatigue, life, body mobility, breathlessness, and digital ulcers. Item scores are combined using validated domain-specific weights to generate a total score ranging from 0 to 10, with higher scores indicating greater disease impact.",{"measure":32,"description":33,"timeFrame":12},"Change from baseline in physical activity level measured by the International Physical Activity Questionnaire - Short Form (IPAQ-SF).","The International Physical Activity Questionnaire - Short Form (IPAQ-SF) is a patient-reported questionnaire that assesses physical activity performed during the previous 7 days. It records time spent in vigorous-intensity activity, moderate-intensity activity, walking, and sedentary behaviour. Responses are used to calculate physical activity as metabolic equivalent (MET)-minutes per week and to classify participants into low, moderate, or high physical activity categories according to the IPAQ scoring protocol. Higher MET-minutes per week and higher physical activity categories indicate greater levels of physical activity.",{"measure":35,"description":36,"timeFrame":12},"Change from baseline in depressive symptoms measured by the Major Depression Inventory (MDI).","The Major Depression Inventory (MDI) is a patient-reported questionnaire designed to assess depressive symptoms experienced during the previous 2 weeks. The questionnaire consists of 10 items scored on a 6-point scale, resulting in a total score ranging from 0 to 50. Higher scores indicate more severe depressive symptoms.",{"measure":38,"description":39,"timeFrame":40},"Productivity losses measured by the iMTA Productivity Cost Questionnaire (iPCQ).","The iMTA Productivity Cost Questionnaire (iPCQ) is a patient-reported questionnaire that assesses productivity losses due to health problems. It includes three modules measuring productivity losses related to absenteeism (absence from paid work), presenteeism (reduced productivity while at work), and unpaid work. Higher productivity losses indicate a greater impact of health problems on work and daily activities.","Measured at baseline and at 3, 6, 9, and 12 months.",{"measure":42,"description":43,"timeFrame":40},"Healthcare utilization and medication use measured by the Healthcare Utilization Questionnaire (HUQ).","The Healthcare Utilization Questionnaire (HUQ) is a patient-reported questionnaire designed to assess healthcare utilization and medication use. It collects information on contacts with healthcare providers, hospital services, and prescribed and over-the-counter medication use during the recall period. The questionnaire is used to estimate healthcare resource use for the health economic evaluation.",[45,49,53],{"measure":46,"description":47,"timeFrame":48},"Number of participants experiencing adverse events (AEs) and serious adverse events (SAEs).","Adverse events (AEs) and serious adverse events (SAEs) will be monitored throughout the study. During the intervention period, physiotherapists supervising the exercise programme will record any reported or observed AEs and SAEs. In addition, participants will be asked about any AEs and SAEs at the 6- and 12-month follow-up assessments using open-ended questions.","Registered continuously during the 24-week intervention and at 6- and 12-month follow-up.",{"measure":50,"description":51,"timeFrame":52},"Adherence to the 24-week partially supervised, home-based exercise programme.","Adherence will be assessed using participants' exercise diaries. The number of completed exercise sessions will be divided by the number of planned exercise sessions and multiplied by 100 to calculate adherence as a percentage. An exercise session is considered completed when the participant performs at least 10 minutes of walking and at least one set of each resistance exercise. High adherence is defined as completion of at least 70% of the 72 planned exercise sessions during the 24-week intervention period.","Registered by the participants throughout the 24-week intervention period.",{"measure":54,"description":55,"timeFrame":56},"Number of participants who withdraw from the study (drop-outs).","The number and proportion of participants who withdraw from the study before completing the 12-month follow-up will be recorded. Reasons for withdrawal will be documented when available.","Registered from randomisation to the 12-month follow-up.",{"allocation":58,"interventionModel":59,"interventionModelDescription":60,"primaryPurpose":61,"observationalModel":60,"timePerspective":60,"maskingInfo":62},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":63,"maskingDescription":64,"whoMasked":65},"SINGLE","Outcome assessors are blinded to treatment allocation. Participants are instructed not to disclose their treatment allocation to the outcome assessor during testing.",[66],"OUTCOMES_ASSESSOR","Systemic sclerosis (SSc) is a rare autoimmune connective tissue disease associated with substantial impairments in health-related quality of life, physical function, and participation in daily activities. Although exercise is recommended as part of the non-pharmacological management of SSc, the current evidence is based primarily on small, short-term studies, and high-quality randomized controlled trials evaluating the effectiveness and cost-effectiveness of home-based exercise programmes are lacking.\n\nThe ScleroStrong trial is an international, multicentre, assessor-blinded, parallel-group randomised controlled trial conducted at Aarhus University Hospital, Odense University Hospital, Copenhagen University Hospital - Rigshospitalet, and the University Hospital of Pisa. A total of 270 adults with systemic sclerosis will be randomised (1:1) to either a partially supervised, home-based exercise programme in addition to usual care or to usual care alone. Clinical effectiveness will be evaluated at 6 months, while the health economic evaluation will be performed over a 12-month follow-up period.\n\nThe primary objective is to determine whether a partially supervised, home-based exercise programme improves health-related quality of life compared with usual care. A secondary objective is to evaluate whether the intervention represents a cost-effective treatment strategy from both societal and healthcare perspectives. The study will additionally investigate the effects of the intervention on disease impact, physical function, physical activity, depressive symptoms, adherence, and safety.\n\nThe investigators hypothesize that:\n\n* A partially supervised, home-based exercise programme will result in greater improvements in health-related quality of life after 6 months compared with usual care.\n* The partially supervised, home-based exercise programme will be cost-effective and cost-utility favourable compared with usual care over a 12-month follow-up period.\n* Participants allocated to the partially supervised, home-based exercise programme will demonstrate greater improvements in disease impact, physical function, and physical activity than participants receiving usual care.\n\nA full trial protocol including a statistical analysis plan will be published and made publicly available before completion of the primary analyses. The primary analysis will follow the intention-to-treat principle, with a supplementary per-protocol analysis. Between-group differences will be analysed using mixed-effects regression models including intervention group, follow-up time, and their interaction as fixed effects, while recruitment site and participant will be included as random effects. Cost-effectiveness and cost-utility analyses will estimate incremental cost-effectiveness ratios (ICERs) and incremental cost-utility ratios (ICURs) based on healthcare and societal costs and quality-adjusted life years.",[69,75],{"label":70,"type":71,"description":72,"interventionNames":73},"Partially supervised home-based exercise","EXPERIMENTAL","Participants allocated to this arm will receive a 24-week, partially supervised home-based exercise programme in addition to usual care, followed by 28 weeks of self-guided exercise. The programme consists of three weekly exercise sessions including 30 minutes of moderate-intensity walking and three resistance exercises (squat, elastic-band chest press, and elastic-band seated row). Participants will attend six online physiotherapist consultations during the first 24 weeks for exercise instruction, monitoring, progression, and individual adaptation. Exercise progression is based on participants' ability to perform three sets of 10-12 repetitions with acceptable pain and discomfort. Participants will receive instructional videos, exercise equipment (elastic resistance bands), and an exercise diary. The intervention is individually tailored according to disease manifestations, physical function, and exercise tolerance while continuing their usual care.",[74],"Behavioral: Home-based exercise programme",{"label":76,"type":77,"description":78,"interventionNames":79},"Usual care","ACTIVE_COMPARATOR","Participants allocated to the usual care group will continue to receive the standard care provided by their healthcare providers. Usual care may include pharmacological treatment, routine outpatient follow-up, and access to publicly funded group-based physiotherapy according to national practice. The content and extent of usual care may vary between participants depending on disease manifestations and clinical needs. Participants will continue their current treatments and may receive additional treatments if considered appropriate by their treating healthcare providers.",[80],"Other: Usual Care",[82,87],{"type":83,"name":84,"description":85,"armGroupLabels":86,"otherNames":60},"BEHAVIORAL","Home-based exercise programme","The intervention is a 24-week, partially supervised home-based exercise programme consisting of three exercise sessions per week, followed by 28 weeks of self-guided exercise. Each session includes 30 minutes of moderate-intensity walking (Borg Rating of Perceived Exertion 14-15) and three progressive resistance exercises targeting major muscle groups (squat, elastic-band chest press, and elastic-band seated row). Resistance exercises are performed in three sets of 10-12 repetitions and individually progressed by increasing resistance or exercise difficulty according to predefined progression criteria. The programme includes six online physiotherapist consultations during the supervised phase. Instructional exercise videos, elastic resistance bands, and an exercise diary are provided to support the home-based exercise programme. The programme is individually tailored according to disease manifestations, physical function, and exercise tolerance.",[70],{"type":6,"name":88,"description":89,"armGroupLabels":90,"otherNames":60},"Usual Care","Usual care consists of standard clinical management provided by the participant's healthcare providers according to local practice and current national recommendations. This may include pharmacological treatment, routine outpatient follow-up, patient education, and referral to publicly funded group-based physiotherapy where appropriate. The content and intensity of usual care are individualized according to disease manifestations, symptoms, and clinical needs and are not standardized by the study protocol.",[76],[92,96,100,102,105],{"name":93,"affiliation":94,"role":95},"Jesper L Jensen, MSc","Aarhus University Hospital","PRINCIPAL_INVESTIGATOR",{"name":97,"affiliation":98,"role":99},"Inger Mechlenburg, Professor","Aarhus University Hospital and Aarhus University","STUDY_DIRECTOR",{"name":101,"affiliation":98,"role":99},"Esben U Næser, Clin. Ass. Prof.",{"name":103,"affiliation":104,"role":99},"John K Brincks, Senior Ass. Prof.","VIA University College",{"name":106,"affiliation":107,"role":99},"Marco Di Battista","Pisa University Hospital",[109,113],{"name":93,"role":110,"phone":111,"phoneExt":60,"email":112},"CONTACT","+4560608684","jesperjensen@clin.au.dk",{"name":97,"role":110,"phone":114,"phoneExt":60,"email":115},"+4521679062","inger.mechlenburg@clin.au.dk",[117,133,147],{"facility":118,"status":60,"city":119,"state":60,"zip":120,"country":121,"countryCode":122,"cosmosGeoPoint":123,"geoPoint":128,"contacts":129},"Department of Clinical Medicine - The Section for Rheumatology, Aarhus University Hospital","Aarhus","8000","Denmark","DK",{"type":124,"coordinates":125},"Point",[126,127],10.21076,56.15674,{"lat":127,"lon":126},[130],{"name":131,"role":110,"phone":60,"phoneExt":60,"email":132},"Esben U Næser, Clin. Ass. Prof","esben.naeser@clin.au.dk",{"facility":134,"status":60,"city":135,"state":60,"zip":136,"country":121,"countryCode":122,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"Department for Rheumatology and Spine Diseases, Copenhagen University Hospital - Rigshospitalet","Glostrup Municipality","2600",{"type":124,"coordinates":138},[139,140],12.40377,55.6666,{"lat":140,"lon":139},[143],{"name":144,"role":110,"phone":145,"phoneExt":60,"email":146},"Christoffer T Nielsen, Clin. Ass. Prof","+4535458244","christoffer.tandrup.nielsen.01@regionh.dk",{"facility":148,"status":60,"city":149,"state":60,"zip":150,"country":121,"countryCode":122,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"Department of Rheumatology, Odense University Hospital","Odense","5000",{"type":124,"coordinates":152},[153,154],10.38831,55.39594,{"lat":154,"lon":153},[157],{"name":158,"role":110,"phone":60,"phoneExt":60,"email":60},"Katrine H Gade, MD, Consultant",{"type":160,"investigatorFullName":60,"investigatorTitle":60,"investigatorAffiliation":60,"oldNameTitle":60,"oldOrganization":60},"SPONSOR",[162,163,165,167],{"name":94,"class":6},{"name":164,"class":6},"Odense University Hospital",{"name":166,"class":6},"Rigshospitalet, Denmark",{"name":107,"class":168},"UNKNOWN","100657573","home-based-exercise-for-improving-health-related-quality-of-life-in-systemic-sclerosis-100657573",false,"NCT07840430","Home-based Exercise for Improving Health-related Quality of Life in Systemic Sclerosis","Home-based Exercise Compared to Usual Care for Improving Health-related Quality of Life in Systemic Sclerosis - a Multicentre Randomised Controlled Trial (the ScleroStrong Trial)","ScleroStrong","Inclusion Criteria:\n\n* Adults 18 years and older\n* Confirmed SSc diagnosis (ACR\u002FEULAR criteria) for ≥6 months\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Evidence that the patient cannot participate in a self-guided exercise programme or adhere to study procedures (e.g. due to cognitive impairment)\n* Patient cannot understand or speak Danish (for Aarhus University Hospital, Odense University Hospital, and Copenhagen University Hospital - Rigshospitalet) or Italian (for University Hospital of Pisa).\n* Patient lacks an email address to receive electronic questionnaires.","ALL","18 Years",{"count":180,"type":181},270,"ESTIMATED","INTERVENTIONAL",[184],"NA","The goal of this randomised controlled trial is to evaluate whether a partially supervised, home-based exercise programme in addition to usual care improves health-related quality of life in adults with systemic sclerosis.\n\nThe main questions it aims to answer are:\n\n1. Does a partially supervised, home-based exercise programme improve health-related quality of life, measured by the EQ-5D-5L, compared with usual care alone after 6 months?\n2. Is the partially supervised, home-based exercise programme cost-effective compared with usual care over a 12-month period?\n\nResearchers will compare the partially supervised, home-based exercise programme plus usual care with usual care alone to determine whether the partially supervised, home-based exercise programme improves health-related quality of life, disease impact, physical function, physical activity, and represents a cost-effective treatment strategy.\n\nParticipants will:\n\n* Be randomly assigned to either the partially supervised, home-based exercise programme plus usual care or usual care alone.\n* Complete questionnaires at baseline and after 3, 6, 9, and 12 months.\n* Undergo physical function assessments at baseline and after 6 months.\n* If allocated to the intervention group, perform a 24-week home-based exercise programme consisting of three weekly sessions of aerobic and resistance exercise, supported by six online physiotherapist consultations, followed by 28 weeks of self-guided exercise.\n* Complete follow-up assessments of healthcare utilization, productivity, adherence, and adverse events throughout the 12-month study period.",[187],"Systemic Sclerosis (SSc)",[189,190,191,192,193],"Systemic Sclerosis","SSc","Exercise Therapy","Health economic evaluation","Scleroderma","NOT_YET_RECRUITING","2026-09-18",{"date":197,"type":198},"2026-09-25","ACTUAL",{"date":200,"type":181},"2026-10-15",{"date":202,"type":181},"2029-09-30",{"name":5,"class":6},3]