[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100488557":3},{"organization":4,"outcomesModule":7,"designInfo":77,"detailedDescription":87,"studyPopulation":80,"armGroups":88,"interventions":99,"overallOfficials":105,"centralContacts":109,"locations":114,"responsibleParty":250,"collaborators":80,"id":252,"slug":80,"hasResults":253,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":257,"eligibilityCriteria":258,"healthyVolunteers":253,"sex":259,"minAge":260,"maxAge":80,"enrollmentInfo":261,"targetDuration":80,"studyType":264,"phases":265,"briefSummary":267,"conditions":268,"keywords":80,"overallStatus":117,"whyStopped":80,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":279},{"fullName":5,"class":6},"Linkoeping University","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":32},[9],{"measure":10,"description":11,"timeFrame":12},"Sedentary time","Sedentary time measured with activity monitor Actigraph","3 months",[14,18,21,24,27,30],{"measure":15,"description":16,"timeFrame":17},"Exercise Capacity","6-minute walk test","Baseline, 3 months and 6 months",{"measure":19,"description":20,"timeFrame":17},"Frailty","Fried Frailty tests",{"measure":22,"description":23,"timeFrame":17},"Clinical frailty","Clinical Frailty Scale: a frailty score ranging from 1 (very fit) to 9 (terminally ill)",{"measure":25,"description":26,"timeFrame":17},"Heart Failure specific Quality of Life","12 item Kansas City Cardiomyopathy includes that quantifies physical limitations, symptom frequency, Quality of Life, and social limitation, along with a summary scores for each domain, scoring from 0 to 100. Zero denoting the worst and 100 the best possible health status.",{"measure":28,"description":29,"timeFrame":17},"General Quality of Life","EuroQol-5 Dimension 5 levels (EQ-5D) includes five domain scales (mobility, self-care, usual activities, pain and discomfort, and anxiety and depression) and five levels for each domain. A higher score in the EQ-5D-5L indicated better HRQOL",{"measure":10,"description":11,"timeFrame":31},"6 months",[33,37,40,43,46,50,54,57,60,63,66,70,73],{"measure":34,"description":35,"timeFrame":36},"Patient expectations","Open ended interview questions","Baseline and 6 months",{"measure":38,"description":39,"timeFrame":17},"Exercise motivation","The situational motivation scale (SIMS): 16 items measuring four forms of motivation with exh four items (amotivation, external, identified, and intrinsic motivation). Each item is rated on a 7-point Likert scale ranging from 1 \"corresponds not at all\" to 7 \"corresponds exactly.\" The score of each form of motivation ranges from 4-28, with a higher score meaning higher motivation.",{"measure":41,"description":42,"timeFrame":31},"Cost","Cost logbook",{"measure":44,"description":45,"timeFrame":31},"Willingness to pay","Interviews",{"measure":47,"description":48,"timeFrame":49},"Time exergaming","Record time exergaming","During the 6 months intervention",{"measure":51,"description":52,"timeFrame":53},"Enjoyment physical activity","Exergaming Enjoyment Scale, 20 items, scoring ranging from 20-100","3 and 6 months in the intervention group only",{"measure":55,"description":56,"timeFrame":17},"Cognitive function","Montreal Cognitive Assessment (MoCA)",{"measure":58,"description":59,"timeFrame":17},"Social and daily function","Canadian Occupational Performance Measure (COPM)",{"measure":61,"description":62,"timeFrame":17},"Depression","Hospital Anxiety and Depression scale( HADs): two conjoint 7-item subscales, one specifically targeted at anxiety (HADS-A) and one focussing on depression (HADS-D). Raw scores of between 8 and 10 identify mild cases of depression or anxiety, 11-15 moderate cases, and 16 or above, severe cases.",{"measure":64,"description":65,"timeFrame":17},"Self-care","European Self-Care Behavioural Scale (ESCBS): nine statements about HF-specific self-care which have to be rated on a 5-point Likert scale ('completely agree' and 'I don't agree at all').The sum score of range from 9 to 45, with lower scores indicating better self-care.",{"measure":67,"description":68,"timeFrame":69},"Knowledge","Heart Failure Knowledge Scale: 15-item, self-administered questionnaire that covers items concerning HF knowledge in general, knowledge on HF treatment (including diet and fluid restriction) and HF symptoms and symptom recognition. The scale has a minimum score of 0 (no knowledge) and a maximum score of 15 points (optimal knowledge).","Baseline",{"measure":71,"description":72,"timeFrame":69},"Clinical Data","Clinical data from patient journal",{"measure":74,"description":75,"timeFrame":76},"Adverse events","Number of adverse events","Throughout the trial of 6 months",{"allocation":78,"interventionModel":79,"interventionModelDescription":80,"primaryPurpose":81,"observationalModel":80,"timePerspective":80,"maskingInfo":82},"RANDOMIZED","PARALLEL",null,"PREVENTION",{"masking":83,"maskingDescription":80,"whoMasked":84},"DOUBLE",[85,86],"CARE_PROVIDER","INVESTIGATOR","Rationale: Heart failure (HF) is an increasing global health concern with over 20 million patients worldwide. A decrease in sedentary time can have beneficial effects for a growing group of inactive patients with HF. The use of exergames (games to improve physical activity) is promising for people who are home bound and physically inactive. Such a gaming activity should be attractive, tailored to preferences and to capacity.\n\nObjective: To determine the effect of tailored exergaming for inactive patients with HF to reduce their sedentary time, improve their daily physical activity, exercise capacity, decrease frailty and improve health-related quality of life.\n\nStudy design: A pilot study and a multicentre, open-label 1:1 randomised clinical trial with 6 months follow-up.\n\nStudy population: Adult patients with symptomatic HF: n= 20 for the pilot study and n=600 for the main study\n\nIntervention: On a background of standard guideline-directed medical therapy patients will be randomised to tailored activity advice (control) or the Heart-Exergame (Heart-eXg) intervention for a period of 3 months. Patients randomised to the Heart-eXg group will receive an exergame with feedback and tailoring to adapt the exergaming advice. Patients will also be able to play with a person in their own network.\n\nMain study parameters\u002Fendpoints: Primary endpoint is sedentary time (actigraphy). Secondary outcomes are daily physical activity, submaximal exercise capacity, physical frailty, health-related quality of life.\n\nThis study will gain insight into the effects of using an exergame that is easily applicable and affordable. Given the vast growing target population of patients with HF worldwide, and the simplicity of the intervention, potentially millions of patients may benefit from the results of this study.",[89,95],{"label":90,"type":91,"description":92,"interventionNames":93},"Exergame group","EXPERIMENTAL","Patients will be introduced to the exergame and the exergame will be installed following a protocol either by the patients themselves or an instructor of the study.\n\nPatients will be advised to exergame daily based on their activity monitor reading at baseline and based on their current activity level and preferences.\n\nDuring the 3 months of active intervention patients will receive feedback on their activity level and data will also be shared with the coach who will use it to adapt the gaming advice. A clear exergaming goal will be set together by patient and coach. In the first month, they will receive weekly feedback on their performance based on the readings from the activity monitor and the reading from the exergame. In the rest of the active study team the frequency of the contact with the coach will be personalized.",[94],"Other: Heart Farming",{"label":96,"type":97,"description":98,"interventionNames":80},"Control group","NO_INTERVENTION","Patients will receive a protocol-based activity advice (one time) from the HF team (nurse, cardiologist and\u002For physiotherapist) that corresponds to the intervention group in terms of time and effort. Participants in the control group are encouraged to decrease their sedentary behaviour to the same extent as the intervention group, and if possible be physical active 30 minutes for 5 days a week.",[100],{"type":101,"name":102,"description":103,"armGroupLabels":104,"otherNames":80},"OTHER","Heart Farming","Heart Farming is a mobile game. which can be played indoors and outdoors and stimulates players to be physically active. The game is built around a theme (farming) and users are challenged to collect products by being active. The phone will register movements and convert them into points and fruits and vegetables. For the basic playing only 10 minutes walking a day with the game is possible and is rewarded. For players who want more challenge and level of trading products and collecting products in groups is added. The game is adaptable to different levels of mobility and players can invite others to play with them. Players can see their own game results, progression, and active time.",[90],[106],{"name":107,"affiliation":5,"role":108},"Tiny Jaarsma, PhD","PRINCIPAL_INVESTIGATOR",[110],{"name":107,"role":111,"phone":112,"phoneExt":80,"email":113},"CONTACT","+46011363550","tiny.jaarsma@liu.se",[115,132,146,159,169,175,186,198,211,220,230,242],{"facility":116,"status":117,"city":118,"state":80,"zip":80,"country":119,"countryCode":120,"cosmosGeoPoint":121,"geoPoint":126,"contacts":127},"Universidade do Porto Faculdade de Medicina","RECRUITING","Porto","Portugal","PT",{"type":122,"coordinates":123},"Point",[124,125],-8.61097,41.1485,{"lat":125,"lon":124},[128],{"name":129,"role":111,"phone":130,"phoneExt":80,"email":131},"Bruno Delgado, PhD","+46700896360","heartexg@hmv.liu.se",{"facility":133,"status":117,"city":134,"state":80,"zip":80,"country":135,"countryCode":136,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"P. J. Safarik University","Košice","Slovakia","SK",{"type":122,"coordinates":138},[139,140],21.25802,48.71441,{"lat":140,"lon":139},[143],{"name":144,"role":111,"phone":130,"phoneExt":80,"email":145},"Aurel Zelko, PhD","aurel.zelko@upjs.sk",{"facility":147,"status":117,"city":148,"state":80,"zip":80,"country":149,"countryCode":150,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"Germans Trias i Pujol Hospital","Barcelona","Spain","ES",{"type":122,"coordinates":152},[153,154],2.15899,41.38879,{"lat":154,"lon":153},[157],{"name":158,"role":111,"phone":130,"phoneExt":80,"email":131},"Beatriz Gonzalez Fernandez",{"facility":160,"status":117,"city":148,"state":80,"zip":80,"country":149,"countryCode":150,"cosmosGeoPoint":161,"geoPoint":163,"contacts":164},"Hospital de Bellvitge",{"type":122,"coordinates":162},[153,154],{"lat":154,"lon":153},[165],{"name":166,"role":111,"phone":167,"phoneExt":80,"email":168},"Sílvia Ibáñez Caballero, MSc","+34606380491","sibanez@bellvitgehospital.cat",{"facility":170,"status":171,"city":148,"state":80,"zip":80,"country":149,"countryCode":150,"cosmosGeoPoint":172,"geoPoint":174,"contacts":80},"Hospital del Mar","ACTIVE_NOT_RECRUITING",{"type":122,"coordinates":173},[153,154],{"lat":154,"lon":153},{"facility":176,"status":117,"city":177,"state":80,"zip":80,"country":149,"countryCode":150,"cosmosGeoPoint":178,"geoPoint":182,"contacts":183},"Xarxa Assistencial Universitaria","Manresa",{"type":122,"coordinates":179},[180,181],1.82399,41.72815,{"lat":181,"lon":180},[184],{"name":185,"role":111,"phone":130,"phoneExt":80,"email":131},"Nuria Santaularia",{"facility":187,"status":117,"city":188,"state":80,"zip":80,"country":149,"countryCode":150,"cosmosGeoPoint":189,"geoPoint":193,"contacts":194},"INCLIVA","Valencia",{"type":122,"coordinates":190},[191,192],-0.37966,39.47391,{"lat":192,"lon":191},[195],{"name":196,"role":111,"phone":167,"phoneExt":80,"email":197},"Patricia Palau, PhD","patripalau@gmail.com",{"facility":199,"status":117,"city":200,"state":80,"zip":80,"country":201,"countryCode":202,"cosmosGeoPoint":203,"geoPoint":207,"contacts":208},"Jönköping Hospital Rydhov","Jönköping","Sweden","SE",{"type":122,"coordinates":204},[205,206],14.15618,57.78145,{"lat":206,"lon":205},[209],{"name":210,"role":111,"phone":80,"phoneExt":80,"email":80},"Tiny Jaarsma",{"facility":212,"status":213,"city":214,"state":80,"zip":80,"country":201,"countryCode":202,"cosmosGeoPoint":215,"geoPoint":219,"contacts":80},"Kalmar Länssjukhuset","TERMINATED","Kalmar",{"type":122,"coordinates":216},[217,218],16.36163,56.66157,{"lat":218,"lon":217},{"facility":221,"status":117,"city":222,"state":80,"zip":80,"country":201,"countryCode":202,"cosmosGeoPoint":223,"geoPoint":227,"contacts":228},"Linköping University Hospital","Linköping",{"type":122,"coordinates":224},[225,226],15.62157,58.41086,{"lat":226,"lon":225},[229],{"name":210,"role":111,"phone":80,"phoneExt":80,"email":80},{"facility":231,"status":117,"city":232,"state":80,"zip":233,"country":201,"countryCode":202,"cosmosGeoPoint":234,"geoPoint":238,"contacts":239},"Primary Health Care Centers Östergötland","Norrköping","60591",{"type":122,"coordinates":235},[236,237],16.1826,58.59419,{"lat":237,"lon":236},[240],{"name":241,"role":111,"phone":130,"phoneExt":80,"email":131},"Leonie Klompstra, PhD",{"facility":243,"status":117,"city":232,"state":80,"zip":80,"country":201,"countryCode":202,"cosmosGeoPoint":244,"geoPoint":246,"contacts":247},"Vrinnevisjukhuset",{"type":122,"coordinates":245},[236,237],{"lat":237,"lon":236},[248],{"name":249,"role":111,"phone":130,"phoneExt":80,"email":131},"Laila Hübbert, PhD",{"type":108,"investigatorFullName":210,"investigatorTitle":251,"investigatorAffiliation":5,"oldNameTitle":80,"oldOrganization":80},"Professor","100488557",false,"NCT05641662","Effects of Exergaming to Reduce Sedentary Time in Inactive Patients With Heart Failure","Heart-eXg Study: Effects of Exergaming to Reduce Sedentary Time in Inactive Patients With Heart Failure: An International Multi-center, Randomized, Parallel-group Study","Heart-eXg","Inclusion Criteria:\n\n1. Diagnosed with symptomatic HF (NYHA II-IV) as diagnosed by cardiologist, (independent of Ejection Fraction: Patients with a preserved ejection fraction (HFpEF), mid-range ejection fraction (HFmrREF) or reduced ejection fraction (HFrEF) can be included.\n2. Clinically stable\n3. Physically inactive\n4. Older than 18 years, there is no upper age limit,\n5. Speak\u002Funderstand the language of the country where the study is taking place.\n6. Wanting to use a smartphone for the study (if patients do not have a smartphone, they can borrow it from the study team for the duration of the study)\n\nExclusion Criteria:\n\n1. Unable to use an exergame due to visual, hearing, cognitive impairment assessed by HF nurse or cardiologist.\n2. Not being able to perform the 6-minute walk test.\n3. Not being able or willing to wear an activity monitor.\n4. Currently included in a rehabilitation program\n5. Lack of willingness to play an exergame.\n6. Co-morbidity that hinders benefitting for this form of exercise (history of stroke, severe cognitive dysfunction, or a life expectancy shorter than 6 months).","ALL","18 Years",{"count":262,"type":263},750,"ESTIMATED","INTERVENTIONAL",[266],"NA","The goal of this to determine the effect of tailored exergaming for inactive patients with heart failure to reduce their sedentary time, improve their daily physical activity, exercise capacity, decrease frailty and improve health-related quality of life.\n\nParticipants will, on a background of standard guideline-directed medical therapy patients, be randomised to tailored activity advice (control) or the Heart-Exergame (Heart-eXg) intervention for a period of 3 months. Patients randomised to the Heart-eXg group will receive an exergame with feedback and tailoring to adapt the exergaming advice. Patients will also be able to play with a person in their own network.",[269],"Cardiovascular Diseases","2026-03-09",{"date":272,"type":273},"2026-03-10","ACTUAL",{"date":275,"type":273},"2022-05-16",{"date":277,"type":263},"2027-07-30",{"name":5,"class":6},12]