[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575609":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":43,"responsibleParty":59,"collaborators":62,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":25,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":25,"enrollmentInfo":75,"targetDuration":25,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":87,"overallStatus":45,"whyStopped":25,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Umeå University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"High-intensity functional exercise with cognitive challenge (HIFE+Cog)","EXPERIMENTAL","High intensity functional exercise (HIFE+Cog) program with simultaneous cognitive challenge, individually tailored and performed twice weekly for 12 weeks, in supervised groups.",[13],"Other: HIFE+cog",{"label":15,"type":16,"description":17,"interventionNames":18},"High-intensity functional exercise (HIFE)","ACTIVE_COMPARATOR","High intensity functional exercise (HIFE) program, individually tailored and performed twice weekly for 12 weeks, in supervised groups.",[19],"Other: HIFE",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"HIFE+cog","Each session will consist of individually tailored exercises performed at weight- bearing positions and covering lower leg strengthening exercises, as well as static- and dynamic balance exercises. Simultaneous cognitive exercises are added to static and dynamic balance exercises. Relative exercise intensity is encouraged to be moderate to high, and progressively adjusted by for example altering load or difficulty of the exercise. Session duration is 1 hour, including warm-up.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"HIFE","Each session will consist of individually tailored exercises performed at weight- bearing positions and covering lower leg strengthening exercises, as well as static- and dynamic balance exercises. Relative exercises intensity is encouraged to be moderate to high, and progressively adjusted by for example altering load or difficulty of the exercise. Session duration is 1 hour, including warm-up.",[15],[31],{"name":32,"affiliation":5,"role":33},"Annika Toots, PhD","PRINCIPAL_INVESTIGATOR",[35,39],{"name":32,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","0046 90 7866329","annika.toots@umu.se",{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},"Magdalena Eriksson Domellöf, PhD","0046 90 7867022","magdalena.domellof@umu.se",[44],{"facility":5,"status":45,"city":46,"state":25,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"RECRUITING","Umeå","90187","Sweden","SE",{"type":51,"coordinates":52},"Point",[53,54],20.25972,63.82842,{"lat":54,"lon":53},[57],{"name":32,"role":36,"phone":58,"phoneExt":25,"email":38},"0046907866329",{"type":33,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Annika Toots","Associate professor",[63],{"name":64,"class":65},"Region Västerbotten","OTHER_GOV","100575609","feasibility-of-high-intensity-functional-exercise-with-simultaneous-cognitive-challenge-for-older-people-with-falls-risk-100575609",false,"NCT06774508","Feasibility of High-intensity Functional Exercise with Simultaneous Cognitive Challenge for Older People with Falls Risk","The Feasibility of a High-intensity Functional Exercise Program with Simultaneous Cognitive Challenge to Improve Physical and Cognitive Function in Older People with Intermediate Risk for Falls: a Randomized Controlled Pilot Trial","Inclusion Criteria:\n\n* aged 75 years or older\n* moderate risk of falling (feeling unsteady or afraid of falling, or having fallen in the past year, with a self-selected gait speed ≤0,8 m\u002Fs or TUG \\>15 s without walking aid)\n* can walk independently indoors, without a walking aid\n* can walk 500m independently outdoors, with or without a walking aid\n\nExclusion Criteria:\n\n* a high fall risk (≥2 falls in the past year, serious injury e.g. hip fracture from a fall in the past year requiring medical care, or inability to get up from the floor after a fall)\n* Mini-Mental State Examination (MMSE) score \\\u003C24 or dementia diagnosis\n* a medical condition that may affect participation in high-intensity gait, balance, and leg strength exercise, or other movement-related conditions affecting exercise or tests (e.g., pain, dizziness, visual or hearing impairment)","ALL","75 Years",{"count":76,"type":77},33,"ESTIMATED","INTERVENTIONAL",[80],"NA","This study aims to evaluate the feasibility of a high-intensity functional exercise program with simultaneous cognitive challenge (HIFE+cog) among older people at risk of falls. The evaluation design and intervention development will be assessed with the following specific aims:\n\n1. To investigate the acceptability and safety of the HIFE+cog program in older people at risk of falls, and the methods used in the study by evaluating recruitment, compliance with the intervention, severity of adverse events reported, and participant experiences.\n2. To measure key outcome variables, including completion rates, missing data, estimates, variances, and 95% confidence intervals for between-group differences.\n\nThe study is designed as a randomized controlled pilot trial. Eligible participants will be randomized to either the intervention group (HIFE+cog) or the active control group (HIFE) to partake in individually tailored exercise, supervised and progressed by a physiotherapist, two times per week for 3 months.",[83,84,85,86],"Accidental Falls","Postural Balance","Gait","Cognition",[88,89,85,86,90,91,92],"Accidental falls","Postural balance","Exercise therapy","Resistance training","Aged","2025-02-21",{"date":95,"type":96},"2025-02-25","ACTUAL",{"date":98,"type":96},"2025-02-17",{"date":100,"type":77},"2025-09-01",{"name":5,"class":6},1]