[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659133":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":42,"studyPopulation":38,"armGroups":43,"interventions":56,"overallOfficials":65,"centralContacts":70,"locations":76,"responsibleParty":92,"collaborators":38,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":38,"eligibilityCriteria":100,"healthyVolunteers":96,"sex":101,"minAge":102,"maxAge":38,"enrollmentInfo":103,"targetDuration":38,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":116,"whyStopped":38,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Wake Forest University Health Sciences","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":31},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Peak Oxygen Consumption","Change in peak oxygen consumption (VO2peak)","From baseline to week 8",[14,18,22,25,28],{"measure":15,"description":16,"timeFrame":17},"Exercise Dose","Exercise dose is defined was walking duration x average treadmill speed x average treadmill grade","Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8",{"measure":19,"description":20,"timeFrame":21},"400 Meter Walk Time","Participants will be instructed to walk 400 meters at their usual fast pace without running, with standardized encouragement provided throughout the test. Participants will be permitted to slow down or rest briefly if needed for safety. Total completion time recorded. Participants will be permitted to slow down or rest briefly if needed for safety.","Baseline and Week 8",{"measure":23,"description":24,"timeFrame":21},"Expanded Short Physical Performance Battery (eSPPB)","eSPPB consists of 5 repeated chair stands, standing balance (semi- and full-tandem stands and a single leg stand for 30 seconds), a 6-meter walk to assess usual gait speed, and a narrow 6-meter walk test of balance (walking at usual pace within lines of tape spaced 20 cm apart). Total score range is 0-4 with a higher score indicating better performance.",{"measure":26,"description":27,"timeFrame":21},"PROMIS Fatigue Short Form 7a Survey","PROMIS Fatigue Short Form 7a measures the severity and functional impact of fatigue on everyday functioning. Total score range is 7-35 with a higher score indicating a higher level of fatigue.",{"measure":29,"description":30,"timeFrame":21},"Pittsburgh Fatigability Scale","Activity-related fatigability will be assessed using the Pittsburgh Fatigability Scale which evaluates perceived physical fatigue in response to standardized daily activities of defined intensity and duration. Total score range is 0-50 with higher numbers representing greater perceived fatigability.",[32],{"measure":33,"description":34,"timeFrame":21},"Oxygen Consumption Rate","Oxygen consumption rate of the peripheral blood mononuclear cells (PBMC) cells measured using respirometry.",{"allocation":36,"interventionModel":37,"interventionModelDescription":38,"primaryPurpose":39,"observationalModel":38,"timePerspective":38,"maskingInfo":40},"RANDOMIZED","PARALLEL",null,"SUPPORTIVE_CARE",{"masking":41,"maskingDescription":38,"whoMasked":38},"NONE","Study 2 is an open-label, randomized, parallel-group controlled pilot trial. Participants will be randomized in a 1:1 ratio to eight weeks of supervised We Innovate Mobility (WIM)-assisted treadmill walking or conventional treadmill walking. Exercise intensity will be prescribed using a target of 70% heart rate reserve, with speed and grade adjusted to maintain walking intensity. Outcomes will be assessed before and after the intervention.",[44,50],{"label":45,"type":46,"description":47,"interventionNames":48},"We Innovate Mobility (WIM)-Assisted Treadmill Walking","EXPERIMENTAL","participants will walk on treadmill with assistance from the We Innovate Mobility (WIM) device",[49],"Device: We Innovate Mobility (WIM) Device",{"label":51,"type":52,"description":53,"interventionNames":54},"Conventional Treadmill Walking","ACTIVE_COMPARATOR","participants will walk on treadmill without assistance from the We Innovate Mobility (WIM) device",[55],"Other: Conventional Treadmill Walking",[57,62],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":38},"DEVICE","We Innovate Mobility (WIM) Device","We Innovate Mobility (WIM) is an externally worn, powered device that provides temporary mechanical assistance during voluntary walking. Participants will walk on the treadmill three times per week for eight weeks while wearing the device.",[45],{"type":6,"name":51,"description":63,"armGroupLabels":64,"otherNames":38},"Participants will walk on the treadmill three times per week for eight weeks without assistance from the We Innovate Mobility (WIM) device.",[51],[66],{"name":67,"affiliation":68,"role":69},"Bumsoo Ahn, PhD","Atrium Health Wake Forest Baptist","PRINCIPAL_INVESTIGATOR",[71],{"name":72,"role":73,"phone":74,"phoneExt":38,"email":75},"Kim Kennedy","CONTACT","336.713.8567","kimberly.kennedy@advocatehealth.org",[77],{"facility":68,"status":38,"city":78,"state":79,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"Winston-Salem","North Carolina","27157","United States","US",{"type":84,"coordinates":85},"Point",[86,87],-80.24422,36.09986,{"lat":87,"lon":86},[90],{"name":72,"role":73,"phone":91,"phoneExt":38,"email":75},"336-713-8567",{"type":93,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100659133","wearable-robotics-to-overcome-exercise-dose-limitations-in-older-adults---study-2-100659133",false,"NCT07859605","Wearable Robotics to Overcome Exercise Dose Limitations in Older Adults - Study 2","Wearable Robotics to Overcome Exercise Dose Limitations in Older Adults","Inclusion Criteria:\n\n* Community-dwelling adult aged ≥65 years\n* Able to safely wear and use the WIM device\n* Willing to complete conventional and WIM-assisted treadmill walking\n* Able to provide informed consent and comply with study procedures\n* Able to provide informed consent and comply with study procedures\n\nExclusion Criteria:\n\n* Recent hospitalization, surgery, fracture, or other medical condition that limits safe treadmill walking\n* Resting blood pressure, heart rate, or symptoms that meet protocol-defined safety exclusion criteria before exercise\n* Requires a cane, walker, or other assistive device for ambulation\n* Regular participation in structured aerobic exercise\n* Any condition judged by the study clinician to make participation unsafe or interfere with study procedures","ALL","65 Years",{"count":104,"type":105},32,"ESTIMATED","INTERVENTIONAL",[108],"NA","The purpose of this research is to learn whether a lightweight wearable robotic device called We Innovate Mobility (WIM) can improve exercise capacity and physical function for older adults.",[111],"Mobility Disability",[113,114,115],"mobility decline","older adults","We Innovate Mobility (WIM) device","NOT_YET_RECRUITING","2026-09-30",{"date":119,"type":120},"2026-10-06","ACTUAL",{"date":122,"type":105},"2027-01",{"date":124,"type":105},"2028-12",{"name":5,"class":6},1]