[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07425769":3,"trial-entities:NCT07425769":178,"trial-summary:NCT07425769":183},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":40,"secondary_outcomes":59,"sex":130,"minimum_age":131,"maximum_age":131,"healthy_volunteers":15,"eligibility_criteria":132,"std_ages":146,"locations":150,"central_contacts":170,"overall_officials":174,"references":176,"see_also_links":177},"NCT07425769","STUDY00162196","Adapting RDAD for DS","Adapting the RDAD Intervention for Individuals With Down Syndrome Phase 3- Pilot Test","RECRUITING","2026-12-31","2026-05","2026-08-03","2026-03-31","University of Kansas Medical Center","OTHER",false,"The goal of this clinical trial is to observe feasibility and initial efficacy of a remotely delivered exercise and dementia caregiving intervention in older adults with Down syndrome and their caregivers.","In Adapting RDAD for DS Phase 3 (CareFit-DS\u002FAD), we will conduct a 12-week, single arm pilot trial intervention in 20 adults with DS\u002Fcaregiver dyads. This intervention includes remote-delivered functional exercise classes for adults with DS and their caregivers, and remote delivered dementia caregiving training sessions for the caregivers. Participants with DS will complete 12 weeks of group exercise sessions (three \\~30-minute sessions per week, caregiver optional) over video call, and caregivers will also receive a weekly \\~40-minute group video call session of a dementia caregiver training\u002Fsupport group.\n\nFor participants within 50 miles of the study site, staff will travel to participant homes at baseline and following 12 weeks to perform assessments of physical function and to set up the Actigraph accelerometers. Saliva collection kits for caregivers will be mailed ahead of time and picked up at the home visit. Additionally, at baseline staff will deliver equipment for intervention delivery\n\nFor participants greater than 50 miles of the study site, staff will mail study equipment, including the Actigraph accelerometer, and schedule a video orientation meeting to assist with equipment setup. Physical function and caregiver saliva collection will not be collected for these participants.\n\nTwelve unique pre-recorded exercise class sessions (endurance, strength, balance, and flexibility) will be performed 3 times each throughout the study (36 sessions total). The exercise session content and frequency are designed to improve functional fitness for daily activities and will challenge participants at a light and\u002For moderate intensity level. During the sessions, all participants will join a video call and follow along with a pre-recorded exercise video in a group format. A staff member trained in working with the population will be on the call to provide encouragement and feedback, while monitoring for participant safety. Caregivers may attend and participate in the exercise sessions, but will neither be encouraged or discouraged from doing so.\n\nCaregivers will be asked to attend weekly group behavioral management training sessions via video call immediately following one of the 3 exercise sessions. These meetings will consist of information and resources for caregiving for a person with DS who has been diagnosed with dementia. The group will be moderated by a staff member trained in working with the population and will include presented information as well as group discussion time. Topics include the Overview of Alzheimer's Disease in Down Syndrome; Behavior Management Strategies, Changing Expectations, etc.",[19,20],"Down Syndrome (DS)","Alzheimer's Disease (AD)",[],"INTERVENTIONAL","SUPPORTIVE_CARE",[25],"NA",{"count":27,"type":28},40,"ESTIMATED",[30,36],{"type":31,"name":32,"description":33,"armGroupLabels":34},"BEHAVIORAL","Remote Exercise Sessions","Participants will take part in thrice weekly exercise sessions using pre-recorded videos designed for older adults with Down syndrome. Participants will join video call and follow along with the video. A staff member familiar with the population will be on the call to provide modifications, encouragement and ensure participant safety.",[35],"Remote Exercise and Caregiver Education",{"type":31,"name":37,"description":38,"armGroupLabels":39},"Caregiver Education Sessions","Caregivers will join a once-weekly education session held via video call and led by a trained staff member. Education content will include how to support and manage challenging behaviors of older adults with Down syndrome who may be experiencing Alzheimer's disease-related symptoms.",[35],[41,45,48,52,56],{"measure":42,"description":43,"timeFrame":44},"Feasibility: Participant Recruitment","Number of participants enrolled divided by number eligible on questionnaire","Baseline",{"measure":46,"description":47,"timeFrame":44},"Feasibility: Recruitment Rate","Number of participants enrolled per month of active recruitment",{"measure":49,"description":50,"timeFrame":51},"Feasibility: Participant retention","Calculated as number of participants completing the intervention divided by the number who initiate the intervention multiplied by 100","Baseline to Week 12",{"measure":53,"description":54,"timeFrame":55},"Feasibility: Session Attendance","Calculated as the percentage of sessions attended across 12 weeks.","Across 12 week intervention",{"measure":57,"description":58,"timeFrame":55},"Feasibility: Participant Safety","Will be expressed as the total number of self-reported adverse events.",[60,64,67,70,73,76,79,82,85,88,92,94,96,98,100,102,104,106,109,112,115,118,121,124,127],{"measure":61,"description":62,"timeFrame":63},"Participant Sedentary Time","Assessed using an ActiGraph wGT3x-BT accelerometer (ActiGraph LLC, Pensacola, FL) worn on the non-dominant wrist over 7 consecutive days.","Baseline and Week 12",{"measure":65,"description":66,"timeFrame":63},"Participant Physical Activity","Light, moderate and vigorous physical activity will be assessed using an ActiGraph wGT3x-BT accelerometer (ActiGraph LLC, Pensacola, FL) worn on the non-dominant wrist over 7 consecutive days.",{"measure":68,"description":69,"timeFrame":63},"Participant Five Times Sit to Stand","Time required to stand up and return to seated position 5 times. Lower time indicates increased physical function. This will be collected from participants living within 50 miles of the study site during a home visit.",{"measure":71,"description":72,"timeFrame":63},"Participant Timed Up and Go","Time required to stand from a chair, walk 3 meters, pivot around a cone and return to a seated position. Lower times indicate increased physical function. This will be collected from participants living within 50 miles of the study site during a home visit.",{"measure":74,"description":75,"timeFrame":63},"Participant 2 Minute Step Test","Number of steps with knees reaching a height of the midpoint of the femur participants are able to complete in 2 minutes. Higher scores indicate increased physical function. This will be collected from participants living within 50 miles of the study site during a home visit.",{"measure":77,"description":78,"timeFrame":63},"Participant Frailty and Injuries: Cooperative Studies of Intervention Techniques (FICSIT-4)","The FICSIT-4 assesses static balance by positioning participants in 4 different stances: feet side-by-side; feet semi-tandem; feet tandem; and one foot. Each stance is attempted to be held for 10 seconds. Higher scores indicate improved physical function. This will be collected from participants living within 50 miles of the study site during a home visit.",{"measure":80,"description":81,"timeFrame":63},"Participant Hand Grip Strength","Grip strength for both the dominant and non-dominant hands will be assessed in triplicate and then scores averaged. Higher number indicate increased physical function. This will be collected from participants living within 50 miles of the study site during a home visit.",{"measure":83,"description":84,"timeFrame":63},"Participant Basic and Instrumental Activities of Daily Living","Will be assessed by proxy (caregiver report) using the 17-item Waisman Activities of Daily Living survey. Higher scores indicate increased independence with ADLs.",{"measure":86,"description":87,"timeFrame":63},"Participant Behavioral Symptom-Related Severity","Will be assessed by proxy report with the Neuropsychiatric Inventory Questionnaire (NPI-Q). Higher scores indicate increased frequency and severity of behavioral symptoms.",{"measure":89,"description":90,"timeFrame":91},"Participant Physical Function: PROMIS Short Form V2.0 Physical Function Surveys 8b and 8c","Participant physical function will be assessed by self-report using PROMIS Short Form Surveys 8b and 8c. These surveys consist of questions pertaining to ability to perform activities of daily living. Responses are on a 5 point scale ranging from 'Without any difficulty' scoring 5, to 'Unable to do' scoring 1. Higher scores indicate improved physical function.","Baseline and week 12",{"measure":93,"description":62,"timeFrame":63},"Caregiver Sedentary Time",{"measure":95,"description":66,"timeFrame":63},"Caregiver Physical Activity",{"measure":97,"description":69,"timeFrame":63},"Caregiver Five Times Sit to Stand",{"measure":99,"description":72,"timeFrame":63},"Caregiver Timed Up and Go",{"measure":101,"description":75,"timeFrame":63},"Caregiver 2 Minute Step Test",{"measure":103,"description":78,"timeFrame":63},"Caregiver Frailty and Injuries: Cooperative Studies of Intervention Techniques (FICSIT-4)",{"measure":105,"description":81,"timeFrame":63},"Caregiver Hand Grip Strength",{"measure":107,"description":108,"timeFrame":63},"Caregiver Strain","Will be assessed using the Modified Caregiver Strain Index which captures multiple domains of caregiver strain (physical, emotional, financial). Higher scores indicate greater burden and need for support or intervention.",{"measure":110,"description":111,"timeFrame":63},"Caregiver Unmet Needs","Will be assessed by the Measure of Unmet Needs survey. Higher scores indicate larger amounts of unmet caregiver needs.",{"measure":113,"description":114,"timeFrame":63},"Caregiver Self Efficacy","Will be measured using a 9-item dementia caregiver self-efficacy measure. Caregivers will rate their certainty of handling challenging behaviors and access to community services. Higher scores indicate higher self-efficacy.",{"measure":116,"description":117,"timeFrame":63},"Caregiver Social Support","Will be assessed with the Multidimensional Scale of Perceived Social Support (MSPSS). The MSPSS is a 12-item measure of perceived social support measured on a total sum scale and on 3 domains: family, friends, and significant others. Higher scores indicate increased perception of social support.",{"measure":119,"description":120,"timeFrame":63},"Caregiver Depression","Will be measured with the Center for Epidemiologic Studies Depression Scale. Higher scores indicate increased caregiver depression risk.",{"measure":122,"description":123,"timeFrame":63},"Caregiver Anxiety","Will be measured with the Generalized Anxiety Disorder 7-item scale (GAD-7). Higher scores indicate increased anxiety symptoms.",{"measure":125,"description":126,"timeFrame":63},"Caregiver Behavioral symptom-related distress","Will be assessed by a subscale of NPI-Q. higher scores indicate increase symptom-related caregiver distress.",{"measure":128,"description":129,"timeFrame":91},"Caregiver Physical Function: PROMIS Short Form V2.0 Physical Function Surveys 8b and 8c","Caregiver physical function will be assessed by self-report using PROMIS Short Form Surveys 8b and 8c. These surveys consist of questions pertaining to ability to perform activities of daily living. Responses are on a 5 point scale ranging from 'Without any difficulty' scoring 5, to 'Unable to do' scoring 1. Higher scores indicate improved physical function.","ALL",null,{"inclusion":133,"exclusion":141,"raw_text":145},[134,135,136,137,138,139,140,137],"Age \\>35 yrs. with a diagnosis of DS as self-reported or reported by caregiver. This age range was selected as cognitive decline related to AD is observed at age \\~31 in adults with DS.","Sufficient functional ability to understand directions, communicate preferences, wants, and needs through spoken language.","Living at home or in a supported living environment with a parent\u002Fcaregiver who agrees to serve as a study partner.","Self-reported ability to participate in physical activity.","Age ≥18 yrs.","Reports being a primary caregiver of an adult with DS.","English speaking.",[142,143,144,143],"Unable to participate in moderate-to-vigorous physical activity.","Self-reported, cardiovascular, metabolic or renal disease and\u002For signs or symptoms.","Unable to participate in moderate PA, i.e., brisk walking.","Inclusion Criteria - Adults with Down syndrome:\n\n* Age \\>35 yrs. with a diagnosis of DS as self-reported or reported by caregiver. This age range was selected as cognitive decline related to AD is observed at age \\~31 in adults with DS.\n* Sufficient functional ability to understand directions, communicate preferences, wants, and needs through spoken language.\n* Living at home or in a supported living environment with a parent\u002Fcaregiver who agrees to serve as a study partner.\n* Self-reported ability to participate in physical activity.\n\nExclusion Criteria - Adults with Down syndrome:\n\n* Unable to participate in moderate-to-vigorous physical activity.\n* Self-reported, cardiovascular, metabolic or renal disease and\u002For signs or symptoms.\n\nInclusion Criteria - Caregivers\n\n* Age ≥18 yrs.\n* Reports being a primary caregiver of an adult with DS.\n* English speaking.\n* Self-reported ability to participate in physical activity.\n\nExclusion Criteria - Caregivers\n\n* Unable to participate in moderate PA, i.e., brisk walking.\n* Self-reported, cardiovascular, metabolic or renal disease and\u002For signs or symptoms.",[147,148,149],"CHILD","ADULT","OLDER_ADULT",[151],{"facility":13,"status":8,"city":152,"state":153,"zip":154,"country":155,"contacts":156,"geoPoint":167},"Kansas City","Kansas","66160","United States",[157,162,165],{"name":158,"role":159,"phone":160,"email":161},"Amy Bodde, PhD","CONTACT","913-574-2447","abodde@kumc.edu",{"name":163,"role":159,"email":164},"Joseph Sherman","jsherman7@kumc.edu",{"name":158,"role":166},"PRINCIPAL_INVESTIGATOR",{"lat":168,"lon":169},39.11417,-94.62746,[171,172],{"name":158,"role":159,"phone":160,"email":161},{"name":173,"role":159,"email":164},"Joseph Sherman, MS",[175],{"name":158,"affiliation":13,"role":166},[],[],{"nct_id":4,"conditions":179,"biomarkers":182},[180,181],"Alzheimer's Disease","Down Syndrome",[],{"nct_id":4,"found":184,"summary":185,"prompt_version":195},true,{"design":186,"status":187,"heading":188,"summary":189,"follow_up":190,"word_count":191,"commitments":192,"compensation":193,"drugs_mentioned":194},"This is a 12-week pilot study with 20 adults with Down syndrome and their caregivers. It is a single-arm trial, meaning all participants receive the intervention.","completed","Remote Exercise and Caregiver Support for Down Syndrome and Alzheimer's Disease","This study is testing a 12-week program called \"Adapting RDAD for DS\" to help older adults with Down syndrome (DS) and their caregivers. The program includes remote exercise sessions for individuals with DS, using pre-recorded videos and a staff member on video calls to help. Caregivers will also join weekly video calls for education and support on managing challenging behaviors related to Alzheimer's disease (AD) symptoms. The main goal is to see if this program is practical to deliver and if it shows early signs of being helpful. We are looking for adults with Down syndrome over 35 years old who can understand and communicate. This study is currently recruiting 40 participants.","Participants will be assessed at baseline and after 12 weeks, which is the duration of the intervention.",112,"You would participate in three 30-minute exercise sessions per week via video call for 12 weeks. Caregivers would also attend one 40-minute weekly education session via video call. Staff will visit your home at the beginning and end of the study for assessments and equipment setup.","Not stated in the trial record.",[32],"v2"]