Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:26 PM
Study NCT ID:
NCT07425769
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-23
First Post:
2026-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adapting RDAD for DS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004314', 'term': 'Down Syndrome'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-19', 'studyFirstSubmitDate': '2026-02-11', 'studyFirstSubmitQcDate': '2026-02-19', 'lastUpdatePostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Physiological Stress', 'timeFrame': 'Baseline and Week 12', 'description': 'Will be measured by collection and analysis of salivary cortisol. Higher levels of salivary cortisol are correlated with increased stress.'}, {'measure': 'Intervention Acceptability', 'timeFrame': 'Week 12', 'description': 'Will be assessed from audio recorded semi-structured interviews conducted with adult with DS/caregiver dyads within 2 weeks following completion of the 12 week intervention'}], 'primaryOutcomes': [{'measure': 'Feasibility: Participant Recruitment', 'timeFrame': 'Baseline', 'description': 'Number of participants enrolled divided by number eligible on questionnaire'}, {'measure': 'Feasibility: Recruitment Rate', 'timeFrame': 'Baseline', 'description': 'Number of participants enrolled per month of active recruitment'}, {'measure': 'Feasibility: Participant retention', 'timeFrame': 'Baseline to Week 12', 'description': 'Calculated as number of participants completing the intervention divided by the number who initiate the intervention multiplied by 100'}, {'measure': 'Feasibility: Session Attendance', 'timeFrame': 'Across 12 week intervention', 'description': 'Calculated as the percentage of sessions attended across 12 weeks.'}, {'measure': 'Feasibility: Participant Safety', 'timeFrame': 'Across 12 week intervention', 'description': 'Will be expressed as the total number of self-reported adverse events.'}], 'secondaryOutcomes': [{'measure': 'Participant Sedentary Time', 'timeFrame': 'Baseline and Week 12', 'description': 'Assessed using an ActiGraph wGT3x-BT accelerometer (ActiGraph LLC, Pensacola, FL) worn on the non-dominant wrist over 7 consecutive days.'}, {'measure': 'Participant Physical Activity', 'timeFrame': 'Baseline and Week 12', 'description': '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': 'Participant Five Times Sit to Stand', 'timeFrame': 'Baseline and Week 12', 'description': 'Time required to stand up and return to seated position 5 times. Lower time indicates increased physical function.'}, {'measure': 'Participant Timed Up and Go', 'timeFrame': 'Baseline and Week 12', 'description': '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.'}, {'measure': 'Participant 2 Minute Step Test', 'timeFrame': 'Baseline and Week 12', 'description': '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.'}, {'measure': 'Participant Frailty and Injuries: Cooperative Studies of Intervention Techniques (FICSIT-4)', 'timeFrame': 'Baseline and Week 12', 'description': '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.'}, {'measure': 'Participant Hand Grip Strength', 'timeFrame': 'Baseline and Week 12', 'description': '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.'}, {'measure': 'Participant Basic and Instrumental Activities of Daily Living', 'timeFrame': 'Baseline and Week 12', 'description': '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': 'Participant Behavioral Symptom-Related Severity', 'timeFrame': 'Baseline and Week 12', 'description': 'Will be assessed by proxy report with the Neuropsychiatric Inventory Questionnaire (NPI-Q). Higher scores indicate increased frequency and severity of behavioral symptoms.'}, {'measure': 'Caregiver Sedentary Time', 'timeFrame': 'Baseline and Week 12', 'description': 'Assessed using an ActiGraph wGT3x-BT accelerometer (ActiGraph LLC, Pensacola, FL) worn on the non-dominant wrist over 7 consecutive days.'}, {'measure': 'Caregiver Physical Activity', 'timeFrame': 'Baseline and Week 12', 'description': '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': 'Caregiver Five Times Sit to Stand', 'timeFrame': 'Baseline and Week 12', 'description': 'Time required to stand up and return to seated position 5 times. Lower time indicates increased physical function.'}, {'measure': 'Caregiver Timed Up and Go', 'timeFrame': 'Baseline and Week 12', 'description': '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.'}, {'measure': 'Caregiver 2 Minute Step Test', 'timeFrame': 'Baseline and Week 12', 'description': '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.'}, {'measure': 'Caregiver Frailty and Injuries: Cooperative Studies of Intervention Techniques (FICSIT-4)', 'timeFrame': 'Baseline and Week 12', 'description': '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.'}, {'measure': 'Caregiver Hand Grip Strength', 'timeFrame': 'Baseline and Week 12', 'description': '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.'}, {'measure': 'Caregiver Strain', 'timeFrame': 'Baseline and Week 12', 'description': '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': 'Caregiver Unmet Needs', 'timeFrame': 'Baseline and Week 12', 'description': 'Will be assessed by the Measure of Unmet Needs survey. Higher scores indicate larger amounts of unmet caregiver needs.'}, {'measure': 'Caregiver Self Efficacy', 'timeFrame': 'Baseline and Week 12', 'description': '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': 'Caregiver Social Support', 'timeFrame': 'Baseline and Week 12', 'description': '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': 'Caregiver Depression', 'timeFrame': 'Baseline and Week 12', 'description': 'Will be measured with the Center for Epidemiologic Studies Depression Scale. Higher scores indicate increased caregiver depression risk.'}, {'measure': 'Caregiver Anxiety', 'timeFrame': 'Baseline and Week 12', 'description': 'Will be measured with the Generalized Anxiety Disorder 7-item scale (GAD-7). Higher scores indicate increased anxiety symptoms.'}, {'measure': 'Caregiver Behavioral symptom-related distress', 'timeFrame': 'Baseline and Week 12', 'description': 'Will be assessed by a subscale of NPI-Q. higher scores indicate increase symptom-related caregiver distress.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Down Syndrome (DS)', "Alzheimer's Disease (AD)"]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "In Adapting RDAD for DS Phase 3 (CareFit-DS/AD), we will conduct a 12-week, single arm pilot trial intervention in 20 adults with DS/caregiver 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/support group.\n\nStaff 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\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/or 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': '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/caregiver 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/or 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/or signs or symptoms.'}, 'identificationModule': {'nctId': 'NCT07425769', 'acronym': 'CareFit DS/AD', 'briefTitle': 'Adapting RDAD for DS', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Adapting the RDAD Intervention for Individuals With Down Syndrome Phase 3- Pilot Test', 'orgStudyIdInfo': {'id': 'STUDY00162196'}, 'secondaryIdInfos': [{'id': 'KL2TR002367', 'link': 'https://reporter.nih.gov/quickSearch/KL2TR002367', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Remote Exercise and Caregiver Education', 'description': 'Single Arm with active intervention for remote exercise and caregiver education sessions', 'interventionNames': ['Behavioral: Remote Exercise Sessions', 'Behavioral: Caregiver Education Sessions']}], 'interventions': [{'name': 'Remote Exercise Sessions', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Remote Exercise and Caregiver Education']}, {'name': 'Caregiver Education Sessions', 'type': 'BEHAVIORAL', 'description': "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.", 'armGroupLabels': ['Remote Exercise and Caregiver Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'contacts': [{'name': 'Amy Bodde, PhD', 'role': 'CONTACT', 'email': 'abodde@kumc.edu', 'phone': '913-574-2447'}, {'name': 'Joseph Sherman', 'role': 'CONTACT', 'email': 'jsherman7@kumc.edu'}, {'name': 'Amy Bodde, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'centralContacts': [{'name': 'Amy Bodde, PhD', 'role': 'CONTACT', 'email': 'abodde@kumc.edu', 'phone': '913-574-2447'}, {'name': 'Joseph Sherman, MS', 'role': 'CONTACT', 'email': 'jsherman7@kumc.edu'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Advancing Translational Sciences (NCATS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}