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| ID | Type | Description | Link |
|---|---|---|---|
| KL2TR002367 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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/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.
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
Twelve 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.
Caregivers 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote Exercise and Caregiver Education | Experimental | Single Arm with active intervention for remote exercise and caregiver education sessions |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote Exercise Sessions | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility: Participant Recruitment | Number of participants enrolled divided by number eligible on questionnaire | Baseline |
| Feasibility: Recruitment Rate | Number of participants enrolled per month of active recruitment | Baseline |
| 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 |
| Feasibility: Session Attendance | Calculated as the percentage of sessions attended across 12 weeks. | Across 12 week intervention |
| Feasibility: Participant Safety | Will be expressed as the total number of self-reported adverse events. | Across 12 week intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Participant Physical Activity |
| Measure | Description | Time Frame |
|---|---|---|
| Physiological Stress | Will be measured by collection and analysis of salivary cortisol. Higher levels of salivary cortisol are correlated with increased stress. | Baseline and Week 12 |
| Intervention Acceptability |
Inclusion Criteria - Adults with Down syndrome:
Exclusion Criteria - Adults with Down syndrome:
Inclusion Criteria - Caregivers
Exclusion Criteria - Caregivers
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amy Bodde, PhD | Contact | 913-574-2447 | abodde@kumc.edu | |
| Joseph Sherman, MS | Contact | jsherman7@kumc.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Recruiting | Kansas City | Kansas | 66160 | United States |
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| ID | Term |
|---|---|
| D004314 | Down Syndrome |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| Caregiver Education Sessions | Behavioral | 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. |
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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.
| Baseline and Week 12 |
| Participant Five Times Sit to Stand | Time required to stand up and return to seated position 5 times. Lower time indicates increased physical function. | Baseline and Week 12 |
| 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. | Baseline and Week 12 |
| 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. | Baseline and Week 12 |
| 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. | Baseline and Week 12 |
| 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. | Baseline and Week 12 |
| 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. | Baseline and Week 12 |
| 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. | Baseline and Week 12 |
| Caregiver 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 |
| Caregiver 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. | Baseline and Week 12 |
| Caregiver Five Times Sit to Stand | Time required to stand up and return to seated position 5 times. Lower time indicates increased physical function. | Baseline and Week 12 |
| Caregiver 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. | Baseline and Week 12 |
| Caregiver 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. | Baseline and Week 12 |
| Caregiver 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. | Baseline and Week 12 |
| Caregiver 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. | Baseline and Week 12 |
| 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. | Baseline and Week 12 |
| Caregiver Unmet Needs | Will be assessed by the Measure of Unmet Needs survey. Higher scores indicate larger amounts of unmet caregiver needs. | Baseline and Week 12 |
| 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. | Baseline and Week 12 |
| 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. | Baseline and Week 12 |
| Caregiver Depression | Will be measured with the Center for Epidemiologic Studies Depression Scale. Higher scores indicate increased caregiver depression risk. | Baseline and Week 12 |
| Caregiver Anxiety | Will be measured with the Generalized Anxiety Disorder 7-item scale (GAD-7). Higher scores indicate increased anxiety symptoms. | Baseline and Week 12 |
| Caregiver Behavioral symptom-related distress | Will be assessed by a subscale of NPI-Q. higher scores indicate increase symptom-related caregiver distress. | Baseline and Week 12 |
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
| Week 12 |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |