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Adaptación de RDAD para DS (CareFit DS/AD)

6 de noviembre de 2026 actualizado por: University of Kansas Medical Center

Adaptación de la Intervención RDAD para Personas con Síndrome de Down Fase 3 - Prueba Piloto

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.

Descripción general del estudio

Estado

Activo, no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

For 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

For 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.

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

40

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • Kansas
      • Kansas City, Kansas, Estados Unidos, 66160
        • University of Kansas Medical Center

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria - Adults with Down syndrome:

  • 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/caregiver who agrees to serve as a study partner.
  • Self-reported ability to participate in physical activity.

Exclusion Criteria - Adults with Down syndrome:

  • Unable to participate in moderate-to-vigorous physical activity.
  • Self-reported, cardiovascular, metabolic or renal disease and/or signs or symptoms.

Inclusion Criteria - Caregivers

  • Age ≥18 yrs.
  • Reports being a primary caregiver of an adult with DS.
  • English speaking.
  • Self-reported ability to participate in physical activity.

Exclusion Criteria - Caregivers

  • Unable to participate in moderate PA, i.e., brisk walking.
  • Self-reported, cardiovascular, metabolic or renal disease and/or signs or symptoms.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Remote Exercise and Caregiver Education

Single Arm with active intervention for remote exercise and caregiver education sessions
Conductual: 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.

Conductual: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Feasibility: Participant Recruitment
Periodo de tiempo: Baseline

Number of participants enrolled divided by number eligible on questionnaire
Baseline
Feasibility: Recruitment Rate
Periodo de tiempo: Baseline

Number of participants enrolled per month of active recruitment
Baseline
Feasibility: Participant retention
Periodo de tiempo: Baseline to Week 12

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
Periodo de tiempo: Across 12 week intervention

Calculated as the percentage of sessions attended across 12 weeks.
Across 12 week intervention
Feasibility: Participant Safety
Periodo de tiempo: Across 12 week intervention

Will be expressed as the total number of self-reported adverse events.
Across 12 week intervention

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Participant Sedentary Time
Periodo de tiempo: Baseline and Week 12

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
Periodo de tiempo: Baseline and Week 12

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
Periodo de tiempo: Baseline and Week 12

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.
Baseline and Week 12
Participant Timed Up and Go
Periodo de tiempo: Baseline and Week 12

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.
Baseline and Week 12
Participant 2 Minute Step Test
Periodo de tiempo: Baseline and Week 12

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.
Baseline and Week 12
Participant Frailty and Injuries: Cooperative Studies of Intervention Techniques (FICSIT-4)
Periodo de tiempo: Baseline and Week 12

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.
Baseline and Week 12
Participant Hand Grip Strength
Periodo de tiempo: Baseline and Week 12

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.
Baseline and Week 12
Participant Basic and Instrumental Activities of Daily Living
Periodo de tiempo: Baseline and Week 12

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
Periodo de tiempo: Baseline and Week 12

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
Participant Physical Function: PROMIS Short Form V2.0 Physical Function Surveys 8b and 8c
Periodo de tiempo: Baseline and week 12

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
Caregiver Sedentary Time
Periodo de tiempo: Baseline and Week 12

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
Periodo de tiempo: Baseline and Week 12

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
Periodo de tiempo: Baseline and Week 12

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.
Baseline and Week 12
Caregiver Timed Up and Go
Periodo de tiempo: Baseline and Week 12

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.
Baseline and Week 12
Caregiver 2 Minute Step Test
Periodo de tiempo: Baseline and Week 12

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.
Baseline and Week 12
Caregiver Frailty and Injuries: Cooperative Studies of Intervention Techniques (FICSIT-4)
Periodo de tiempo: Baseline and Week 12

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.
Baseline and Week 12
Caregiver Hand Grip Strength
Periodo de tiempo: Baseline and Week 12

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.
Baseline and Week 12
Caregiver Strain
Periodo de tiempo: Baseline and Week 12

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
Periodo de tiempo: Baseline and Week 12

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
Periodo de tiempo: Baseline and Week 12

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
Periodo de tiempo: Baseline and Week 12

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
Periodo de tiempo: Baseline and Week 12

Will be measured with the Center for Epidemiologic Studies Depression Scale. Higher scores indicate increased caregiver depression risk.
Baseline and Week 12
Caregiver Anxiety
Periodo de tiempo: Baseline and Week 12

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
Periodo de tiempo: Baseline and Week 12

Will be assessed by a subscale of NPI-Q. higher scores indicate increase symptom-related caregiver distress.
Baseline and Week 12
Caregiver Physical Function: PROMIS Short Form V2.0 Physical Function Surveys 8b and 8c
Periodo de tiempo: Baseline and week 12

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.
Baseline and week 12

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Physiological Stress
Periodo de tiempo: Baseline and Week 12

Will be measured by collection and analysis of salivary cortisol. Higher levels of salivary cortisol are correlated with increased stress. This will be collected from participants living within 50 miles of the study site during a home visit.
Baseline and Week 12
Intervention Acceptability
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Kansas Medical Center

Colaboradores

National Center for Advancing Translational Sciences (NCATS)

Investigadores

  • Investigador principal: Amy Bodde, PhD, University of Kansas Medical Center

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

31 de marzo de 2026

Finalización primaria (Estimado)

21 de enero de 2027

Finalización del estudio (Estimado)

1 de febrero de 2027

Fechas de registro del estudio

Enviado por primera vez

11 de febrero de 2026

Primero enviado que cumplió con los criterios de control de calidad

19 de febrero de 2026

Publicado por primera vez (Actual)

23 de febrero de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

6 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • STUDY00162196
  • KL2TR002367 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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