Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Advancing Cardiovascular Health Among Adolescents With Intellectual Disabilities: Co-Development of Technology Interventions to Enhance Physical Activity

30 de octubre de 2026 actualizado por: Patricia West, Michigan State University

Adolescents with intellectual disabilities (ID) face significant health issues, particularly in managing chronic conditions such as cardiovascular (CV) health risks. These issues are exacerbated by limited physical activity (PA), health literacy challenges, and a lack of evidence-based health interventions. This project aims to address these gaps by engaging adolescents with ID and their stakeholders supporting ID as co-researchers to design, adapt, and pilot-test a virtual reality (VR)-based PA intervention tailored to their needs. The long-term goal is to dismantle factors to improve health outcomes for adolescents with ID through innovative, collaborative research that enhances health literacy, increases PA, and lowers CV health risks. The objectives of this study will address three specific aims: 1) adapt and validate research instruments by collaborating with adolescents with ID and their ID stakeholders to incorporate common language in measures for assessing health outcomes; 2) evaluate and select VR-based PA programs by engaging co-researchers in identifying effective VR exergame interventions for improving health outcomes through PA; and 3) pilot-test the VR PA intervention, which incorporates peer support. We will assess feasibility, acceptability, and preliminary efficacy of our 16-week VR exergame PA intervention using co-adapted measures and biologic CV risk measures. A quasi-experimental mixed-methods approach will be used, guided by our Logic Model. Preliminary evidence highlights the potential of interactive, technology-driven PA to address CV risks while fostering peer engagement and optimal self-efficacy to manage health. The expected outcomes are: 1) validated measures through greater health literacy, and 2) a co-designed intervention to reduce CV risks that helps adolescents with ID to take an active role in their health. By addressing critical gaps in health literacy, self-efficacy, and PA, this work advances healthcare practices and supports long-term improvements in public health.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Estimado)

77

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.

Estudio Contacto

  • Nombre: Patricia M West, PhD, RN
  • Número de teléfono: 517-432-8356
  • Correo electrónico: westpatr@msu.edu

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

11 años y mayores (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria: The study will be offered to adolescents with ID who meet eligibility criteria and provide assent and parental consent. Adolescents aged 11-17 years will be eligible if: 1) diagnosed with mild to moderate ID, 2) able to communicate through spoken language or use of augmentative and alternative communication (AAC), 3) understand spoken English, 4) absence of medical contraindications to PA and playing VR games, 5) parent/guardian agrees to attend virtual meetings and adolescents, and 6) internet access.

-

Exclusion Criteria:

-

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: Prevención
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Single

Single arm study participants will be asked to utilize a VR exercise program and complete pre/post surveys

The intervention will be delivered via home setting of the study participant (adolescent with ID). Baseline Home Visit; week 1: All pre-intervention baseline measures will be obtained, accelerometer will be fitted and applied. Home Visit 2; week 2: The participant will utilize the VR technology three sessions per week (weeks 3-16) for approximately 10 minutes per exercise session following instructions on use. Visit 3; Virtual; week 4: One of the three VR sessions per week will be virtual peer group interactions, guided by study staff. Virtual peer groups will utilize the VR technology together for at least one session of the three sessions per week for approximately 10 minutes per exercise session during weeks 4-16. Educational materials include: visual supports to guide VR use along with study team's contact information throughout the intervention. Study Completion Home Visit; after week 15: Follow up data collection. Virtual Week 16; Optional: Qualitative follow-up data collection.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Physical Activity
Periodo de tiempo: Baseline and at 16 weeks

Measure of number of steps per day, minutes of moderate/vigorous physical activity per week utilizing an ActiGraph.

Baseline and at 16 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Feasibility of Intervention
Periodo de tiempo: At 4 weeks, 8 weeks, 12 weeks, and 16 weeks

4-item, validated measure to evaluate the feasibility of immersive VR intervention.

At 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Acceptability of Intervention
Periodo de tiempo: At 4 weeks, 8 weeks, 12 weeks, and 16 weeks

4-item, validated measure to evaluate the acceptability of immersive VR intervention

At 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Virtual Reality Symptoms
Periodo de tiempo: At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks

4-item, to measure the symptoms one experiences while or after being in a VR environment. Symptoms that have been associated with VR use (general discomfort, fatigue, eyestrain, difficulty focusing, headache, fullness of head, blurred vision, dizziness with eyes closed, vertigo)

At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Multidimensional Scale of Perceived Social Support (MSPSS)
Periodo de tiempo: At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks

12-item, validated measure to assess perceptions of social support adequacy from three sources: family, friends, and significant other (subscales)

At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Multidimensional Self-efficacy for Exercise (MSES)
Periodo de tiempo: At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks

9-item, measure to assess three behavioral domains (i.e., task efficacy, coping efficacy, scheduling efficacy) that relate to exercise behavior among individuals and exercise contexts. The three behavioral domains are useful in determining the dimensions that influence exercise in a particular population segment

At baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Body Mass Index (BMI)
Periodo de tiempo: At baseline, 16 weeks

Measure of estimated body fat based on a person's height and weight. Portable stadiometer and scale use to measure height and weight

At baseline, 16 weeks
Waist circumference
Periodo de tiempo: At baseline, 16 weeks

Measure of the distance around a person's waist as a health indicator to assess risk of excess body fat for developing a chronic condition. Measuring tape utilized

At baseline, 16 weeks
Calories Burned
Periodo de tiempo: At 4 weeks, 8 weeks, 12 weeks, and 16 weeks

Measure of the rate at which an individual burns calories based on the height, weight, age, and gender entered into an individual's app account.

Fitbit wearable activity monitor and mobile app utilized

At 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Heart Rate
Periodo de tiempo: At 4 weeks, 8 weeks, 12 weeks, and 16 weeks

Measure of number of individual's heart beats per minute (bpm) with various activities. Fitbit wearable activity monitor and mobile app utilized

At 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Active Zone Minutes per Day
Periodo de tiempo: At 4 weeks, 8 weeks, 12 weeks, and 16 weeks

Measure of the time an individual spends in different heart rate zones. Fitbit wearable activity monitor and mobile app utilized

At 4 weeks, 8 weeks, 12 weeks, and 16 weeks

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Patricia M West, PhD, RN, Michigan State University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

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 (Estimado)

30 de noviembre de 2026

Finalización primaria (Estimado)

31 de enero de 2029

Finalización del estudio (Estimado)

31 de enero de 2029

Fechas de registro del estudio

Enviado por primera vez

30 de octubre de 2026

Primero enviado que cumplió con los criterios de control de calidad

30 de octubre de 2026

Publicado por primera vez (Actual)

5 de noviembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de noviembre de 2026

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

30 de octubre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

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. .

Suscribir