NCT05402423

An Integrated Intervention of Computerized Cognitive Training and Physical Exercise in Virtual Reality for People With Alzheimer's Disease (JDome)

An Integrated Intervention of Computerized Cognitive Training and Physical Exercise in Virtual Reality for People With Alzheimer's Disease: the JDome Study Protocol

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Istituto Nazionale di Ricovero e Cura per Anziani · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

JDOME is a randomized controlled trial to test the effectiveness of a computerized cognitive training with the Brainer web platform and aerobic training with the JDOME system vs. a computerized cognitive training with the Brainer web platform and aerobic training with a standard exercise bike in subjects with Alzheimer's Disease at early stage. The JDome BikeAround is a tool that take people with dementia on a virtual bicycle tour along the paths of memories. It combines an exercise bike, a dome-shaped projector and Google Street View technology.

Detailed description

JDOME study is designed as a randomized controlled trial to test the effectiveness of a training that combines the JDome virtual reality system for aerobic exercise with computerized cognitive training via tablet. The Experimental Group (EG) will receive computerized cognitive training with the Brainer web platform and aerobic training with the JDOME system (a tool that combines an exercise bike, a dome-shaped projector and Google Street View technology).The Control Group (CG) will receive computerized cognitive training with the Brainer web platform and aerobic training with a standard exercise bike. Assessment will be performed at the baseline (T0), at the end of intervention (after eight weeks -T1) and 12 weeks after the end of intervention (follow-up T2). The primary aim is to assess the stabilization of the global cognition of people with mild-stage Alzheimer's disease at the Mini-Mental State Examination (MMSE) and at the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog); The secondary aim is the analyses of the modification of the quality of life, mood, behavioral disturbances, and physical function in people with mild-stage Alzheimer's disease.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DEVICE	Computerized cognitive training plus aerobic exercise with the JDome System	Sixteen treatment sessions of 60 minutes will be conducted (2 training sessions per week, for 8 weeks). Each session will involve the following activities: * 30 minutes of computerized cognitive training with the Brainer web platform, a medical device that contains 78 exercises in the five cognitive areas involved in the degeneration process of dementia * 30 minutes of aerobic training with the JDOME system,
DEVICE	Computerized cognitive training plus aerobic exercise with standard exercise bike	Sixteen treatment sessions of 60 minutes will be conducted (2 training sessions per week, for 8 weeks). Each session will involve the following activities: * 30 minutes of computerized cognitive training with the Brainer web platform, a medical device that contains 78 exercises in the five cognitive areas involved in the degeneration process of dementia * 30 minutes of aerobic training with standard exercise bike

Timeline

• Start date: 2022-06-27
• Primary completion: 2023-06-26
• Completion: 2023-06-26
• First posted: 2022-06-02
• Last updated: 2023-10-26

Locations

1 site across 1 country: Italy