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

S

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status

Withdrawn

Conditions

Alzheimer Disease

Treatments

Device: Computerized cognitive training plus aerobic exercise with standard exercise bike
Device: Computerized cognitive training plus aerobic exercise with the JDome System

Study type

Interventional

Funder types

Other

Identifiers

NCT05402423
INRCA_003_2022

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Aged 65 and over;
  • Pre-existing diagnosis of Alzheimer's, in mild phase, according to the 2011 criteria of the National Institute on Aging-Alzheimer's Association (NIA-AA);
  • Clinical Dementia Rating Scale CDR = 1;
  • Mini Mental State Examination MMSE > 19;
  • Functional Ambulation Categories FAC ≥4;
  • Tinetti scale ≥ 20;
  • Presence of a contact family caregiver
  • Reside at home

Exclusion criteria

  • Failure to meet the inclusion criteria
  • Sensory deficits not compensated by the use of prostheses
  • Psychological and behavioral disorders not compensated by drug treatment
  • Medical contraindication to moderate intensity aerobic exercise

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

JDome rehabilitation group
Experimental group
Description:
Patients will undergo cognitive training with Brainer web platform via tablet followed by aerobic exercise with the JDome System
Treatment:
Device: Computerized cognitive training plus aerobic exercise with the JDome System
control group
Active Comparator group
Description:
Patients will undergo cognitive training with Brainer web platform via tablet followed by aerobic exercise with standard exercise bike
Treatment:
Device: Computerized cognitive training plus aerobic exercise with standard exercise bike

Trial contacts and locations

0

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Central trial contact

Anna Rita Bonfigli; Elvira Maranesi

Data sourced from clinicaltrials.gov

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