Clinical trial NCT05402423: An Integrated Intervention of Computerized Cognitive Training and Physical Exercise in Virtual Reality for People With Alzheimer's Disease (JDome)
Official title: An Integrated Intervention of Computerized Cognitive Training and Physical Exercise in Virtual Reality for People With Alzheimer's Disease: the JDome Study Protocol
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Alzheimer Disease
Keywords: Alzheimer Disease
virtual system
aerobic exercise
cognitive training
dementia
quality of life
Lead sponsor: Istituto Nazionale di Ricovero e Cura per Anziani
Sponsor class: OTHER
Collaborators: name: Fondazione Cariverona, Italy
First posted: 2022-06-02
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: change in cognitive impairment
timeFrame: baseline, 8, and 22 weeks later
measure: change in short and medium term memory
timeFrame: baseline, 8 and 22 weeks later
Secondary outcomes:
measure: change in quality of life
timeFrame: baseline and 8, 22 weeks later
measure: change in physical performance
timeFrame: baseline, 8 and 22 weeks later
measure: change in signs and symptoms of major depression
timeFrame: baseline, 8 and 22 weeks later
measure: change in neuropsychiatric disturbances
timeFrame: baseline, 8 and 22 weeks later
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: Cognitive Disorders and Dementia (CDCD) -INRCA Hospital
Study officials:
affiliation: IRCCS INRCA, Ancona, Italy
name: Giuseppe Pelliccioni, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gambella E, Margaritini A, Benadduci M, Rossi L, D'Ascoli P, Riccardi GR, Pasquini S, Civerchia P, Pelliccioni G, Bevilacqua R, Maranesi E. An integrated intervention of computerized cognitive training and physical exercise in virtual reality for people with Alzheimer's disease: The jDome study protocol. Front Neurol. 2022 Aug 12;13:964454. doi: 10.3389/fneur.2022.964454. eCollection 2022.