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

NCT05402423 | Withdrawn

• 1 other identifier: INRCA_003_2022
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Keywords

Alzheimer Disease; virtual system; aerobic exercise; cognitive training; dementia; quality of life

Outcome Measures

Primary Outcomes (2)

• change in cognitive impairment

  Mini-Mental State Examination was designed as a clinical method for grading cognitive impairment. The score ranges from 0 to 30: scores ≥ 24 indicate normality, between 18-23 indicate mild cognitive impairment, between 11-17 moderate cognitive deficits, scores ≤ 10 severe cognitive impairments. The reported score will be corrected according to age and education.

  baseline, 8, and 22 weeks later

• change in short and medium term memory

  Alzheimer's Disease Assessment Scale (ADAS-cog) consists of 11 items that investigate: short and medium term memory, language, praxia (simple, constructive, ideational), temporal-spatial orientation. The score ranges from 0 (no cognitive impairment) to 70 (maximum cognitive impairment).

  baseline, 8 and 22 weeks later

Secondary Outcomes (4)

• change in quality of life

  baseline and 8, 22 weeks later

• change in physical performance

  baseline, 8 and 22 weeks later

• change in signs and symptoms of major depression

  baseline, 8 and 22 weeks later

• change in neuropsychiatric disturbances

  baseline, 8 and 22 weeks later

Study Arms (2)

JDome rehabilitation group

EXPERIMENTAL

Patients will undergo cognitive training with Brainer web platform via tablet followed by aerobic exercise with the JDome System

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

control group

ACTIVE COMPARATOR

Patients will undergo cognitive training with Brainer web platform via tablet followed by aerobic exercise with standard exercise bike

Device: Computerized cognitive training plus aerobic exercise with standard exercise bike

Interventions

Computerized cognitive training plus aerobic exercise with the JDome System DEVICE

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,

JDome rehabilitation group

Computerized cognitive training plus aerobic exercise with standard exercise bike DEVICE

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

control group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Nazionale di Ricovero e Cura per Anziani: lead
• Fondazione Cariverona, Italy: collaborator

Study Sites (1)

Cognitive Disorders and Dementia (CDCD) -INRCA Hospital

Ancona, 60127, Italy

Location

Related Publications (1)

• 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.

  PMID: 36034306 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Giuseppe Pelliccioni, MD

  IRCCS INRCA, Ancona, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2022
• First Posted: June 2, 2022
• Study Start: June 27, 2022
• Primary Completion: June 26, 2023
• Study Completion: June 26, 2023
• Last Updated: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)