An Integrated Intervention of Computerized Cognitive Training and Physical Exercise in Virtual Reality for People With Alzheimer's Disease (JDome)
NCT ID: NCT05402423
Last Updated: 2023-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2022-06-27
2023-06-26
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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JDome rehabilitation group
Patients will undergo cognitive training with Brainer web platform via tablet followed by aerobic exercise with the JDome System
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,
control group
Patients will undergo cognitive training with Brainer web platform via tablet followed by aerobic exercise with standard exercise bike
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
Interventions
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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,
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
65 Years
ALL
No
Sponsors
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Fondazione Cariverona, Italy
UNKNOWN
Istituto Nazionale di Ricovero e Cura per Anziani
OTHER
Responsible Party
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Principal Investigators
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Giuseppe Pelliccioni, MD
Role: PRINCIPAL_INVESTIGATOR
IRCCS INRCA, Ancona, Italy
Locations
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Cognitive Disorders and Dementia (CDCD) -INRCA Hospital
Ancona, , Italy
Countries
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References
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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.
Other Identifiers
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INRCA_003_2022
Identifier Type: -
Identifier Source: org_study_id
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