Effects of Cognitive-motor Training on Cognition, Depression and Daily Functioning in Patients With Mild Cognitive Impairment (MCI)

Effects of Cognitive-motor Training on Cognition, Depression and Daily Functioning in Patients With Mild Cognitive Impairment (MCI): A Randomized Controlled Trial

This randomized controlled trial evaluated the effectiveness of an immersive virtual reality (IVR) application (focused on a daily activity) to train cognitive functions and its impact on depression and the ability to perform activities of daily living (ADL) in patients with mild cognitive impairment (MCI). With a dose of two sessions per week during six weeks, the study showed significant improvements in cognitive functions and reduction in depression, with notable effects in the experimental group. This underscores the potential of IVR as a valuable tool in the management of MCI.

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Device: cognitive training via immersive virtual reality; Other: motor stimulation; Other: cognitive training via paper and pencil

Detailed Description

Background:

The increase in cases of MCI underlines the urgency of finding effective methods to slow its progression. Given the limited effectiveness of current pharmacological options to prevent or treat the early stages of this deterioration, non-pharmacological alternatives are especially relevant.

Aim: The study aimed to evaluate the effectiveness of an immersive virtual reality (IVR) application, focused on an activity of daily living (ADL), to train cognitive functions and its impact on depression and the ability to perform ADL in patients with MCI. IVR is presented as an innovative tool with the potential to offer a promising non-pharmacological approach.

Methods:The researchers implemented a 40-minute-long intervention, twice a week for six weeks (totaling 12 sessions), using the cupboard task (based on IVR). The study included the participation of individuals with MCI, randomly distributed into control (n=12) and experimental (n=14) groups. The majority in the control group were women (75%), with a mean age of 77.67 years, and in the experimental group, women represented 57.14%, with a mean age of 74.86 years. Cognitive functions, depression, and the ability to perform ADLs were assessed. The scales used were: the Spanish version of the Montreal Cognitive Assessment (MoCA-S), the Short Geriatric Depression Scale (SGDS-S) and the Instrumental Activities of Daily Living Scale. (IADL-S), respectively.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Teruel, Spain, 44003
    • University of Zaragoza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 65 or older
• Community-dwelling, not in nursing homes
• Physically functional
• Understanding and voluntary consent
• Mild Cognitive Impairment (MCI)
• MoCA score of 19-25

Exclusion Criteria:

• Clinical dementia diagnosis
• MoCA ≤ 18 indicating probable dementia
• Neurological disorders including stroke or TBI in the last year
• History of mental/psychiatric disorders
• Substance abuse
• Difficulty using VR headset and controllers
• Medical conditions affecting trial participation
• Visual/hearing impairments
• Communication difficulties

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group	Other: motor stimulation; motor stimulation for 12 sessions (20 minutes per session); Other: cognitive training via paper and pencil; 20 minutes per session, twice a week for six weeks (totaling 12 sessions), using cards.
Experimental: Experimental group	Device: cognitive training via immersive virtual reality; 20 minutes per session, twice a week for six weeks (totaling 12 sessions), using the cupboard task application.; Other: motor stimulation; motor stimulation for 12 sessions (20 minutes per session)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spanish version of the Montreal Cognitive Assessment (MoCA-S)	Scores in the MoCA-S scale. Higher scores mean a better outcome.	6 weeks
Short Geriatric Depression Scale (SGDS-S)	Scores in the SGDS scale. Higher scores mean a worse outcome.	6 weeks
Instrumental Activities of Daily Living Scale (IADL-S)	Scores in the IADL scale. Higher scores mean a better outcome.	6 weeks

Collaborators and Investigators

• Sponsor: Universidad de Zaragoza
• Investigators: Principal Investigator: Guillermo Palacios, PhD, Universidad de Zaragoza

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2023
• Primary Completion (Actual): September 14, 2023
• Study Completion (Actual): September 14, 2023

Study Registration Dates

• First Submitted: March 1, 2024
• First Submitted That Met QC Criteria: March 8, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Mild Cognitive Impairment; Instrumental Activities of Daily Living; Geriatric Depression; Immersive Virtual Reality; Motor-cognitive Training
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Depression; Cognitive Dysfunction
• Other Study ID Numbers: UTI-IIDI-074-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No