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Clinical Trials/NCT06313931
NCT06313931
Completed
Not Applicable

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

Universidad de Zaragoza1 site in 1 country26 target enrollmentJuly 3, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mild Cognitive Impairment
Sponsor
Universidad de Zaragoza
Enrollment
26
Locations
1
Primary Endpoint
Short Geriatric Depression Scale (SGDS-S)
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
July 3, 2023
End Date
September 14, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Guillermo Palacios

Principal Investigator

Universidad de Zaragoza

Eligibility Criteria

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

Outcomes

Primary Outcomes

Short Geriatric Depression Scale (SGDS-S)

Time Frame: 6 weeks

Scores in the SGDS scale. Higher scores mean a worse outcome.

Instrumental Activities of Daily Living Scale (IADL-S)

Time Frame: 6 weeks

Scores in the IADL scale. Higher scores mean a better outcome.

Spanish version of the Montreal Cognitive Assessment (MoCA-S)

Time Frame: 6 weeks

Scores in the MoCA-S scale. Higher scores mean a better outcome.

Study Sites (1)

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