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

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06313931
• Other study ID #: UTI-IIDI-074-2023
• Status: Completed
• Phase: N/A
• Start date: July 3, 2023
• Est. completion date: September 14, 2023

Study information

• Verified date: March 2024
• Source: Universidad de Zaragoza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 14, 2023
• Est. primary completion date: September 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Depression
• Mild Cognitive Impairment

Intervention

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:
• cognitive training via paper and pencil
20 minutes per session, twice a week for six weeks (totaling 12 sessions), using cards.
• motor stimulation
motor stimulation for 12 sessions (20 minutes per session)

Locations

Country	Name	City	State
Spain	University of Zaragoza	Teruel

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Zaragoza

Country where clinical trial is conducted

Spain, 

Outcome

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