Clinical trial NCT06313931: Effects of Cognitive-motor Training on Cognition, Depression and Daily Functioning in Patients With Mild Cognitive Impairment (MCI)
Official title: Effects of Cognitive-motor Training on Cognition, Depression and Daily Functioning in Patients With Mild Cognitive Impairment (MCI): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Mild Cognitive Impairment
Immersive Virtual Reality
Instrumental Activities of Daily Living
Motor-cognitive Training
Geriatric Depression
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 26
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Spanish version of the Montreal Cognitive Assessment (MoCA-S)
timeFrame: 6 weeks
measure: Short Geriatric Depression Scale (SGDS-S)
timeFrame: 6 weeks
measure: Instrumental Activities of Daily Living Scale (IADL-S)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Teruel
country: Spain
facility: University of Zaragoza
Study officials:
affiliation: Universidad de Zaragoza
name: Guillermo Palacios, PhD
role: PRINCIPAL_INVESTIGATOR
References: