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Completed

NCT Number: NCT06313931

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

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.

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Zaragoza

Teruel, 44003, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cognitive training via immersive virtual reality

Device

20 minutes per session, twice a week for six weeks (totaling 12 sessions), using the cupboard task application.

cognitive training via paper and pencil

Other

20 minutes per session, twice a week for six weeks (totaling 12 sessions), using cards.

motor stimulation

Other

motor stimulation for 12 sessions (20 minutes per session)

Primary outcomes

  1. 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.

  2. Short Geriatric Depression Scale (SGDS-S)

    Time frame: 6 weeks

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

  3. Instrumental Activities of Daily Living Scale (IADL-S)

    Time frame: 6 weeks

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

Sponsors and collaborators

Lead sponsor

Universidad de Zaragoza

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 15, 2024
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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