Exploratory Trial of VR Intervention on Neuroplasticity in Older Adults With Cognitive Frailty

Peking Union Medical College

Status: Invitation-only

Conditions: Cognitive Frailty

Treatments: Behavioral: Standardized Leg-Raising Training; Behavioral: VR-Based Resistance Training Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07183033

2025-248

Details and patient eligibility

About

To investigate the effects of VR based intervention on neuroplasticity in older adults with cognitive frailty.

Full description

This study is designed as a prospective, parallel-group, single-blind randomized controlled trial to be conducted at a senior care institution in Beijing from August to September 2025. Older adults with cognitive frailty will be randomly allocated using a computer-generated random sequence concealed in opaque sealed envelopes to either a VR-based intervention group or a control group. Allocation concealment will be maintained throughout the trial, and research staff responsible for data collection, assessment, and analysis will remain blinded to group assignments.

The intervention will comprise task-oriented VR activities specifically designed to stimulate cognitive and sensorimotor processes. Functional near-infrared spectroscopy (fNIRS) will be utilized to evaluate pre- and post-intervention neural activity, with a focus on cortical activation patterns, changes in network efficiency, and modulation of functional pathways.

This study aims to generate exploratory evidence regarding the mechanisms underlying VR-induced neuroplasticity in this population, thereby establishing a foundation for optimizing intervention parameters and targeting specific brain regions in subsequent large-scale trials.

Enrollment: 15 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Frailty Phenotype (FP) score between 1 and 5
• Subjective Cognitive Decline Questionnaire (SCD-Q9) score ≥ 5
• Montreal Cognitive Assessment (MoCA) score between 15 and 25
• Activities of Daily Living (ADL) score ≤ 26
• Age ≥ 60 years
• Submit written informed consent prior to participating in the study

Exclusion criteria

• Clinical diagnosis of Alzheimer's disease, other dementias, or neuropsychiatric disorders (e.g., cerebrovascular disease, Parkinson's disease, history of traumatic brain injury, brain tumors, epilepsy)
• Current use of medications or addictive substances that may impair cognition
• Presence of musculoskeletal disorders (e.g., osteoarthritis, fractures), cardiovascular disease, or liver/kidney dysfunction that prevent safe participation in exercise
• Severe sensory or speech impairments that hinder communication
• Severe motion sickness or vestibular disorders

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

VR-Based Resistance Training Intervention

Experimental group

Description:

Participants in the intervention group will receive training using a self-developed VR-based resistance training system named "Kitten Crossing the Bridge." This system primarily emphasizes static lower-limb resistance control and integrates mechanisms of task rhythm regulation, spatial judgment, and visual feedback. Preliminary usability testing has demonstrated good immersion, safety, and acceptability among older adults.The intervention will last for 4 weeks, with two sessions per week; each session will last approximately 20 minutes (excluding device setup and rest intervals). All sessions will be supervised by trained staff to ensure safety and provide necessary assistance.

Treatment:

Behavioral: VR-Based Resistance Training Intervention

Standardized Leg-Raising Training

Active Comparator group

Description:

Participants in the control group will perform standardized leg-raising exercises. The training rhythm will be guided by pre-recorded verbal prompts and demonstration videos developed by the research team, ensuring that the exercise intensity and pace are aligned with those of the intervention group.

Treatment:

Behavioral: Standardized Leg-Raising Training