Exploratory Trial of VR Intervention on Neuroplasticity in Older Adults With Cognitive Frailty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VR-Based Resistance Training Intervention, Standardized Leg-Raising Training.
- Who it may be relevant to
- Registry conditions: Cognitive Frailty. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Exploratory Trial on the Mechanisms of VR Intervention in Promoting Neuroplasticity Among Older Adults With Cognitive Frailty
Overview
To investigate the effects of VR based intervention on neuroplasticity in older adults with cognitive frailty.
Detailed 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.
Interventions
- Behavioral VR-Based Resistance Training Intervention
Participants in the intervention group will engage with a self-developed VR resistance training program entitled "Kitten Crossing the Bridge." This program is designed to guide older adults through static lower-limb resistance exercises, while integrating rhythm control, spatial judgment, and visual feedback. The intervention will be administered over 4 weeks, with two sessions per week; each session will last approximately 20 minutes (excluding equipment setup and rest periods). All training se - Behavioral Standardized Leg-Raising Training
Participants in the control group will implement a standardized leg-raising exercise protocol, which is designed to match the intensity and rhythm of the VR-based intervention. Training will be guided by pre-recorded verbal prompts and demonstration videos developed by the research team, ensuring procedural uniformity. Each session will last approximately 20 minutes (excluding equipment setup and rest periods), with two sessions per week over a 4-week duration. All sessions will be supervised by
Primary outcome measures
- fNIRS [Time frame: Baseline, 2 Weeks, 4 Weeks]
Secondary outcome measures (2)
- Cognitive function [Time frame: Baseline, 4 Weeks]
- Frailty [Time frame: Baseline, 4 Weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
China · 1 center
- School of Nursing, Chinese Academy of Medical Sciences & Peking Union Medical College — Beijing
Identifiers
NCT: NCT07183033 · 2025-248