NCT07183033

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

Exploratory Trial on the Mechanisms of VR Intervention in Promoting Neuroplasticity Among Older Adults With Cognitive Frailty

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Peking Union Medical College · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cognitive Frailty

Interventions

Type	Name	Description
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 sessions will be supervised by qualified staff to ensure participant safety and provide necessary support.
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 trained staff, who will monitor participant adherence and ensure safety throughout the process.

Timeline

• Start date: 2025-07-21
• Primary completion: 2025-11-30
• Completion: 2025-12-31
• First posted: 2025-09-19
• Last updated: 2025-09-19

Locations

1 site across 1 country: China