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

NCT07183033 | Enrolling By Invitation

• 1 other identifier: 2025-248
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cognitive Frailty

Keywords

cognitive frailty; virtual reality

Outcome Measures

Primary Outcomes (1)

• fNIRS

  Neural activity during the intervention tasks will be recorded using a functional near-infrared spectroscopy (fNIRS) imaging system. A 24-channel NirLight fNIRS device (Huairui Medical Technology Co., Ltd., China) will be employed, with light sources operating at wavelengths of 760-850 nm and a sampling rate of 10 Hz. The probe configuration will primarily cover the frontal, parietal, and parts of the temporal and occipital lobes.

  Baseline, 2 Weeks, 4 Weeks

Secondary Outcomes (2)

• Cognitive function

  Baseline, 4 Weeks

• Frailty

  Baseline, 4 Weeks

Study Arms (2)

VR-Based Resistance Training Intervention

EXPERIMENTAL

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.

Behavioral: VR-Based Resistance Training Intervention

Standardized Leg-Raising Training

ACTIVE COMPARATOR

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.

Behavioral: Standardized Leg-Raising Training

Interventions

VR-Based Resistance Training Intervention BEHAVIORAL

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.

VR-Based Resistance Training Intervention

Standardized Leg-Raising Training BEHAVIORAL

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.

Standardized Leg-Raising Training

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College: lead

Study Sites (1)

School of Nursing, Chinese Academy of Medical Sciences & Peking Union Medical College

Beijing, Beijing Municipality, 100144, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 19, 2025
• Study Start: July 21, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)