Cognitive FrailtyNCT07183033
Exploratory Trial of VR Intervention on Neuroplasticity in Older Adults With Cognitive Frailty
A study testing VR-Based Resistance Training Intervention and Standardized Leg-Raising Training in people with Cognitive Frailty, run by Peking Union Medical College at 1 site in China.
Trial summary
To investigate the effects of VR based intervention on neuroplasticity in older adults with cognitive frailty. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cognitive Frailty
- What is being tested?
- VR-Based Resistance Training Intervention and Standardized Leg-Raising Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 21 Jul 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
School of Nursing, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, Beijing Municipality, 100144
About this study
Official title: Exploratory Trial on the Mechanisms of VR Intervention in Promoting Neuroplasticity Among Older Adults With Cognitive Frailty
To investigate the effects of VR based intervention on neuroplasticity in older adults with cognitive frailty.
Read the 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
- Being tested
- VR-Based Resistance Training Intervention, Standardized Leg-Raising Training
- Keywords
- cognitive frailty, virtual reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-Based Resistance Training InterventionBehavioural
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.
Standardized Leg-Raising TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standardized Leg-Raising Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 2 Weeks, 4 Weeks
Secondary outcomes (2)
Cognitive function
The Chinese version of the Addenbrooke's Cognitive Examination Ⅲ (ACE-Ⅲ) is a validated neuropsychological instrument designed to assess objective cognitive function across five domains: attention, memory, verbal fluency, language, and visuospatial ability. The total score ranges from 0 to 100, with higher scores indicating better cognitive function.
The Beijing version of Montreal Cognitive Assessment (MoCA) is a classical screening tool for mild cognitive impairment that evaluates seven cognitive domains: visuospatial and executive function, naming, attention, language, abstraction, delayed recall, and orientation. The total score ranges from 0 to 30, with higher scores indicating better cognitive performance.
The Subjective Cognitive Decline Questionnaire (SCD-Q9) is a brief 9-item self-report questionnaire used to assess subjective cognitive symptoms in older adults. The total score ranges from 0 to 9, with higher scores reflecting more severe subjective cognitive decline.
Measured: Baseline, 4 Weeks
Frailty
Frailty will be evaluated using the Fried phenotype model, which defines physical frailty according to five components: slowness (gait speed), weakness (hand grip strength), unintentional weight loss, exhaustion, and low physical activity. Each component is scored as present or absent, and the total score ranges from 0 to 5. A score of 0 indicates non-frail, 1-2 indicates pre-frail, and 3 or more indicates frail. Higher scores reflect more severe frailty.
Measured: Baseline, 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start21 Jul 2025
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zheng Li, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07183033
- Sponsor's protocol ID
- 2025-248
- Status last verified
- Sep 2025
- First submitted
- 3 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Trial on the Mechanisms of VR Intervention in Promoting Neuroplasticity Among Older Adults With Cognitive Frailty
- ClinicalTrials.gov ID
- NCT07183033
- Acronym / sponsor ID
- 2025-248
- Conditions
- Cognitive Frailty
- Keywords
- cognitive frailty, virtual reality
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Peking Union Medical CollegeUniversity, hospital or other
- Study start
- 21 Jul 2025 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR-Based Resistance Training Intervention | Experimental | Behavioral: VR-Based Resistance Training InterventionParticipants 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. |
| Standardized Leg-Raising Training | Active comparator | Behavioral: Standardized Leg-Raising TrainingParticipants 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR-Based Resistance Training InterventionParticipants 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. | Behavioural | VR-Based Resistance Training Intervention |
| Standardized Leg-Raising TrainingParticipants 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. | Behavioural | Standardized Leg-Raising Training |
Primary outcome
fNIRS
Time frame: Baseline, 2 Weeks, 4 Weeks
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.
2 secondary outcomes
Cognitive function
Time frame: Baseline, 4 Weeks
Frailty
Time frame: Baseline, 4 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR-Based Resistance Training Intervention and Standardized Leg-Raising Training in people with Cognitive Frailty, run by Peking Union Medical College at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fNIRS (time frame: Baseline, 2 Weeks, 4 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.