Cognitive FrailtyNCT07923474
Virtual Reality Multidomain Training for Older Adults With Cognitive Frailty
A study testing Virtual Reality Multidomain Training and Multidomain Health Education in people with Cognitive Frailty, run by Zheng Li.
Trial summary
This randomized controlled trial will evaluate the effects of a virtual reality (VR) multidomain intervention on cognitive function in older adults with cognitive frailty and explore its underlying mechanisms. 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?
- Virtual Reality Multidomain Training and Multidomain Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 3 Nov 2026to 30 Jun 2027
- 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
- Age >60 years.
- FFP score ≥1.
- MMSE ≥24 and either SCD-Q9 ≥5 or MoCA <26.
- ADL score ≤26.
- Ability to follow instructions, communicate discomfort, and safely participate in VR training.
- Written informed consent.
Who cannot join
- Dementia, stroke, Parkinson's disease, spinal cord injury, or epilepsy.
- Medical, psychiatric, or neurological conditions that prevent safe participation.
- Severe or recurrent vertigo, motion sickness, or intolerance to VR.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects and Mechanisms of a Virtual Reality-Based Multidomain Intervention in Older Adults With Cognitive Frailty: A Randomized Controlled Trial
This randomized controlled trial will evaluate the effects of a virtual reality (VR) multidomain intervention on cognitive function in older adults with cognitive frailty and explore its underlying mechanisms.
Participants will receive either supervised VR training twice weekly for 8 weeks or multidomain health education. The VR program combines cognitive training, physical exercise, nutrition education, and emotional support.
Cognitive function, physical function, emotional symptoms, and nutritional status will be assessed at baseline and Week 8. Functional near-infrared spectroscopy will assess brain activity to explore potential mechanisms. Intervention feasibility, acceptability, and safety will also be evaluated.
- Conditions
- Cognitive Frailty
- Being tested
- Virtual Reality Multidomain Training, Multidomain Health Education
- Keywords
- Virtual Reality, Multidomain Intervention, Cognitive Function, Functional Near-Infrared Spectroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Multidomain TrainingBehavioural
A supervised VR program combining cognitive training, physical exercise, nutrition education, and emotional support. Participants attend two sessions weekly for 8 weeks, totaling 16 sessions. Each 45-minute session includes instruction, warm-up, approximately 25 minutes of intermittent VR training, and breaks. VR training includes approximately 10 minutes of cognitive training, 10 minutes of physical exercise, and 5 minutes of nutrition education or emotional support. Nutrition and emotional support activities alternate between the two weekly sessions. VR familiarization is provided before formal training. Task difficulty and training duration are adjusted to individual abilities and tolerance.
Multidomain Health EducationBehavioural
Participants will receive multidomain health education covering cognitive health, physical activity, nutrition, and emotional well-being. The educational content addresses the same health domains as the VR intervention.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Multidomain Intervention | Experimental | Participants will receive supervised virtual reality multidomain training twice weekly for 8 weeks, for a total of 16 sessions. Each session is planned to last approximately 45 minutes, including instruction, warm-up, intermittent VR training, breaks, and task transitions. The program combines cognitive training, physical exercise, nutrition education, and emotional support. Task difficulty and training duration will be adjusted according to individual abilities and tolerance. Receives: Behavioral: Virtual Reality Multidomain Training |
| Multidomain Health Education | Active comparator | Participants will receive multidomain health education covering cognitive health, physical activity, nutrition, and emotional well-being. Receives: Behavioral: Multidomain Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment (MoCA) will be used to assess cognitive function. Total scores range from 0 to 30, with higher scores indicating better cognitive function.
Measured: Baseline and Week 8 (end of intervention)
Secondary outcomes (4)
Short Physical Performance Battery
The Short Physical Performance Battery (SPPB) will be used to assess lower-extremity physical function through standing balance, walking speed, and repeated chair stands. Total scores range from 0 to 12, with higher scores indicating better physical performance.
Measured: Baseline and Week 8 (end of intervention)
Fried Frailty Phenotype
The Fried Frailty Phenotype (FFP) will be used to assess physical frailty based on five criteria: unintentional weight loss, exhaustion, weakness, slow walking speed, and low physical activity. Total scores range from 0 to 5, with higher scores indicating greater frailty.
Measured: Baseline and Week 8 (end of intervention)
Timed Up and Go Test (TUG)
The Timed Up and Go (TUG) test will be used to assess functional mobility. Participants rise from a chair, walk 3 meters, turn, walk back, and sit down. Completion time is recorded in seconds, with shorter times indicating better functional mobility.
Measured: Baseline and Week 8 (end of intervention)
Patient Health Questionnaire-9 (PHQ-9)
The Patient Health Questionnaire-9 (PHQ-9) will be used to assess depressive symptoms over the preceding two weeks. Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.
Measured: Baseline and Week 8 (end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start3 Nov 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zheng Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zheng Li, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07923474
- Sponsor's protocol ID
- PUMCSON-2025-21
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects and Mechanisms of a Virtual Reality-Based Multidomain Intervention in Older Adults With Cognitive Frailty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07923474
- Acronym / sponsor ID
- PUMCSON-2025-21
- Conditions
- Cognitive Frailty
- Keywords
- Virtual Reality, Multidomain Intervention, Cognitive Function, Functional Near-Infrared Spectroscopy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Zheng LiUniversity, hospital or other
- Study start
- 3 Nov 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 6 Nov 2026 (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.
This randomized controlled trial will evaluate the effects of a virtual reality (VR) multidomain intervention on cognitive function in older adults with cognitive frailty and explore its underlying mechanisms.
Participants will receive either supervised VR training twice weekly for 8 weeks or multidomain health education. The VR program combines cognitive training, physical exercise, nutrition education, and emotional support.
Cognitive function, physical function, emotional symptoms, and nutritional status will be assessed at baseline and Week 8. Functional near-infrared spectroscopy will assess brain activity to explore potential mechanisms. Intervention feasibility, acceptability, and safety will also be evaluated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Multidomain Intervention | Experimental | Behavioral: Virtual Reality Multidomain TrainingParticipants will receive supervised virtual reality multidomain training twice weekly for 8 weeks, for a total of 16 sessions. Each session is planned to last approximately 45 minutes, including instruction, warm-up, intermittent VR training, breaks, and task transitions. The program combines cognitive training, physical exercise, nutrition education, and emotional support. Task difficulty and training duration will be adjusted according to individual abilities and tolerance. |
| Multidomain Health Education | Active comparator | Behavioral: Multidomain Health EducationParticipants will receive multidomain health education covering cognitive health, physical activity, nutrition, and emotional well-being. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age >60 years.
- FFP score ≥1.
- MMSE ≥24 and either SCD-Q9 ≥5 or MoCA <26.
- ADL score ≤26.
- Ability to follow instructions, communicate discomfort, and safely participate in VR training.
Key exclusion criteria (3 listed)
- Dementia, stroke, Parkinson's disease, spinal cord injury, or epilepsy.
- Medical, psychiatric, or neurological conditions that prevent safe participation.
- Severe or recurrent vertigo, motion sickness, or intolerance to VR.
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 |
|---|---|---|
| Virtual Reality Multidomain TrainingA supervised VR program combining cognitive training, physical exercise, nutrition education, and emotional support. Participants attend two sessions weekly for 8 weeks, totaling 16 sessions. Each 45-minute session includes instruction, warm-up, approximately 25 minutes of intermittent VR training, and breaks. VR training includes approximately 10 minutes of cognitive training, 10 minutes of physical exercise, and 5 minutes of nutrition education or emotional support. Nutrition and emotional support activities alternate between the two weekly sessions. VR familiarization is provided before formal training. Task difficulty and training duration are adjusted to individual abilities and tolerance. | Behavioural | Virtual Reality Multidomain Intervention |
| Multidomain Health EducationParticipants will receive multidomain health education covering cognitive health, physical activity, nutrition, and emotional well-being. The educational content addresses the same health domains as the VR intervention. | Behavioural | Multidomain Health Education |
Primary outcome
Montreal Cognitive Assessment (MoCA)
Time frame: Baseline and Week 8 (end of intervention)
The Montreal Cognitive Assessment (MoCA) will be used to assess cognitive function. Total scores range from 0 to 30, with higher scores indicating better cognitive function.
4 secondary outcomes
Short Physical Performance Battery
Time frame: Baseline and Week 8 (end of intervention)
Fried Frailty Phenotype
Time frame: Baseline and Week 8 (end of intervention)
Timed Up and Go Test (TUG)
Time frame: Baseline and Week 8 (end of intervention)
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline and Week 8 (end of intervention)
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 6 Nov 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Multidomain Training and Multidomain Health Education in people with Cognitive Frailty, run by Zheng Li.
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 3 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: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Qian Liu (+86 13175250076 ext. Master's degre, shiliuqiana@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment (MoCA) (time frame: Baseline and Week 8 (end of intervention)). 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 6 Nov 2026.