DementiaPhase 1/2NCT06934720
VR-based Physical Activity and Reminiscence Therapy
A Phase 1/2 study testing aPAVRCT in people with Dementia and Neurodegenerative Disease, run by Hong Kong University of Science and Technology.
Trial summary
The goal of this clinical trial is to learn if active Physical activity + virtual reality cognitive therapy (aPAVRCT) works to slow the progression of AD cognitive decline in older adults. It will also learn about the physical effects and mental effects of the aPAVRCT. Read more about this study
- Who is it for?
- Ages 60 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia, Neurodegenerative Disease, Mild Cognitive Impairment (MCI)
- What is being tested?
- aPAVRCT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 19 May 2025to 15 Apr 2027
- Phase
- Phase 1/2
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- older adults in the setting who have the ability to pedal the rehabilitation bike
Who cannot join
- Individuals self-reporting or identified by stakeholders as unwilling or unsuitable to participate.
About this study
Official title: Active Physical Activity - Virtual Reality Cognitive Therapy
The goal of this clinical trial is to learn if active Physical activity + virtual reality cognitive therapy (aPAVRCT) works to slow the progression of AD cognitive decline in older adults. It will also learn about the physical effects and mental effects of the aPAVRCT. The main questions it aims to answer are:
Does aPAVRCT slow the progression of AD cognitive decline? (e.g., HK-MoCA, ADAS-Cog) Does aPAVRCT improve physical function? (e.g., ADL) Does aPAVRCT improve mental health? (e.g., GDS-15, PANAS) Does aPAVRCT improve life satisfaction? Does aPAVRCT improve other cognitive or physical capacities? What issues and benefits do participants and stakeholders (e.g., families, caregivers, managers) have when taking aPAVRCT? (e.g., NPI-Q) Researchers will compare the intervention group (aPAVRCT) to a control group (rehabilitation bike) to see if aPAVRCT works to slow the progression of AD in cognitive decline.
Read more
Participants will:
Take aPAVRCT (interventional group) or usual physical acitvity (control group) at least twice a week, 15 minutes for each session, for 12-16 weeks Physiotherapies (assistants) and care professionals will do the intervention, research group will operate, observe, and assist the experiment.
All the experiment processes will be recorded. Visit the sites everyday for checkups and tests Keep a diary of their symptoms, the number of times, and any essential information
Sites: around 3-5 nursing homes, under one institution. Inclusion criteria: older adults in the setting who have the ability to pedal a rehabilitation bike.
Read the detailed description
The aim of study is to investigate the effect of active Physical activity + virtual reality cognitive therapy (aPAVRCT) on cognitive function in older adults with Alzheimer's Dementia and related dementias. The investigator hypothesizes the "Physical activity + virtual environment brain stimulations' would slow the process of AD cognitive decline. The life satisfaction score in the intervention group would be higher than that of the control group.
The investigator will conduct measurements on three aspects: The Chinese version of the MoCA, physical functions, and emotional changes. Data will be collected at baseline, 4-week, 8-week, 12-week after interventions for the two groups, and a follow-up measurement. In addition, the investigator will use some qualitative methods, such as focus group, interview, observation, during and after the first 3-month intervention to identify some issues during the intervention and to probe caregivers. The investigator will use both the Ttest between the two groups (to compare cognitive decline progressions, and life satisfaction) and mixed methods to illustrate life satisfaction, especially among caregivers.
- Conditions
- Dementia, Neurodegenerative Disease, Mild Cognitive Impairment (MCI), Virtual Reality, Physical Activity, Alzheimer's Disease (AD)
- Being tested
- aPAVRCT
- Medical subject headings
- Dementia, Neurodegenerative Diseases, Cognitive Dysfunction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aPAVRCTBehavioural
- We offered a system integrated with an indoor bike (for physical activity) and a multisensory VR environment (for cognitive training, such as reminiscence).
- Participants will actively navigate the virtual environment by pedaling and steering the handlebar.
- Care professionals will deliver the intervention using this system.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Not described Receives: Behavioral: aPAVRCT |
| control | No intervention | usual care (PA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hong Kong - Montreal cognitive assessment scale
MoCA is a cognitive assessment method for dementia, particularly mild stages of cognitive impairment. (range, 0-30, with lower scores indicating greater cognitive impairment)
Measured: at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention)
The Integrated Alzheimer's Disease Rating Scale (iADRS)
iADRS (range, 0-144, with lower scores indicating greater cognitive and functional described impairment) is to assess both cognitive and physical functions for dementia, combines the 13-item cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog13 ), the Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Inventory (ADCS-iADL).
Measured: at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention)
Mini-Mental State Examination (MMSE)
For cognitive assessment, (range: 0-144, with lower scores indicating greater cognitive impairment)
Measured: at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention)
Secondary outcomes (6)
Time up and Go Test
TUG test evaluates fall risk, mobility and physical performance in the elderly
Measured: at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention)
Sit to Stand Test
sit to stand test is a test that evaluates the functional strength of the lower extremity, balance and fall risk.
Measured: at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention)
Geriatric depression scale (GDS-15)
Geriatric depression scale identifies possible depression in older adults. Range: 0-15, with higher scores indicating greater possible depression.
Measured: at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention)
The Cornell Scale for Depression in Dementia (CSDD)
CSDD is to assess changes in a person's mood, behaviours and routines which may be symptoms of depression. Range: 0-38, with higher scores indicating greater depression symptoms
Measured: at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention)
Neuropsychiatric Inventory-Questionnaire (NPI-Q)
NPI-Q is to interview informant for symptom severity and caregiver distress. Range: 0-36, higher score indicates greater neuropsychiatric disturbances or caregiver distress.
Measured: at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention)
Positive Affect and Negative Affect Scale
PANAS is used to assess positive and negative emotional status and changes. This self-report questionnaire consists of two 10-item scales to measure positive and negative. The total score is calculated by finding the sum of the 10 positive items, and then the 10 negative items. Scores range from 10 - 50 for both sets of items. For the total positive score, a higher score indicates more of a positive affect. For the total negative score, a lower score indicates less of a negative affect.
Measured: at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start19 May 2025 (estimated)
- Primary completion15 Apr 2027 (estimated)
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Clinical Trial: Eligible participants will be randomly assigned to either the intervention or control group. Each participant will attend sessions at least twice weekly (15-30 minutes per session) over 12 weeks. Given the setting in nursing homes, variability in health status and potential hospitalizations will be accounted for. An additional three weeks will be allowed for compensatory sessions, resulting in a total duration of 12-15 weeks. Participants may stop or drop out of the study at any time.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Kong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GE LIN KAN, Hong Kong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06934720
- Sponsor's protocol ID
- HREP20220139
- Other IDs
- FS110
- Status last verified
- May 2025
- First submitted
- 5 Apr 2025
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Physical Activity - Virtual Reality Cognitive Therapy
- ClinicalTrials.gov ID
- NCT06934720
- Acronym / sponsor ID
- HREP20220139
- Conditions
- Dementia, Neurodegenerative Disease, Mild Cognitive Impairment (MCI), Virtual Reality, Physical Activity, Alzheimer's Disease (AD)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hong Kong University of Science and TechnologyUniversity, hospital or other
- Study start
- 19 May 2025 (estimated)
- Primary completion
- 15 Apr 2027 (estimated)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 18 Apr 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.
The goal of this clinical trial is to learn if active Physical activity + virtual reality cognitive therapy (aPAVRCT) works to slow the progression of AD cognitive decline in older adults. It will also learn about the physical effects and mental effects of the aPAVRCT. The main questions it aims to answer are:
Does aPAVRCT slow the progression of AD cognitive decline? (e.g., HK-MoCA, ADAS-Cog) Does aPAVRCT improve physical function? (e.g., ADL) Does aPAVRCT improve mental health? (e.g., GDS-15, PANAS) Does aPAVRCT improve life satisfaction? Does aPAVRCT improve other cognitive or physical capacities? What issues and benefits do participants and stakeholders (e.g., families, caregivers, managers) have when taking aPAVRCT? (e.g., NPI-Q) Researchers will compare the intervention group (aPAVRCT) to a control group (rehabilitation bike) to see if aPAVRCT works to slow the progression of AD in cognitive decline.
Participants will:
Take aPAVRCT (interventional group) or usual physical acitvity (control group) at least twice a week, 15 minutes for each session, for 12-16 weeks Physiotherapies (assistants) and care professionals will do the intervention, research group will operate, observe, and assist the experiment.
All the experiment processes will be recorded. Visit the sites everyday for checkups and tests Keep a diary of their symptoms, the number of times, and any essential information
Sites: around 3-5 nursing homes, under one institution. Inclusion criteria: older adults in the setting who have the ability to pedal a rehabilitation bike.
Detailed description
The aim of study is to investigate the effect of active Physical activity + virtual reality cognitive therapy (aPAVRCT) on cognitive function in older adults with Alzheimer's Dementia and related dementias. The investigator hypothesizes the "Physical activity + virtual environment brain stimulations' would slow the process of AD cognitive decline. The life satisfaction score in the intervention group would be higher than that of the control group.
The investigator will conduct measurements on three aspects: The Chinese version of the MoCA, physical functions, and emotional changes. Data will be collected at baseline, 4-week, 8-week, 12-week after interventions for the two groups, and a follow-up measurement. In addition, the investigator will use some qualitative methods, such as focus group, interview, observation, during and after the first 3-month intervention to identify some issues during the intervention and to probe caregivers. The investigator will use both the Ttest between the two groups (to compare cognitive decline progressions, and life satisfaction) and mixed methods to illustrate life satisfaction, especially among caregivers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial: Eligible participants will be randomly assigned to either the intervention or control group. Each participant will attend sessions at least twice weekly (15-30 minutes per session) over 12 weeks. Given the setting in nursing homes, variability in health status and potential hospitalizations will be accounted for. An additional three weeks will be allowed for compensatory sessions, resulting in a total duration of 12-15 weeks. Participants may stop or drop out of the study at any time.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: aPAVRCT |
| control | No intervention | –usual care (PA) |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- older adults in the setting who have the ability to pedal the rehabilitation bike
Key exclusion criteria (1 listed)
- Individuals self-reporting or identified by stakeholders as unwilling or unsuitable to participate.
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 |
|---|---|---|
| aPAVRCT* We offered a system integrated with an indoor bike (for physical activity) and a multisensory VR environment (for cognitive training, such as reminiscence). * Participants will actively navigate the virtual environment by pedaling and steering the handlebar. * Care professionals will deliver the intervention using this system. | Behavioural | Experimental |
Primary outcome
Hong Kong - Montreal cognitive assessment scale
Time frame: at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention)
MoCA is a cognitive assessment method for dementia, particularly mild stages of cognitive impairment. (range, 0-30, with lower scores indicating greater cognitive impairment)
The Integrated Alzheimer's Disease Rating Scale (iADRS)
Time frame: at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention)
iADRS (range, 0-144, with lower scores indicating greater cognitive and functional described impairment) is to assess both cognitive and physical functions for dementia, combines the 13-item cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog13 ), the Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Inventory (ADCS-iADL).
Mini-Mental State Examination (MMSE)
Time frame: at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention)
For cognitive assessment, (range: 0-144, with lower scores indicating greater cognitive impairment)
6 secondary outcomes
Time up and Go Test
Time frame: at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention)
Sit to Stand Test
Time frame: at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention)
Geriatric depression scale (GDS-15)
Time frame: at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention)
The Cornell Scale for Depression in Dementia (CSDD)
Time frame: at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention)
Neuropsychiatric Inventory-Questionnaire (NPI-Q)
Time frame: at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention)
Positive Affect and Negative Affect Scale
Time frame: at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the 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 22 May 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing aPAVRCT in people with Dementia and Neurodegenerative Disease, run by Hong Kong University of Science and Technology.
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 1 inclusion and 1 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 22 May 2025. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Hong Kong - Montreal cognitive assessment scale (time frame: at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention)). The study lists 3 primary outcomes in all. 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 22 May 2025.