DementiaNCT06982170
Co-design and Pilot Study in VR-based Physical Activity and Cognitive Training
A study testing A physical activity and reminiscence therapy in people with Dementia and Physical Activity, run by Hong Kong University of Science and Technology at 1 site in Hong Kong.
Trial summary
Physical activity and reminiscence therapy alone have been studied with no clear effectiveness in Alzheimer's disease, but their combined intervention remains unknown. The health sector is now advocating the use of multiple interventions in dementia care. Read more about this study
- Who is it for?
- Ages 60 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia, Physical Activity, Reminiscence Therapy
- What is being tested?
- A physical activity and reminiscence therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Oct 2023to 15 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 110 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- people who aged above 60
- people who can pedal the usual rehabilitation bike
- people who are willing to attend this study
Who cannot join
- people who cannot cycle usual rehabilitation bike (assessed by care professionals)
- people who cannot finish MoCA,
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Hong Kong University of Science and Technology
Hong Kong, Hong Kong
About this study
Physical activity and reminiscence therapy alone have been studied with no clear effectiveness in Alzheimer's disease, but their combined intervention remains unknown. The health sector is now advocating the use of multiple interventions in dementia care. Here, we aim to develop a physical activity and reminiscence therapy device and investigate its effectiveness in older adults with dementia. As there is no existing device for the oldest old, who typically have frailty and comorbidities, we need to first design and co-design a novel device and conduct pilot studies for its feasibility, perception, sustained adoption (adherence) and then preliminary efficacy (usually pilot or phase I, and often single arm).
Read the detailed description
To slow the progression of Alzheimer's disease (AD), we need essentially design and co-design the interventional device to be effective for intervention. And since the oldest group is at high risk of dementia and AD, we wanted to address the needs of this forgotten group. there is no existing device or equipment designed for their intervention. In addition, their ability to sustain physical activity is relatively short, around 5-10 minutes, far less than the duration of normal physical activity. Hence, we need to ensure that the device is well accepted and likely to be used by the target group. Then we need to test its effectiveness.
- Conditions
- Dementia, Physical Activity, Reminiscence Therapy, Co-design, Digital Health Intervention, Alzheimer's Disease
- Being tested
- A physical activity and reminiscence therapy
- Medical subject headings
- Dementia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A physical activity and reminiscence therapyDevice
There were two parts in this study, one was co-design (participants co-designed the device) and the other was a pilot intervention. The two parts were iterative. In the interventional part, participants were asked to cycling the co-design rehabilitation bike and also did reminiscence or any cognitive therapy at the same time. The intervention session lasted at least 15 minutes, twice a week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | participants who were recruited in this study, were Receives: Device: A physical activity and reminiscence therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive ability (MoCA)
MoCA is a measurement for cognitive ability. total score is 30 points, and higher score means better cognitive capacity, while lower score means higher possibie to be diagnosed as dementia.
Measured: at the baseline, post-intervention assessment (e.g., after 12-week)
Secondary outcomes (3)
physical ability
ADL-BI is a measurement for activities of daily living, and usually for people with disabilities. total score is 100. higher score means better ability for daily living.
Measured: at the baseline, post-intervention assessment (e.g., after 12-week)
psychology and behavior, caregiver distress
NPI/NPI-Q is a measurement to assess the patient psychology/psychiatrical behavior, and caregiver burden. higher score means severe behavior and higher burden.
Measured: at the baseline, post-intervention assessment (e.g., after 12-week)
depression
GDS, geriatric depression scale is to assess the dementia depressive symptoms. GDS(15) but not the GDS(30) in the diagnosis of late-life depression. The GDS-15 has a total score range of 0 to 15, where higher scores reflect more severe levels of depression.
Measured: at the baseline, post-intervention assessment (e.g., after 12-week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start1 Oct 2023
- Primary completion30 Oct 2024
- Study completion15 Apr 2025
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 N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a co-design and feasibility study for the device and a pilot interventional study to ensure the feasibility of a larger clinical trial intervention. So, the sample size would not be big as Phase I/II, and the interventional model is usually single arm, to test pre-post changes. But the screening and eligible criteria were totally same as any clinical trials.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
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
- NCT06982170
- Sponsor's protocol ID
- MiM20220101
- Other IDs
- FS110
- Status last verified
- May 2025
- First submitted
- 13 May 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-design and Pilot Study in VR-based Physical Activity and Cognitive Training
- ClinicalTrials.gov ID
- NCT06982170
- Acronym / sponsor ID
- MiM20220101
- Conditions
- Dementia, Physical Activity, Reminiscence Therapy, Co-design, Digital Health Intervention, Alzheimer's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hong Kong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 21 May 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.
Physical activity and reminiscence therapy alone have been studied with no clear effectiveness in Alzheimer's disease, but their combined intervention remains unknown. The health sector is now advocating the use of multiple interventions in dementia care. Here, we aim to develop a physical activity and reminiscence therapy device and investigate its effectiveness in older adults with dementia. As there is no existing device for the oldest old, who typically have frailty and comorbidities, we need to first design and co-design a novel device and conduct pilot studies for its feasibility, perception, sustained adoption (adherence) and then preliminary efficacy (usually pilot or phase I, and often single arm).
Detailed description
To slow the progression of Alzheimer's disease (AD), we need essentially design and co-design the interventional device to be effective for intervention. And since the oldest group is at high risk of dementia and AD, we wanted to address the needs of this forgotten group. there is no existing device or equipment designed for their intervention. In addition, their ability to sustain physical activity is relatively short, around 5-10 minutes, far less than the duration of normal physical activity. Hence, we need to ensure that the device is well accepted and likely to be used by the target group. Then we need to test its effectiveness.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a co-design and feasibility study for the device and a pilot interventional study to ensure the feasibility of a larger clinical trial intervention. So, the sample size would not be big as Phase I/II, and the interventional model is usually single arm, to test pre-post changes. But the screening and eligible criteria were totally same as any clinical trials.
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Device: A physical activity and reminiscence therapyparticipants who were recruited in this study, were |
Who may qualify
- Ages
- 60 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- people who aged above 60
- people who can pedal the usual rehabilitation bike
- people who are willing to attend this study
Key exclusion criteria (2 listed)
- people who cannot cycle usual rehabilitation bike (assessed by care professionals)
- people who cannot finish MoCA,
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 |
|---|---|---|
| A physical activity and reminiscence therapyThere were two parts in this study, one was co-design (participants co-designed the device) and the other was a pilot intervention. The two parts were iterative. In the interventional part, participants were asked to cycling the co-design rehabilitation bike and also did reminiscence or any cognitive therapy at the same time. The intervention session lasted at least 15 minutes, twice a week for 12 weeks. | Device | Interventional group |
Primary outcome
Cognitive ability (MoCA)
Time frame: at the baseline, post-intervention assessment (e.g., after 12-week)
MoCA is a measurement for cognitive ability. total score is 30 points, and higher score means better cognitive capacity, while lower score means higher possibie to be diagnosed as dementia.
3 secondary outcomes
physical ability
Time frame: at the baseline, post-intervention assessment (e.g., after 12-week)
psychology and behavior, caregiver distress
Time frame: at the baseline, post-intervention assessment (e.g., after 12-week)
depression
Time frame: at the baseline, post-intervention assessment (e.g., after 12-week)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
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 A physical activity and reminiscence therapy in people with Dementia and Physical Activity, run by Hong Kong University of Science and Technology at 1 site in Hong Kong.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 21 May 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 Hong Kong. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cognitive ability (MoCA) (time frame: at the baseline, post-intervention assessment (e.g., after 12-week)). 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 21 May 2025.