Clinical trial NCT06982170: Co-design and Pilot Study in VR-based Physical Activity and Cognitive Training
Official title: Co-design and Pilot Study in VR-based Physical Activity and Cognitive Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Physical Activity
Reminiscence Therapy
Co-design
Digital Health Intervention
Alzheimer&#39;s Disease
Lead sponsor: Hong Kong University of Science and Technology
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 50
Sex: ALL
Minimum age (years): 60
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: DEVICE_FEASIBILITY

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* people who aged above 60
* people who can pedal the usual rehabilitation bike
* people who are willing to attend this study

Exclusion Criteria:

* people who cannot cycle usual rehabilitation bike (assessed by care professionals)
* people who cannot finish MoCA,

Primary outcomes:
measure: Cognitive ability (MoCA)
timeFrame: at the baseline, post-intervention assessment (e.g., after 12-week)
Secondary outcomes:
measure: physical ability
timeFrame: at the baseline, post-intervention assessment (e.g., after 12-week)
measure: psychology and behavior, caregiver distress
timeFrame: at the baseline, post-intervention assessment (e.g., after 12-week)
measure: depression
timeFrame: at the baseline, post-intervention assessment (e.g., after 12-week)
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Hong Kong University of Science and Technology
Study officials:
References: