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Completed

NCT Number: NCT06982170

Co-design and Pilot Study in VR-based Physical Activity and Cognitive Training

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).

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Key information

Conditions

Dementia Alzheimer's Disease Behavior Brain Diseases Central Nervous System Diseases Co-design Digital Health Intervention Mental Disorders Motor Activity Nervous System Diseases Neurocognitive Disorders Physical Activity Reminiscence Therapy

Age range

60 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hong Kong University of Science and Technology

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

A physical activity and reminiscence therapy

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. physical ability

    Time frame: at the baseline, post-intervention assessment (e.g., after 12-week)

    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.

  2. psychology and behavior, caregiver distress

    Time frame: at the baseline, post-intervention assessment (e.g., after 12-week)

    NPI/NPI-Q is a measurement to assess the patient psychology/psychiatrical behavior, and caregiver burden. higher score means severe behavior and higher burden.

  3. depression

    Time frame: at the baseline, post-intervention assessment (e.g., after 12-week)

    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.

Sponsors and collaborators

Lead sponsor

Hong Kong University of Science and Technology

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
May 21, 2025
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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