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

NCT ID: NCT06982170

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2025-04-15

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.

Conditions

Dementia; Physical Activity; Reminiscence Therapy; Co-design; Digital Health Intervention; Alzheimer's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Interventional group

participants who were recruited in this study, were

Group Type: EXPERIMENTAL

A physical activity and reminiscence therapy

Intervention Type: 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.

Interventions

A physical activity and reminiscence therapy

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.

Intervention Type: DEVICE

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,

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hong Kong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

GE LIN KAN

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hong Kong University of Science and Technology

Hong Kong, Hong Kong, Hong Kong

Countries

Hong Kong

Other Identifiers

FS110

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

MiM20220101

Identifier Type: -

Identifier Source: org_study_id