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

NCT06982170 | Completed DMC

• 2 other identifiers: MiM20220101FS110
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (3)

• physical ability

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

• psychology and behavior, caregiver distress

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

• depression

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

Study Arms (1)

Interventional group

EXPERIMENTAL

participants who were recruited in this study, were

Device: A physical activity and reminiscence therapy

Interventions

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.

Interventional group

Eligibility Criteria

• Age: 60 Years - 110 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hong Kong University of Science and Technology: lead

Study Sites (1)

Hong Kong University of Science and Technology

Hong Kong, Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Dementia; Motor Activity

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 21, 2025
• Study Start: October 1, 2023
• Primary Completion: October 30, 2024
• Study Completion: April 15, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Locations

HK (1)