VR-based Physical Activity and Reminiscence Therapy

NCT ID: NCT06934720

Last Updated: 2025-05-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-19
• Study Completion Date: 2027-04-15

Brief Summary

The goal of this clinical trial is to learn if active Physical activity + virtual reality cognitive therapy (aPAVRCT) works to slow the progression of AD cognitive decline in older adults. It will also learn about the physical effects and mental effects of the aPAVRCT. The main questions it aims to answer are:

Does aPAVRCT slow the progression of AD cognitive decline? (e.g., HK-MoCA, ADAS-Cog) Does aPAVRCT improve physical function? (e.g., ADL) Does aPAVRCT improve mental health? (e.g., GDS-15, PANAS) Does aPAVRCT improve life satisfaction? Does aPAVRCT improve other cognitive or physical capacities? What issues and benefits do participants and stakeholders (e.g., families, caregivers, managers) have when taking aPAVRCT? (e.g., NPI-Q) Researchers will compare the intervention group (aPAVRCT) to a control group (rehabilitation bike) to see if aPAVRCT works to slow the progression of AD in cognitive decline.

Participants will:

Take aPAVRCT (interventional group) or usual physical acitvity (control group) at least twice a week, 15 minutes for each session, for 12-16 weeks Physiotherapies (assistants) and care professionals will do the intervention, research group will operate, observe, and assist the experiment.

All the experiment processes will be recorded. Visit the sites everyday for checkups and tests Keep a diary of their symptoms, the number of times, and any essential information

Sites: around 3-5 nursing homes, under one institution. Inclusion criteria: older adults in the setting who have the ability to pedal a rehabilitation bike.

Detailed Description

The aim of study is to investigate the effect of active Physical activity + virtual reality cognitive therapy (aPAVRCT) on cognitive function in older adults with Alzheimer's Dementia and related dementias. The investigator hypothesizes the "Physical activity + virtual environment brain stimulations' would slow the process of AD cognitive decline. The life satisfaction score in the intervention group would be higher than that of the control group.

The investigator will conduct measurements on three aspects: The Chinese version of the MoCA, physical functions, and emotional changes. Data will be collected at baseline, 4-week, 8-week, 12-week after interventions for the two groups, and a follow-up measurement. In addition, the investigator will use some qualitative methods, such as focus group, interview, observation, during and after the first 3-month intervention to identify some issues during the intervention and to probe caregivers. The investigator will use both the Ttest between the two groups (to compare cognitive decline progressions, and life satisfaction) and mixed methods to illustrate life satisfaction, especially among caregivers.

Conditions

Dementia; Neurodegenerative Disease; Mild Cognitive Impairment (MCI); Virtual Reality; Physical Activity; Alzheimer's Disease (AD); Cognitive Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental

Group Type: EXPERIMENTAL

aPAVRCT

Intervention Type: BEHAVIORAL

• We offered a system integrated with an indoor bike (for physical activity) and a multisensory VR environment (for cognitive training, such as reminiscence).
• Participants will actively navigate the virtual environment by pedaling and steering the handlebar.
• Care professionals will deliver the intervention using this system.

control

usual care (PA)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

aPAVRCT

• We offered a system integrated with an indoor bike (for physical activity) and a multisensory VR environment (for cognitive training, such as reminiscence).
• Participants will actively navigate the virtual environment by pedaling and steering the handlebar.
• Care professionals will deliver the intervention using this system.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• older adults in the setting who have the ability to pedal the rehabilitation bike

Exclusion Criteria

• Individuals self-reporting or identified by stakeholders as unwilling or unsuitable to participate.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 100 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

Other Identifiers

FS110

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HREP20220139

Identifier Type: -

Identifier Source: org_study_id