VR-based Physical Activity and Reminiscence Therapy

Active Physical Activity - Virtual Reality Cognitive Therapy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Physical Activity; Dementia; Mild Cognitive Impairment (MCI); Alzheimer's Disease (AD); Virtual Reality; Cognitive Therapy; Neurodegenerative Disease
• Intervention / Treatment: Behavioral: aPAVRCT

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental	Behavioral: 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.
No Intervention: control; usual care (PA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hong Kong - Montreal cognitive assessment scale	MoCA is a cognitive assessment method for dementia, particularly mild stages of cognitive impairment. (range, 0-30, with lower scores indicating greater cognitive impairment)	at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention)
The Integrated Alzheimer's Disease Rating Scale (iADRS)	iADRS (range, 0-144, with lower scores indicating greater cognitive and functional described impairment) is to assess both cognitive and physical functions for dementia, combines the 13-item cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog13 ), the Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Inventory (ADCS-iADL).	at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention)
Mini-Mental State Examination (MMSE)	For cognitive assessment, (range: 0-144, with lower scores indicating greater cognitive impairment)	at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time up and Go Test	TUG test evaluates fall risk, mobility and physical performance in the elderly	at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention)
Sit to Stand Test	sit to stand test is a test that evaluates the functional strength of the lower extremity, balance and fall risk.	at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention)
Geriatric depression scale (GDS-15)	Geriatric depression scale identifies possible depression in older adults. Range: 0-15, with higher scores indicating greater possible depression.	at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention)
The Cornell Scale for Depression in Dementia (CSDD)	CSDD is to assess changes in a person's mood, behaviours and routines which may be symptoms of depression. Range: 0-38, with higher scores indicating greater depression symptoms	at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention)
Neuropsychiatric Inventory-Questionnaire (NPI-Q)	NPI-Q is to interview informant for symptom severity and caregiver distress. Range: 0-36, higher score indicates greater neuropsychiatric disturbances or caregiver distress.	at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention)
Positive Affect and Negative Affect Scale	PANAS is used to assess positive and negative emotional status and changes. This self-report questionnaire consists of two 10-item scales to measure positive and negative. The total score is calculated by finding the sum of the 10 positive items, and then the 10 negative items. Scores range from 10 - 50 for both sets of items. For the total positive score, a higher score indicates more of a positive affect. For the total negative score, a lower score indicates less of a negative affect.	at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention)

Collaborators and Investigators

• Sponsor: Hong Kong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Estimated): May 19, 2025
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): April 15, 2027

Study Registration Dates

• First Submitted: April 5, 2025
• First Submitted That Met QC Criteria: April 11, 2025
• First Posted (Actual): April 18, 2025

Study Record Updates

• Last Update Posted (Actual): May 22, 2025
• Last Update Submitted That Met QC Criteria: May 18, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Neurodegenerative Diseases
• Other Study ID Numbers: HREP20220139; FS110 (Other Grant/Funding Number: Hong Kong University of Science and Technology)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No