Clinical trial NCT06934720: VR-based Physical Activity and Reminiscence Therapy
Official title: Active Physical Activity - Virtual Reality Cognitive Therapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Dementia
Neurodegenerative Disease
Mild Cognitive Impairment (MCI)
Virtual Reality
Physical Activity
Alzheimer&#39;s Disease (AD)
Cognitive Therapy
Lead sponsor: Hong Kong University of Science and Technology
Sponsor class: OTHER
First posted: 2025-04-18
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Clinical Trial: Eligible participants will be randomly assigned to either the intervention or control group. Each participant will attend sessions at least twice weekly (15-30 minutes per session) over 12 weeks.

Given the setting in nursing homes, variability in health status and potential hospitalizations will be accounted for. An additional three weeks will be allowed for compensatory sessions, resulting in a total duration of 12-15 weeks.

Participants may stop or drop out of the study at any time.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Hong Kong - Montreal cognitive assessment scale
timeFrame: at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention)
measure: The Integrated Alzheimer's Disease Rating Scale (iADRS)
timeFrame: at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention)
measure: Mini-Mental State Examination (MMSE)
timeFrame: 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 outcomes:
measure: Time up and Go Test
timeFrame: at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention)
measure: Sit to Stand Test
timeFrame: at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention)
measure: Geriatric depression scale (GDS-15)
timeFrame: at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention)
measure: The Cornell Scale for Depression in Dementia (CSDD)
timeFrame: at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention)
measure: Neuropsychiatric Inventory-Questionnaire (NPI-Q)
timeFrame: at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention)
measure: Positive Affect and Negative Affect Scale
timeFrame: at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention)
Other outcomes:
Locations:
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