VR-based Physical Activity and Reminiscence Therapy

NCT06934720 | Not Yet Recruiting Phase 1 DMC

• 2 other identifiers: HREP20220139FS110
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Time up and Go Test

  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

  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)

  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)

  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)

  at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention)

Study Arms (2)

Experimental

EXPERIMENTAL

Behavioral: aPAVRCT

control

NO INTERVENTION

usual care (PA)

Interventions

aPAVRCT 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.

Experimental

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hong Kong University of Science and Technology: lead

MeSH Terms

Conditions

Dementia; Neurodegenerative Diseases; Cognitive Dysfunction; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 5, 2025
• First Posted: April 18, 2025
• Study Start: May 19, 2025
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): April 15, 2027
• Last Updated: May 22, 2025

Record last verified: 2025-05