VR-based Physical Activity and Reminiscence Therapy

Official title

Active Physical Activity - Virtual Reality Cognitive Therapy

Overview

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.

Interventions

• 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.

Primary outcome measures

• Hong Kong - Montreal cognitive assessment scale [Time frame: 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) [Time frame: 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) [Time frame: 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 (6)

• Time up and Go Test [Time frame: 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 [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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 [Time frame: at the baseline, during intervention (4-week, 8-week, 12-week, 16-week), and post-intervention assessment (3 months, 6 months after the intervention)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06934720 · HREP20220139 · FS110

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗