Clinical trial NCT05730790: Immersive Virtual Reality for Dual-task Training in Older Adults With Mild Cognitive Impairment: A Randomized Controlled Trial
Official title: Immersive Virtual Reality for Dual-task Training in Older Adults With Mild Cognitive Impairment: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Cognitive Impairment
Lead sponsor: Tan Tock Seng Hospital
Sponsor class: OTHER
Collaborators: name: Nanyang Polytechnic
name: National Neuroscience Institute
First posted: 2023-02-16
Enrollment: 54
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Block randomization
Primary purpose: PREVENTION

Brief summary: Mild cognitive impairment (MCI) is a pre-dementia state marked by a higher risk of conversion to dementia. Presently, strategies to delay the progression of MCI to dementia, such as routine exercise and cognitive activities, are limited and only moderately efficacious. Cognitive-motor dual task training, enhanced in a virtual reality environment, is a novel intervention for individuals with MCI.

Detailed description: A randomized controlled trial will be conducted. 54 patients with MCI will be recruited from an outpatient clinic. The participants will be randomly allocated to one of the three study arms. All three groups will participate in 2 training sessions per week for 7 weeks. Each session lasts 32 to 40 minutes.

Eligibility criteria: Inclusion Criteria:

* Age 60 - 80 years of age
* Diagnosis of mild cognitive impairment (MCI)
* Able to walk independently without assistance, whether from a person or a walking aid

Exclusion Criteria:

* Diagnosed dementia (at the point of recruitment)
* Presence of end stage lung, cardiac, liver and/or renal disease
* Unstable acute medical conditions that prevent one from exercising on a treadmill
* Presence of active arthritis, with symptoms affecting function
* Cerebrovascular and/or cardiac events in the last 6 months
* Parkinson's disease
* History of hip fracture within the last 6 months
* History of epilepsy with seizures in the last 2 years
* Poor vision, not correctable by glasses
* Hearing difficulty (if unable to hear well at normal conversational volume)
* Acute backache with pain affecting ambulation
* Acute lower limb pain with pain affecting ambulation
* Cervical spondylosis with myelopathy or cervical spine issues
* Chronic vertigo
* Vestibular problems, causing issues with balance

Primary outcomes:
measure: Change in dual-task gait cost measured using Optogait
timeFrame: Baseline, post-intervention after session 14 (week 7), 6 month
measure: Change in dual-task cognitive cost measured using corrected response rate of cognitive tasks
timeFrame: Baseline, post-intervention after session 14 (week 7), 6 month
Secondary outcomes:
measure: Change in number of falls measured using a falls diary
timeFrame: Baseline, 6 month
measure: Change in balance parameters and falls risk measured using Berg Balance Scale (BBS)
timeFrame: Baseline, post-intervention after session 14 (week 7), 6 month
measure: Change in falls risk measured using Timed Up and Go test (TUG)
timeFrame: Baseline, post-intervention after session 14 (week 7), 6 month
measure: Change in falls concerns scored using the Falls Efficacy Scale International (FES-I)
timeFrame: Baseline, post-intervention after session 14 (week 7), 6 month
measure: Change in executive function measured using Chinese Frontal Assessment Battery
timeFrame: Baseline, 6 month
measure: Change in executive function scored using the Stroop color-word test - Victoria version (VST)
timeFrame: Baseline, 6 month
measure: Change in sustained and divided attention assessed using Color Trails Test 1 and 2
timeFrame: Baseline, 6 month
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
Study officials:
affiliation: Tan Tock Seng Hospital
name: Kwee Yong Joyce Yap, M.B.B.S.
role: PRINCIPAL_INVESTIGATOR
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