Clinical trial NCT05511259: Assessing Causality of the Association Between Exercise and Neurocognitive Gains
Official title: Assessing Causality of the Association Between Exercise and Neurocognitive Gains
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging Well
Keywords: healthy aging
older adults
cognition
exercise
neuroplasticity
Lead sponsor: Nanyang Technological University
Sponsor class: OTHER
First posted: 2022-08-22
Enrollment: 93
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention group: 3-month community based exercise program (square stepping exercise)
Primary purpose: BASIC_SCIENCE

Brief summary: Brief Summary: The aim of this project is to examine:

1. The effects of a community based square stepping exercise programme on cognitive and physical functions in older adults.
2. The effects of a community based square stepping exercise programme on neuroplasticity in older adults.
3. The effects of a community based square stepping exercise programme on structural and functional brain changes in older adults.
4. The relationship between exercise-induced changes in neuroplasticity, structural and functional brain activations, and cognitive and physical gains in older adults.

Detailed description: It is well known regular exercise produces both physical and cognitive benefits. Emerging evidence suggests that physical movements or exercise that have concurrent cognitive demands may have more profound effects on cognitive and brain health outcomes. One training program that incorporates these components is the square stepping exercise (SSE). First demonstrated in Japan, this community-based paradigm has already shown to reduce falls risk and presents as a convenient exercise modality for older adults, that can be conducted in a group setting or even the home. The current project aims to examine the efficacy of this SSE community programme in a Singapore context on cognitive and physical health in older adults. This study also aims to quantify the neural correlates underpinning any observed improvements in cognitive and physical function. Specifically, this project will measure indices of neuroplasticity via structural and functional magnetic resonance imaging, transcranial magnetic stimulation, and electroencephalography.

Sample size estimation: n=80 for behavioural primary outcome measures and n=40 subset of larger sample for neuroimaging and neuroplasticity secondary outcome measures \[anticipated\].

Eligibility criteria: Inclusion Criteria:

* Older adults aged 55-80
* Sedentary, defined as exercise less than 3 times per week for 30 minutes

Exclusion Criteria:

* Square stepping exercise:
* Medical conditions preventing them from movement and/or exercise
* Psychiatric conditions
* Cognitive impairment of dementia
* Upper and/or lower limb injuries in the past 6 months
* History of falls in the past 6 months
* Current smokers
* Neuroimaging (all the above in addition to the following)
* Patients who have conductive, ferromagnetic, or magnet-sensitive metals implanted in head (e.g., aneurysm clip, stent).
* Implanted medical device: e.g., cardiac implants, cochlear implant, aneurysm clips, cardiac pacemaker etc.
* Non-removable metal braces or retainer (dental fillings ok).
* Permanent tattoos on head.
* Deep brain stimulators.
* Previous brain surgery or injury.
* Patient with epilepsy or any other seizure history, or immediate family history of epilepsy.
* Clinical EEG that was abnormal or where seizure activity had not been ruled out.
* Patients with history of head injury with loss of consciousness are to be investigated about the history if/before being recruited.
* Diagnosis or possibility of neurological disorder (including stroke).
* Psychiatric condition.
* Major or unstable medical condition/surgery.
* Current or suspected pregnancy or lactation.
* Illicit drug use in the last 7 days.
* Alcohol use in the last 12 hours or more than 3 standard drinks in last 24 hours.
* Recent insomnia or severe sleep deprivation.
* Participation in another study involving brain stimulation (e.g., TMS, TDCS) in the past 7 days.

Primary outcomes:
measure: Go-No-Go task change
timeFrame: Baseline (week 0), mid-intervention (week 7 after session 12), post-intervention (week 13 after session 24)
measure: Stroop task colour words and colour blocks
timeFrame: Baseline (week 0), mid-intervention (week 7 after session 12), post-intervention (week 13 after session 24)
measure: N-Back task change
timeFrame: Baseline (week 0), mid-intervention (week 7 after session 12), post-intervention (week 13 after session 24)
measure: Trail Making Test ((TMT) change
timeFrame: Baseline (week 0), mid-intervention (week 7 after session 12), post-intervention (week 13 after session 24)
measure: Digit Span task change
timeFrame: Baseline (week 0), mid-intervention (week 7 after session 12), post-intervention (week 13 after session 24)
measure: Modified Card Sorting task change
timeFrame: Baseline (week 0), mid-intervention (week 7 after session 12), post-intervention (week 13 after session 24)
measure: Static balance (single leg) change
timeFrame: Baseline (week 0), post-intervention (week 13 after session 24)
measure: Temporal gait parameters change
timeFrame: Baseline (week 0), post-intervention (week 13 after session 24)
measure: Motor learning change
timeFrame: Baseline (week 0), post-intervention (week 13 after session 24)
Secondary outcomes:
measure: Change in cortical thickness
timeFrame: Baseline (week 0), post-intervention (week 13 after session 24)
measure: Change in grey matter volume
timeFrame: Baseline (week 0), post-intervention (week 13 after session 24)
measure: Change in structural topography
timeFrame: Baseline (week 0), post-intervention (week 13 after session 24)
measure: Change in white matter integrity
timeFrame: Baseline (week 0), post-intervention (week 13 after session 24)
measure: Change in white matter connectivity
timeFrame: Baseline (week 0), post-intervention (week 13 after session 24)
measure: Change in functional connectivity
timeFrame: Baseline (week 0), post-intervention (week 13 after session 24)
measure: Brain plasticity changes
timeFrame: Baseline (week 0), post-intervention (week 13 after session 24)
measure: Brain plasticity changes
timeFrame: Baseline (week 0), post-intervention (week 13 after session 24)
measure: Brain plasticity changes
timeFrame: Baseline (week 0), post-intervention (week 13 after session 24)
Other outcomes:
measure: Subjective vitality scale change
timeFrame: Baseline (week 0), post-intervention (week 13 after session 24)
measure: Heart rate variability change
timeFrame: Baseline (week 0), post-intervention (week 13 after session 24)
measure: Falls risk change
timeFrame: Baseline (week 0), post-intervention (week 13 after session 24)
measure: Social engagement and cohesion
timeFrame: Baseline (week 0), post-intervention (week 13 after session 24)
measure: Change in mood (related to movement)
timeFrame: Baseline (week 0), post-intervention (week 13 after session 24)
Locations:
city: Singapore
country: Singapore
facility: Nanyang Technological University
Study officials:
References: