Assessing Causality of the Association Between Exercise and Neurocognitive Gains

Study Overview
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Brief Summary
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Brief Summary: The aim of this project is to examine: The effects of a community based square stepping exercise programme on cognitive and physical functions in older adults. The effects of a community based square stepping exercise programme on neuroplasticity in older adults. The effects of a community based square stepping exercise programme on structural and functional brain changes in older adults. The relationship between exercise-induced changes in neuroplasticity, structural and functional brain activations, and cognitive and physical gains in older adults.

Detailed Description
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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].

Official Title
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Assessing Causality of the Association Between Exercise and Neurocognitive Gains

Conditions
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Aging Well

Intervention / Treatment
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* Other: exercise


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention group: 3-month community based exercise program (square stepping exercise)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Square stepping exercise | Other: exercise<br>* Square stepping exercise<br>|
| No Intervention: Control<br>Passive control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Go-No-Go task change | Error rate: Number of Go responses on No-Go trials. | Baseline (week 0), mid-intervention (week 7 after session 12), post-intervention (week 13 after session 24) | 
| Stroop task colour words and colour blocks | Average response time (reaction time) for the correct colour word incongruent trials. | Baseline (week 0), mid-intervention (week 7 after session 12), post-intervention (week 13 after session 24) | 
| N-Back task change | Number of correct responses (hits) | Baseline (week 0), mid-intervention (week 7 after session 12), post-intervention (week 13 after session 24) | 
| Trail Making Test ((TMT) change | B:A: Divide the time taken for TMT B by TMT A | Baseline (week 0), mid-intervention (week 7 after session 12), post-intervention (week 13 after session 24) | 
| Digit Span task change | Maximum accurate span length for Digit Span Forward Maximum accurate span length for Digit Span Reverse | Baseline (week 0), mid-intervention (week 7 after session 12), post-intervention (week 13 after session 24) | 
| Modified Card Sorting task change | Total number of perseverative errors | Baseline (week 0), mid-intervention (week 7 after session 12), post-intervention (week 13 after session 24) | 
| Static balance (single leg) change | Duration required to perform single leg stance on left and right legs | Baseline (week 0), post-intervention (week 13 after session 24) | 
| Temporal gait parameters change | 11-meter gait test to examine gait speed | Baseline (week 0), post-intervention (week 13 after session 24) | 
| Motor learning change | Probabilistic Serial Reaction Time Task: learning index, computed using reaction time | Baseline (week 0), post-intervention (week 13 after session 24) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cortical thickness | T1 and T2 weighted images | Baseline (week 0), post-intervention (week 13 after session 24) | 
| Change in grey matter volume | T1 and T2 weighted images | Baseline (week 0), post-intervention (week 13 after session 24) | 
| Change in structural topography | T1 and T2 weighted images | Baseline (week 0), post-intervention (week 13 after session 24) | 
| Change in white matter integrity | Diffusion Tensor Imaging | Baseline (week 0), post-intervention (week 13 after session 24) | 
| Change in white matter connectivity | Diffusion Tensor Imaging | Baseline (week 0), post-intervention (week 13 after session 24) | 
| Change in functional connectivity | Resting state functional magnetic resonance imaging | Baseline (week 0), post-intervention (week 13 after session 24) | 
| Brain plasticity changes | Changes in transcranial magnetic stimulation (TMS) induced motor evoked potential amplitudes in response to theta-burst stimulation protocol | Baseline (week 0), post-intervention (week 13 after session 24) | 
| Brain plasticity changes | Changes in transcranial magnetic stimulation (TMS)-evoked potentials recorded from electroencephalography (EEG) | Baseline (week 0), post-intervention (week 13 after session 24) | 
| Brain plasticity changes | Changes in power spectral density and coherence recorded from electroencephalography (EEG) | Baseline (week 0), post-intervention (week 13 after session 24) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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healthy aging, older adults, cognition, exercise, neuroplasticity