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Assessing Causality of the Association Between Exercise and Neurocognitive Gains

Assessing Causality of the Association Between Exercise and Neurocognitive Gains

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05511259
Enrollment
93
Registered
2022-08-22
Start date
2022-05-10
Completion date
2023-04-04
Last updated
2025-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging Well

Keywords

healthy aging, older adults, cognition, exercise, neuroplasticity

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 \[anticipated\].

Interventions

OTHERexercise

Square stepping exercise

Sponsors

Nanyang Technological University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Intervention model description

Intervention group: 3-month community based exercise program (square stepping exercise)

Eligibility

Sex/Gender
ALL
Age
55 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Change in functional connectivityBaseline (week 0), post-intervention (week 13 after session 24)Resting state functional magnetic resonance imaging
Change in cortical thicknessBaseline (week 0), post-intervention (week 13 after session 24)T1 and T2 weighted images
Change in grey matter volumeBaseline (week 0), post-intervention (week 13 after session 24)T1 and T2 weighted images
Change in structural topographyBaseline (week 0), post-intervention (week 13 after session 24)T1 and T2 weighted images
Change in white matter integrityBaseline (week 0), post-intervention (week 13 after session 24)Diffusion Tensor Imaging
Change in white matter connectivityBaseline (week 0), post-intervention (week 13 after session 24)Diffusion Tensor Imaging
Brain plasticity changesBaseline (week 0), post-intervention (week 13 after session 24)Changes in transcranial magnetic stimulation (TMS) induced motor evoked potential amplitudes in response to theta-burst stimulation protocol

Other

MeasureTime frameDescription
Subjective vitality scale changeBaseline (week 0), post-intervention (week 13 after session 24)5-item vitality score (7-point scale, higher score greater wellbeing outcome)
Change in mood (related to movement)Baseline (week 0), post-intervention (week 13 after session 24)Anxiety and depression subscale of Movement Specific Reinvestment Scale: 10-item, 6-point for anxiety and depression around movement. Higher scores = more symptoms of anxiety and depression.
Social engagement and cohesionBaseline (week 0), post-intervention (week 13 after session 24)Physical Activity Group Environment Questionnaire: 21 items on 9-point scale. Higher scores = more social connection. The community social participation scale will be used as a covariate when analyzing this scale.
Falls risk changeBaseline (week 0), post-intervention (week 13 after session 24)Falls efficiency scale, 16-item and 4-point scale. Lower score equates to more fear of falling and less confident during daily activities.
Heart rate variability changeBaseline (week 0), post-intervention (week 13 after session 24)Measured through deep breathing protocol with electrocardiography (ECG)

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026