Assessing Causality of the Association Between Exercise and Neurocognitive Gains

NCT ID: NCT05511259

Last Updated: 2025-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-10

Study Completion Date

2023-04-04

Brief Summary

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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

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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 \[anticipated\].

Conditions

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Aging Well

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Exercise-Cognition

Square Stepping Exercise

Group Type EXPERIMENTAL

exercise

Intervention Type OTHER

Square stepping exercise

No exercise

Passive control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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exercise

Square stepping exercise

Intervention Type OTHER

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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nanyang Technological University

OTHER

Sponsor Role lead

Responsible Party

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SH Annabel Chen, PhD

Professor of Psychology, School of Social Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nanyang Technological University

Singapore, , Singapore

Site Status

Countries

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Singapore

Other Identifiers

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MOE2019-T2-1-019

Identifier Type: -

Identifier Source: org_study_id

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