Skip to main content
OpenTrials
Completed

NCT Number: NCT05511259

Assessing Causality of the Association Between Exercise and Neurocognitive Gains

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanyang Technological University

Singapore

About this study

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].

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise

Other

Square stepping exercise

Primary outcomes

  1. Go-No-Go task change

    Time frame: Baseline (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.

  2. Stroop task colour words and colour blocks

    Time frame: Baseline (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.

  3. N-Back task change

    Time frame: Baseline (week 0), mid-intervention (week 7 after session 12), post-intervention (week 13 after session 24)

    Number of correct responses (hits)

  4. Trail Making Test ((TMT) change

    Time frame: Baseline (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

  5. Digit Span task change

    Time frame: Baseline (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

  6. Modified Card Sorting task change

    Time frame: Baseline (week 0), mid-intervention (week 7 after session 12), post-intervention (week 13 after session 24)

    Total number of perseverative errors

  7. Static balance (single leg) change

    Time frame: Baseline (week 0), post-intervention (week 13 after session 24)

    Duration required to perform single leg stance on left and right legs

  8. Temporal gait parameters change

    Time frame: Baseline (week 0), post-intervention (week 13 after session 24)

    11-meter gait test to examine gait speed

  9. Motor learning change

    Time frame: Baseline (week 0), post-intervention (week 13 after session 24)

    Probabilistic Serial Reaction Time Task: learning index, computed using reaction time

Secondary outcomes

  1. Change in cortical thickness

    Time frame: Baseline (week 0), post-intervention (week 13 after session 24)

    T1 and T2 weighted images

  2. Change in grey matter volume

    Time frame: Baseline (week 0), post-intervention (week 13 after session 24)

    T1 and T2 weighted images

  3. Change in structural topography

    Time frame: Baseline (week 0), post-intervention (week 13 after session 24)

    T1 and T2 weighted images

  4. Change in white matter integrity

    Time frame: Baseline (week 0), post-intervention (week 13 after session 24)

    Diffusion Tensor Imaging

  5. Change in white matter connectivity

    Time frame: Baseline (week 0), post-intervention (week 13 after session 24)

    Diffusion Tensor Imaging

  6. Change in functional connectivity

    Time frame: Baseline (week 0), post-intervention (week 13 after session 24)

    Resting state functional magnetic resonance imaging

  7. Brain plasticity changes

    Time frame: Baseline (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

  8. Brain plasticity changes

    Time frame: Baseline (week 0), post-intervention (week 13 after session 24)

    Changes in transcranial magnetic stimulation (TMS)-evoked potentials recorded from electroencephalography (EEG)

  9. Brain plasticity changes

    Time frame: Baseline (week 0), post-intervention (week 13 after session 24)

    Changes in power spectral density and coherence recorded from electroencephalography (EEG)

Other outcomes

  1. Subjective vitality scale change

    Time frame: Baseline (week 0), post-intervention (week 13 after session 24)

    5-item vitality score (7-point scale, higher score greater wellbeing outcome)

  2. Heart rate variability change

    Time frame: Baseline (week 0), post-intervention (week 13 after session 24)

    Measured through deep breathing protocol with electrocardiography (ECG)

  3. Falls risk change

    Time frame: Baseline (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.

  4. Social engagement and cohesion

    Time frame: Baseline (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.

  5. Change in mood (related to movement)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Nanyang Technological University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 22, 2022
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.