Aging WellNCT05511259
Assessing Causality of the Association Between Exercise and Neurocognitive Gains
A study testing exercise in people with Aging Well, run by Nanyang Technological University at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging Well
- What is being tested?
- exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteSingapore
- Study dates
- 10 May 2022to 4 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Older adults aged 55-80
- Sedentary, defined as exercise less than 3 times per week for 30 minutes
Who cannot join
- 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
Show all 25Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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].
- Conditions
- Aging Well
- Being tested
- exercise
- Keywords
- healthy aging, older adults, cognition, exercise, neuroplasticity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
Square stepping exercise
| Study group | Role | What they receive |
|---|---|---|
| Exercise-Cognition | Experimental | Square Stepping Exercise Receives: Other: exercise |
| No exercise | No intervention | Passive control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Go-No-Go task change
Error rate: Number of "Go" responses on "No-Go" trials.
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline (week 0), post-intervention (week 13 after session 24)
Temporal gait parameters change
11-meter gait test to examine gait speed
Measured: Baseline (week 0), post-intervention (week 13 after session 24)
Motor learning change
Probabilistic Serial Reaction Time Task: learning index, computed using reaction time
Measured: Baseline (week 0), post-intervention (week 13 after session 24)
Secondary outcomes (9)
Change in cortical thickness
T1 and T2 weighted images
Measured: Baseline (week 0), post-intervention (week 13 after session 24)
Change in grey matter volume
T1 and T2 weighted images
Measured: Baseline (week 0), post-intervention (week 13 after session 24)
Change in structural topography
T1 and T2 weighted images
Measured: Baseline (week 0), post-intervention (week 13 after session 24)
Change in white matter integrity
Diffusion Tensor Imaging
Measured: Baseline (week 0), post-intervention (week 13 after session 24)
Change in white matter connectivity
Diffusion Tensor Imaging
Measured: Baseline (week 0), post-intervention (week 13 after session 24)
Change in functional connectivity
Resting state functional magnetic resonance imaging
Measured: 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
Measured: 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)
Measured: Baseline (week 0), post-intervention (week 13 after session 24)
Brain plasticity changes
Changes in power spectral density and coherence recorded from electroencephalography (EEG)
Measured: Baseline (week 0), post-intervention (week 13 after session 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start10 May 2022
- Primary completion4 Apr 2023
- Study completion4 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aging WellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group: 3-month community based exercise program (square stepping exercise)
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanyang Technological University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SH Annabel Chen, PhD, Nanyang Technological University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511259
- Sponsor's protocol ID
- MOE2019-T2-1-019
- Status last verified
- Aug 2022
- First submitted
- 14 Mar 2022
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only de-identified data will be shared after publication and upon request. Request for data needs to justify use of data.
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Causality of the Association Between Exercise and Neurocognitive Gains
- ClinicalTrials.gov ID
- NCT05511259
- Acronym / sponsor ID
- MOE2019-T2-1-019
- Conditions
- Aging Well
- Keywords
- healthy aging, older adults, cognition, exercise, neuroplasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Nanyang Technological UniversityUniversity, hospital or other
- Study start
- 10 May 2022 (actual)
- Primary completion
- 4 Apr 2023 (actual)
- Study completion
- 4 Apr 2023 (actual)
- First posted
- 22 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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].
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention group: 3-month community based exercise program (square stepping exercise)
| Arm | Type | Receives |
|---|---|---|
| Exercise-Cognition | Experimental | Other: exerciseSquare Stepping Exercise |
| No exercise | No intervention | –Passive control group |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Older adults aged 55-80
- Sedentary, defined as exercise less than 3 times per week for 30 minutes
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exerciseSquare stepping exercise | Other | Exercise-Cognition |
Primary outcome
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.
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.
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)
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
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
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
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
Temporal gait parameters change
Time frame: Baseline (week 0), post-intervention (week 13 after session 24)
11-meter gait test to examine gait speed
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
9 secondary outcomes
Change in cortical thickness
Time frame: Baseline (week 0), post-intervention (week 13 after session 24)
Change in grey matter volume
Time frame: Baseline (week 0), post-intervention (week 13 after session 24)
Change in structural topography
Time frame: Baseline (week 0), post-intervention (week 13 after session 24)
Change in white matter integrity
Time frame: Baseline (week 0), post-intervention (week 13 after session 24)
Change in white matter connectivity
Time frame: Baseline (week 0), post-intervention (week 13 after session 24)
Change in functional connectivity
Time frame: Baseline (week 0), post-intervention (week 13 after session 24)
Brain plasticity changes
Time frame: Baseline (week 0), post-intervention (week 13 after session 24)
Brain plasticity changes
Time frame: Baseline (week 0), post-intervention (week 13 after session 24)
Brain plasticity changes
Time frame: Baseline (week 0), post-intervention (week 13 after session 24)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Individual participant dataSharing planned: Yes. Only de-identified data will be shared after publication and upon request. Request for data needs to justify use of data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Aging Well, run by Nanyang Technological University at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Go-No-Go task change (time frame: Baseline (week 0), mid-intervention (week 7 after session 12), post-intervention (week 13 after session 24)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.