NCT05511259

Brief Summary

Brief Summary: The aim of this project is to examine:

  1. 1.The effects of a community based square stepping exercise programme on cognitive and physical functions in older adults.
  2. 2.The effects of a community based square stepping exercise programme on neuroplasticity in older adults.
  3. 3.The effects of a community based square stepping exercise programme on structural and functional brain changes in older adults.
  4. 4.The relationship between exercise-induced changes in neuroplasticity, structural and functional brain activations, and cognitive and physical gains in older adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

May 10, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 22, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2023

Completed
Last Updated

May 31, 2025

Status Verified

August 1, 2022

Enrollment Period

11 months

First QC Date

March 14, 2022

Last Update Submit

May 27, 2025

Conditions

Keywords

healthy agingolder adultscognitionexerciseneuroplasticity

Outcome Measures

Primary Outcomes (9)

  • 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 Outcomes (9)

  • Change in cortical thickness

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

  • Change in grey matter volume

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

  • Change in structural topography

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

  • Change in white matter integrity

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

  • Change in white matter connectivity

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

  • +4 more secondary outcomes

Other Outcomes (5)

  • Subjective vitality scale change

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

  • Heart rate variability change

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

  • Falls risk change

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

  • +2 more other outcomes

Study Arms (2)

Exercise-Cognition

EXPERIMENTAL

Square Stepping Exercise

Other: exercise

No exercise

NO INTERVENTION

Passive control group

Interventions

Square stepping exercise

Exercise-Cognition

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Older adults aged 55-80
  • Sedentary, defined as exercise less than 3 times per week for 30 minutes

You may not qualify if:

  • 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.
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanyang Technological University

Singapore, Singapore

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Intervention group: 3-month community based exercise program (square stepping exercise)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology, School of Social Sciences

Study Record Dates

First Submitted

March 14, 2022

First Posted

August 22, 2022

Study Start

May 10, 2022

Primary Completion

April 4, 2023

Study Completion

April 4, 2023

Last Updated

May 31, 2025

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

Only de-identified data will be shared after publication and upon request. Request for data needs to justify use of data.

Shared Documents
STUDY PROTOCOL
Time Frame
6 months after publication
Access Criteria
Request needs to be made to the PI with clear plan for the use of data.

Locations