Assessing Causality of the Association Between Exercise and Neurocognitive Gains

Aging Well Clinical Trial

Official title:

Assessing Causality of the Association Between Exercise and Neurocognitive Gains

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05511259
• Other study ID #: MOE2019-T2-1-019
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2022
• Est. completion date: December 2, 2023

Study information

• Verified date: August 2022
• Source: Nanyang Technological University
• Contact: S.H Annabel Chen, PhD
• Phone: 69081457
• Email: annabelchen[@]ntu.edu.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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].

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2, 2023
• Est. primary completion date: December 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aging Well

Intervention

Other:
• exercise
Square stepping exercise

Locations

Country	Name	City	State
Singapore	Nanyang Technological University	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Nanyang Technological University

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subjective vitality scale change	5-item vitality score (7-point scale, higher score greater wellbeing outcome)	Baseline (week 0), post-intervention (week 13 after session 24)
Other	Heart rate variability change	Measured through deep breathing protocol with electrocardiography (ECG)	Baseline (week 0), post-intervention (week 13 after session 24)
Other	Falls risk change	Falls efficiency scale, 16-item and 4-point scale. Lower score equates to more fear of falling and less confident during daily activities.	Baseline (week 0), post-intervention (week 13 after session 24)
Other	Social engagement and cohesion	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.	Baseline (week 0), post-intervention (week 13 after session 24)
Other	Change in mood (related to movement)	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.	Baseline (week 0), post-intervention (week 13 after session 24)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	Temporal gait parameters change	11-meter gait test to examine gait speed	Baseline (week 0), post-intervention (week 13 after session 24)
Primary	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	Change in cortical thickness	T1 and T2 weighted images	Baseline (week 0), post-intervention (week 13 after session 24)
Secondary	Change in grey matter volume	T1 and T2 weighted images	Baseline (week 0), post-intervention (week 13 after session 24)
Secondary	Change in structural topography	T1 and T2 weighted images	Baseline (week 0), post-intervention (week 13 after session 24)
Secondary	Change in white matter integrity	Diffusion Tensor Imaging	Baseline (week 0), post-intervention (week 13 after session 24)
Secondary	Change in white matter connectivity	Diffusion Tensor Imaging	Baseline (week 0), post-intervention (week 13 after session 24)
Secondary	Change in functional connectivity	Resting state functional magnetic resonance imaging	Baseline (week 0), post-intervention (week 13 after session 24)
Secondary	Brain plasticity changes	Changes in transcranial magnetic stimulation (TMS) induced motor evoked potential amplitudes in response to theta-burst stimulation protocol	Baseline (week 0), post-intervention (week 13 after session 24)
Secondary	Brain plasticity changes	Changes in transcranial magnetic stimulation (TMS)-evoked potentials recorded from electroencephalography (EEG)	Baseline (week 0), post-intervention (week 13 after session 24)
Secondary	Brain plasticity changes	Changes in power spectral density and coherence recorded from electroencephalography (EEG)	Baseline (week 0), post-intervention (week 13 after session 24)