- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT05511259
Assessing Causality of the Association Between Exercise and Neurocognitive Gains
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.
Přehled studie
Detailní popis
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].
Typ studie
Zápis (Očekávaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: S.H Annabel Chen, PhD
- Telefonní číslo: +65 69081457
- E-mail: annabelchen@ntu.edu.sg
Studijní záloha kontaktů
- Jméno: Masato Kawabata, PhD
- Telefonní číslo: +65 67903702
- E-mail: masato.kawabata@nie.edu.sg
Studijní místa
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Singapore, Singapur
- Nábor
- Nanyang Technological University
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Kontakt:
- S.H. Annabel Chen, PhD
- Telefonní číslo: +65 69081457
- E-mail: annabelchen@ntu.edu.sg
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Základní věda
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Žádný zásah: Řízení
Skupina pasivní kontroly
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Experimentální: Intervention
Square stepping exercise
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Square stepping exercise
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Go-No-Go task change
Časové okno: 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.
|
Baseline (week 0), mid-intervention (week 7 after session 12), post-intervention (week 13 after session 24)
|
Stroop task colour words and colour blocks
Časové okno: 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.
|
Baseline (week 0), mid-intervention (week 7 after session 12), post-intervention (week 13 after session 24)
|
N-Back task change
Časové okno: Baseline (week 0), mid-intervention (week 7 after session 12), post-intervention (week 13 after session 24)
|
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
Časové okno: 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
|
Baseline (week 0), mid-intervention (week 7 after session 12), post-intervention (week 13 after session 24)
|
Digit Span task change
Časové okno: 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
|
Baseline (week 0), mid-intervention (week 7 after session 12), post-intervention (week 13 after session 24)
|
Modified Card Sorting task change
Časové okno: Baseline (week 0), mid-intervention (week 7 after session 12), post-intervention (week 13 after session 24)
|
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
Časové okno: Baseline (week 0), post-intervention (week 13 after session 24)
|
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
Časové okno: Baseline (week 0), post-intervention (week 13 after session 24)
|
11-meter gait test to examine gait speed
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Baseline (week 0), post-intervention (week 13 after session 24)
|
Motor learning change
Časové okno: Baseline (week 0), post-intervention (week 13 after session 24)
|
Probabilistic Serial Reaction Time Task: learning index, computed using reaction time
|
Baseline (week 0), post-intervention (week 13 after session 24)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Change in cortical thickness
Časové okno: Baseline (week 0), post-intervention (week 13 after session 24)
|
T1 and T2 weighted images
|
Baseline (week 0), post-intervention (week 13 after session 24)
|
Change in grey matter volume
Časové okno: Baseline (week 0), post-intervention (week 13 after session 24)
|
T1 and T2 weighted images
|
Baseline (week 0), post-intervention (week 13 after session 24)
|
Change in structural topography
Časové okno: Baseline (week 0), post-intervention (week 13 after session 24)
|
T1 and T2 weighted images
|
Baseline (week 0), post-intervention (week 13 after session 24)
|
Change in white matter integrity
Časové okno: Baseline (week 0), post-intervention (week 13 after session 24)
|
Diffusion Tensor Imaging
|
Baseline (week 0), post-intervention (week 13 after session 24)
|
Change in white matter connectivity
Časové okno: Baseline (week 0), post-intervention (week 13 after session 24)
|
Diffusion Tensor Imaging
|
Baseline (week 0), post-intervention (week 13 after session 24)
|
Change in functional connectivity
Časové okno: Baseline (week 0), post-intervention (week 13 after session 24)
|
Resting state functional magnetic resonance imaging
|
Baseline (week 0), post-intervention (week 13 after session 24)
|
Brain plasticity changes
Časové okno: 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
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Baseline (week 0), post-intervention (week 13 after session 24)
|
Brain plasticity changes
Časové okno: Baseline (week 0), post-intervention (week 13 after session 24)
|
Changes in transcranial magnetic stimulation (TMS)-evoked potentials recorded from electroencephalography (EEG)
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Baseline (week 0), post-intervention (week 13 after session 24)
|
Brain plasticity changes
Časové okno: Baseline (week 0), post-intervention (week 13 after session 24)
|
Changes in power spectral density and coherence recorded from electroencephalography (EEG)
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Baseline (week 0), post-intervention (week 13 after session 24)
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Subjective vitality scale change
Časové okno: Baseline (week 0), post-intervention (week 13 after session 24)
|
5-item vitality score (7-point scale, higher score greater wellbeing outcome)
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Baseline (week 0), post-intervention (week 13 after session 24)
|
Heart rate variability change
Časové okno: Baseline (week 0), post-intervention (week 13 after session 24)
|
Measured through deep breathing protocol with electrocardiography (ECG)
|
Baseline (week 0), post-intervention (week 13 after session 24)
|
Falls risk change
Časové okno: 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.
|
Baseline (week 0), post-intervention (week 13 after session 24)
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Social engagement and cohesion
Časové okno: 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.
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Baseline (week 0), post-intervention (week 13 after session 24)
|
Change in mood (related to movement)
Časové okno: 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.
|
Baseline (week 0), post-intervention (week 13 after session 24)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- MOE2019-T2-1-019
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