Ignite Creation Date:
2024-05-06 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 2:20 PM
Study NCT ID:
NCT05163769
Status:
UNKNOWN
Last Update Posted:
2022-07-28
First Post:
2021-12-07
Brief Title:
Physical and Cognitive Training System for Neurocognitive Protection and Enhancement in Older Adults
Sponsor:
Duke-NUS Graduate Medical School
Organization:
Duke-NUS Graduate Medical School
Study Overview
Official Title:
The Efficacy of a Novel Multimodal Personalized Physical and Cognitive Training System for Neurocognitive Protection and Enhancement in Older Adults
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Neurocognitive decline is a health issue that is associated with ageing It is often irreversible from the onset The concomitant costs of neurocognitive decline could be potentially exponential if left unchecked Therefore there is a need to be able to delay the onset of age-related neurocognitive decline or possibly avoid it altogether Previous studies have shown that there is a strong positive relationship between the fitness of neurocognitive function and cognitive training More interestingly recent studies also suggest that combining cognitive training with physical activity may result in a better outcome for neurocognitive function as compared to only cognitive training Anchoring on the findings of those studies the investigators aim to develop and evaluate the efficacy of a novel personalized multimodal brain computer interface BCI cognitive and physical training system for neurocognitive protection and enhancement in older adults The current study employs a three-arm randomized-controlled trial approach The investigators hypothesize that participants in the multimodal cognitive and physical training mBCI group will perform significantly better than the cognitive training-only BCI nBCI and active control AC groups on the Repeated Battery for the Assessment of Neuropsychological Status RBANS after an initial high-intensity 36 training session period from pre- to 12 weeks post-intervention The investigators also hypothesize that the mBCI group will perform significantly better on the RBANS than nBCI or AC groups after the consecutive high- and low-intensity periods from pre- to 24-weeks post-intervention
Detailed Description:
Neurocognitive decline is a health problem that is associated with ageing More often than not age-related cognitive decline may be indicative of the onset of mild cognitive impairment MCI or even more severe neurocognitive disorders such as Alzheimers and Parkinsons disease-both of which will eventually lead to dementia Cognitive decline and neurocognitive disorders can often lead to the gross deterioration in ones quality of life Depending on the severity and duration of the onset of the neurocognitive decline patients may experience anything from forgetfulness or learning difficulties to major issues such as a decreased capacity for decision-making confusion disorientation communication problems and social behavioral issues All of these issues could impede ones ability to care for ones self which may also lead to the increased reliance and burden on caretakers
On a global scale it is estimated that about 468 million people suffer from dementia or other dementia subtypes That number is expected to increase by 68 over the next 30 years The current economic burden of dementia and other dementia subtypes is evaluated at 818 billion with projections expecting cost to rise to 2 trillion by the year 2030 In Singapore specifically the estimated cost of dementia was reported at 14 billion per year with costs expecting to rise in tandem with Singapores rapidly aging population Given the impact and impending threats of neurocognitive decline it is clear that intentional efforts to combat neurocognitive decline is necessary
To date experts in the field have yet to identify specific causes of neurocognitive decline This is due to the heterogeneity of neurocognitive decline and the diseases associated with it As such it has been challenging to find definitive causes and cures for neurocognitive decline That said there are several risk factors associated with neurocognitive decline and dementia Risk factors such as age and genetics are fairly predictive of neurocognitive decline but are by nature unmodifiable However risk factors such as but not limited to cardiovascular problems physical activity cognitive training and social engagement are possible and much easier to modify Hence there has been a preponderance of interventions in the field that targets those specific modifiable risk factors with the intention of manipulating current or future neurocognitive outcomes For example cognitive training CT has been a target for interventions that promote the delay andor prevention of neurocognitive decline Over the past few decades CT programs in the field have evolved to computerized gamified and self-manned versions that usually target specific areas of cognition such as memory attention decision-making inhibition or a combination of those areas
Similarly physical activity PA has also been a target for interventions that promote the delay andor prevention of neurocognitive decline Studies with PA-specific interventions have also shown to positively influence neurocognitive function in patients with mild cognitive impairment as well as those who are at risk of developing Alzheimers Disease Evidence also show that PA can delay the effects of neurocognitive decline in patients with existing cognitive decline dementia and other dementia subtypes
Interestingly there has been a recent surge of interventions in the field that amalgamates both PA and CT elements This shift in direction in the field acknowledges the symbiotic relationship between CT and PA with regards to neurocognitive outcome Many of these studies set out to investigate the effects of exergaming a portmanteau of exercise and gaming on neurocognitive function in the older adult population with varying neurocognitive capacity ranging from healthy to declining Exergaming interventions have shown to improve the subjects executive function and cognitive performance after the intervention period as compared to the subject controls The effects of exergaming interventions were also able to delay the onset of mild cognitive impairment in healthy subjects as compared to the healthy controls in some studies That said such programs are still limited by factors such as poor personalization capabilities substandard controls and high attrition rates lack of participant engagement Additionally studies of such nature are far and few between in Asia making it unclear if similar results can be replicated in an Asian-majority demographic like Singapore
To address these issues the current study aims to use a novel personalized multimodal physical and cognitive brain computer interface BCI training system to delay andor prevent neurocognitive decline and enhance neurocognitive function The investigators proposed training system integrates a stationary cycling intervention and a corresponding personalized BCI cognitive training program The BCI cognitive training program uses machine learning technologies and elderly-friendly user-interfaceuser-experience UIUX game design to actively track individual neurocognitive status provide feedback in real-time and encourage older adults to persist in training for the long term The investigators also seek to customize the programs UIUX by employing locally-relevant materials to reduce accessibility barriers and increase participant engagement For the purposes of this study all instructions and interventions will be delivered in English However there are plans for future iterations of this program to include other local languages to facilitate the use of the program by non-English speaking Singaporean elderly
On a global scale it is estimated that about 468 million people suffer from dementia or other dementia subtypes That number is expected to increase by 68 over the next 30 years The current economic burden of dementia and other dementia subtypes is evaluated at 818 billion with projections expecting cost to rise to 2 trillion by the year 2030 In Singapore specifically the estimated cost of dementia was reported at 14 billion per year with costs expecting to rise in tandem with Singapores rapidly aging population Given the impact and impending threats of neurocognitive decline it is clear that intentional efforts to combat neurocognitive decline is necessary
To date experts in the field have yet to identify specific causes of neurocognitive decline This is due to the heterogeneity of neurocognitive decline and the diseases associated with it As such it has been challenging to find definitive causes and cures for neurocognitive decline That said there are several risk factors associated with neurocognitive decline and dementia Risk factors such as age and genetics are fairly predictive of neurocognitive decline but are by nature unmodifiable However risk factors such as but not limited to cardiovascular problems physical activity cognitive training and social engagement are possible and much easier to modify Hence there has been a preponderance of interventions in the field that targets those specific modifiable risk factors with the intention of manipulating current or future neurocognitive outcomes For example cognitive training CT has been a target for interventions that promote the delay andor prevention of neurocognitive decline Over the past few decades CT programs in the field have evolved to computerized gamified and self-manned versions that usually target specific areas of cognition such as memory attention decision-making inhibition or a combination of those areas
Similarly physical activity PA has also been a target for interventions that promote the delay andor prevention of neurocognitive decline Studies with PA-specific interventions have also shown to positively influence neurocognitive function in patients with mild cognitive impairment as well as those who are at risk of developing Alzheimers Disease Evidence also show that PA can delay the effects of neurocognitive decline in patients with existing cognitive decline dementia and other dementia subtypes
Interestingly there has been a recent surge of interventions in the field that amalgamates both PA and CT elements This shift in direction in the field acknowledges the symbiotic relationship between CT and PA with regards to neurocognitive outcome Many of these studies set out to investigate the effects of exergaming a portmanteau of exercise and gaming on neurocognitive function in the older adult population with varying neurocognitive capacity ranging from healthy to declining Exergaming interventions have shown to improve the subjects executive function and cognitive performance after the intervention period as compared to the subject controls The effects of exergaming interventions were also able to delay the onset of mild cognitive impairment in healthy subjects as compared to the healthy controls in some studies That said such programs are still limited by factors such as poor personalization capabilities substandard controls and high attrition rates lack of participant engagement Additionally studies of such nature are far and few between in Asia making it unclear if similar results can be replicated in an Asian-majority demographic like Singapore
To address these issues the current study aims to use a novel personalized multimodal physical and cognitive brain computer interface BCI training system to delay andor prevent neurocognitive decline and enhance neurocognitive function The investigators proposed training system integrates a stationary cycling intervention and a corresponding personalized BCI cognitive training program The BCI cognitive training program uses machine learning technologies and elderly-friendly user-interfaceuser-experience UIUX game design to actively track individual neurocognitive status provide feedback in real-time and encourage older adults to persist in training for the long term The investigators also seek to customize the programs UIUX by employing locally-relevant materials to reduce accessibility barriers and increase participant engagement For the purposes of this study all instructions and interventions will be delivered in English However there are plans for future iterations of this program to include other local languages to facilitate the use of the program by non-English speaking Singaporean elderly
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None