Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06616285
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
The Effects of a Hungarian Multidomain Lifestyle Intervention on Brain Health in Older Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effects of a Hungarian Multidomain Lifestyle Intervention on Brain Health in Older Adults
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HUN-MLI-BRAIN
Brief Summary:
Maintaining brain health in older adults is a critical social and economic challenge given the rising prevalence of neurodegenerative disorders Despite extensive research effective pharmacological treatments for dementia remain limited emphasising the need for early diagnosis and prevention of cognitive decline Research suggests that lifestyle and modifiable factors account for approximately 40 of dementia risk highlighting the potential of personalised lifestyle interventions to delay or prevent the onset of dementia The original FINGER study demonstrated that a multi-domain lifestyle intervention simultaneously targeting dietary habits physical and cognitive activity as well as social interactions can effectively prevent cognitive decline and dementia
The HUN-MLI-BRAIN trial investigates the impact of a Hungarian lifestyle intervention on brain health in older adults and is based on the FINGER multi-domain intervention This randomised controlled study aims to maintain and enhance neurocognitive function and prevent cognitive decline in older adults through a multi-domain lifestyle program which simultaneously targets dietary habits physical and cognitive activity and social engagement
The primary goal of the HUN-MLI-BRAIN trial is to evaluate the impact of the intervention programme on neurocognitive functions and adaptive changes in large-scale brain networks at the individual level using the precision structural and functional MRI methods as well as resting-state EEG frequency-domain analyses In addition the influence of the intervention will be assessed in a wide range of cognitive and personal domains The potential relationship between brain structure and function cognitive performance lifestyle factors and dementia risk factors will be evaluated
80 people without substantial cognitive impairment or dementia will be recruited into the programme in Budapest Hungary Participants will be randomly allocated 11 either to the multi-domain folk dancing lifestyle intervention group or the self-guided multi-domain lifestyle intervention group The self-guided intervention encompasses multi-domain lifestyle recommendations on diet physical and mental training and health checks The folk dancing intervention includes structured one-hour folk dancing sessions three times per week which were specifically developed to foster physical and cognitive function whilst facilitating social interaction Participants in this group will also receive intensive and tailored lifestyle recommendations aimed at improving physical and mental functioning The duration of the intervention programme is 6 months Participants will complete assessment visits before and after the intervention
The HUN-MLI-BRAIN trial holds significant potential for advancing our understanding of how lifestyle interventions may impact brain function The use of advanced precision neuroimaging techniques will offer novel insights into the adaptive changes in brain networks and potentially lead to more effective personalised interventions for maintaining brain health in older adults
The HUN-MLI-BRAIN trial investigates the impact of a Hungarian lifestyle intervention on brain health in older adults and is based on the FINGER multi-domain intervention This randomised controlled study aims to maintain and enhance neurocognitive function and prevent cognitive decline in older adults through a multi-domain lifestyle program which simultaneously targets dietary habits physical and cognitive activity and social engagement
The primary goal of the HUN-MLI-BRAIN trial is to evaluate the impact of the intervention programme on neurocognitive functions and adaptive changes in large-scale brain networks at the individual level using the precision structural and functional MRI methods as well as resting-state EEG frequency-domain analyses In addition the influence of the intervention will be assessed in a wide range of cognitive and personal domains The potential relationship between brain structure and function cognitive performance lifestyle factors and dementia risk factors will be evaluated
80 people without substantial cognitive impairment or dementia will be recruited into the programme in Budapest Hungary Participants will be randomly allocated 11 either to the multi-domain folk dancing lifestyle intervention group or the self-guided multi-domain lifestyle intervention group The self-guided intervention encompasses multi-domain lifestyle recommendations on diet physical and mental training and health checks The folk dancing intervention includes structured one-hour folk dancing sessions three times per week which were specifically developed to foster physical and cognitive function whilst facilitating social interaction Participants in this group will also receive intensive and tailored lifestyle recommendations aimed at improving physical and mental functioning The duration of the intervention programme is 6 months Participants will complete assessment visits before and after the intervention
The HUN-MLI-BRAIN trial holds significant potential for advancing our understanding of how lifestyle interventions may impact brain function The use of advanced precision neuroimaging techniques will offer novel insights into the adaptive changes in brain networks and potentially lead to more effective personalised interventions for maintaining brain health in older adults
Detailed Description:
Participants will first complete a short phone call designed to screen for eligibility and exclusion criteria Selected participants will be invited for an in-house assessment during which they will be further screened for cognitive physical and lifestyle risk factors as well as MRI scanning compatibility Using the Mini-Mental State Examination a board-certified neurologist will also screen participants for cognitive impairment
Participants will be invited for several baseline and post-intervention assessments on separate days First eligible participants will complete a complex cognitive assessment Next EEG and pupillometry data will be collected from participants during rest and the completion of a probabilistic reversal learning task which evaluates reinforcement learning behaviour and related neural mechanisms Crucially participants will also complete structural and functional MRI assessments Using precision resting-state functional MRI the study will examine large-scale brain network segregation as well as network-specific within and cross-network connectivity changes which are known to be affected by ageing and neuropsychiatric diseases A novel multi-echo multiband sequence with enhanced BOLD signal sensitivity and reduced image artefacts will be employed to improve test-retest reliability During data collection special care will be taken to ensure the availability of a sufficient amount of clean resting-state fMRI data which is essential to ensure the accuracy and validity of the findings Finally blood samples will be collected from each participant
Following all baseline assessments participants will be randomised into the folk dancing or self-guided lifestyle intervention groups Block-randomisation will be computerised with a targeted assignment ratio of 11 and stratification for age and sex
Participants will be invited for several baseline and post-intervention assessments on separate days First eligible participants will complete a complex cognitive assessment Next EEG and pupillometry data will be collected from participants during rest and the completion of a probabilistic reversal learning task which evaluates reinforcement learning behaviour and related neural mechanisms Crucially participants will also complete structural and functional MRI assessments Using precision resting-state functional MRI the study will examine large-scale brain network segregation as well as network-specific within and cross-network connectivity changes which are known to be affected by ageing and neuropsychiatric diseases A novel multi-echo multiband sequence with enhanced BOLD signal sensitivity and reduced image artefacts will be employed to improve test-retest reliability During data collection special care will be taken to ensure the availability of a sufficient amount of clean resting-state fMRI data which is essential to ensure the accuracy and validity of the findings Finally blood samples will be collected from each participant
Following all baseline assessments participants will be randomised into the folk dancing or self-guided lifestyle intervention groups Block-randomisation will be computerised with a targeted assignment ratio of 11 and stratification for age and sex
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None