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ACTIVE NOT RECRUITING

NCT06616285

The Effects of a Hungarian Multidomain Lifestyle Intervention on Brain Health in Older Adults

Sponsor: Research Centre for Natural Sciences

View on ClinicalTrials.gov

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 1:1 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 via the Polar Pacer smart watch. 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.

Key Details

Gender

All

Age Range

65 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-05-01

Completion Date

2025-12

Last Updated

2025-05-18

Healthy Volunteers

Yes

Conditions

Neurocognitive Aging Healthy Aging

Interventions

BEHAVIORAL

Self-Guided Multidomain Lifestyle Intervention

Participants will receive guidance on healthy dietary habits, physical activity, mental stimulation, and cardiovascular/metabolic monitoring based on national recommendations and individual consultations with the study physician. Based on this guidance, participants will create their own healthy lifestyle plan. Participants' cardiovascular/metabolic risk factors will be regularly monitored.

BEHAVIORAL

Folk Dance Multidomain Lifestyle Intervention

Participants will receive structured, intensive lifestyle intervention with the following components: diet, physical exercise, mental stimulation, cardiovascular/metabolic risk monitoring, social interaction. One-hour long folk dancing sessions, delivered by professional teachers 3 times weekly, will provide opportunities for physical and mental exercise and social interaction. These sessions were specifically developed to foster physical and mental stimulation through the learning of coordinated movement and different choreographies (rhythmic and gradually more complex movements with folk songs) individually, in pairs, and circles. As such, social stimulation is naturally embedded in the sessions. Participants will receive advice about diet and cardiovascular/metabolic risk factors based on national recommendations via group sessions and individual consultations. Participants' cardiovascular/metabolic risk factors will be regularly monitored.

Inclusion Criteria: * Age of 65-75 years * Proficiency in the local (Hungarian) language * Ability to perform all the three components of the Short Physical Performance Battery (score of at least 1 in each component) Exclusion Criteria: * Previous diagnosis of mild cognitive impairment or dementia, including current use of medications for memory impairment * Suspected mild cognitive impairment or dementia after screening assessments, based on clinical judgement * Contraindication for MRI scanning (e.g., metal implants, claustrophobia, excessive movement, etc.) * History of any significant neurological condition, including Parkinson's disease, Huntington's disease, normal pressure hydrocephalus, brain tumours, progressive supranuclear palsy, seizure disorder, subdural heamatoma, multiple sclerosis, or history of stroke, transient ischemic attack, or any significant head trauma with persistent neurologic sequelae or known structural brain abnormalities * History of major depression, bipolar disorder, schizophrenia * Chronic medication use that could reasonably affect cognition, movement, or brain imaging measures * Active substance-related and addictive disorders * Current use of narcotics and psychoactive medications * Cognitive impairment based on the Mini-Mental State Examination (MMSE, raw score less than 26) * Reduced capacity for decision-making, unable to provide consent or complete study assessments, based on clinical judgement * Conditions that prevent safe study participation * Current significant medical problems (e.g., malignant disease, cardiovascular disease, conduction disorder) * History within the last 2 years of treatment for primary or recurrent malignant disease * Poorly controlled or uncontrolled diabetes mellitus, cardiovascular, conduction, or pulmonary disease * Conditions that prevent cooperation: severe visual, auditory, or communication impairment (i.e., colour blindness, uncorrected hearing loss) * PI/Study Clinician discretion regarding medical status, suitability of participation, or concerns about adherence to intervention * Ongoing participation in another clinical intervention study

Locations (1)

Brain Imaging Centre, HUN-REN Centre for Natural Sciences

Budapest, Hungary