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

NCT06616285 | Active Not Recruiting

• 1 other identifier: 298/2/2023/HF
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Neurocognitive Aging; Healthy Aging

Keywords

Brain; Healthy Aging; Multidomain intervention; Neurocognitive Aging

Outcome Measures

Primary Outcomes (2)

• Changes in Brain Functional Connectivity Measured with Resting-State fMRI

  Multi-echo functional MRI (3T Siemens Prisma scanner) measure of individual large-scale brain network segregation as well as network-specific within and cross-network connectivity changes will be derived. Network segregation will be estimated by computing the difference between within-network connectivity and between-network connectivity, normalised by the total connectivity.

  Baseline, 6 month

• Changes in Brain Function Measured with Resting-State EEG

  Resting-state neural activity will be recorded via a 64-channel Brain Products actiCAP EEG device. Individual-level periodic and aperiodic α peak frequency will be computed.

  Baseline, 6 month

Secondary Outcomes (31)

• Connectivity Changes in Brain Reward System

  Baseline, 6 month

• Connectivity Changes in the Brain's Default Mode Network

  Baseline, 6 month

• Changes in Hippocampal Volume

  Baseline, 6 month

• Changes in the Striatal Volume

  Baseline, 6 month

• Changes in the Volume of Neuromodulatory Nuclei

  Baseline, 6 month

Other Outcomes (3)

• Demographics and medical history

  Baseline

• Instrumental Activities of Daily Living (IADL)

  Baseline

• Dementia screening

  Baseline

Study Arms (2)

Folk Dance Multidomain Lifestyle Intervention

ACTIVE COMPARATOR

Participants will receive structured, intensive lifestyle intervention through group and individual sessions. Main lifestyle components included: diet, physical exercise, mental stimulation, cardiovascular/metabolic risk monitoring, social interaction. The intervention will last for 6 months.

Behavioral: Folk Dance Multidomain Lifestyle Intervention

Self-Guided Multidomain Lifestyle Intervention

SHAM COMPARATOR

Participants will receive multi-domain lifestyle intervention that provides guidance on healthy diet, physical activity, and mental stimulation, and cardiovascular/metabolic risk factors monitoring. The intervention will last for 6 months.

Behavioral: Self-Guided Multidomain Lifestyle Intervention

Interventions

Self-Guided Multidomain Lifestyle Intervention BEHAVIORAL

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.

Self-Guided Multidomain Lifestyle Intervention

Folk Dance Multidomain Lifestyle Intervention BEHAVIORAL

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.

Folk Dance Multidomain Lifestyle Intervention

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Research Centre for Natural Sciences: lead
• HUN-REN Institute of Experimental Medicine: collaborator
• Semmelweis University: collaborator

Study Sites (1)

Brain Imaging Centre, HUN-REN Centre for Natural Sciences

Budapest, 1117, Hungary

Location

Related Publications (2)

• Barbera M, Lehtisalo J, Perera D, Aspo M, Cross M, De Jager Loots CA, Falaschetti E, Friel N, Luchsinger JA, Gavelin HM, Peltonen M, Price G, Neely AS, Thunborg C, Tuomilehto J, Mangialasche F, Middleton L, Ngandu T, Solomon A, Kivipelto M; MET-FINGER study team. A multimodal precision-prevention approach combining lifestyle intervention with metformin repurposing to prevent cognitive impairment and disability: the MET-FINGER randomised controlled trial protocol. Alzheimers Res Ther. 2024 Jan 31;16(1):23. doi: 10.1186/s13195-023-01355-x.

  PMID: 38297399 BACKGROUND

• Barbera M, Perera D, Matton A, Mangialasche F, Rosenberg A, Middleton L, Ngandu T, Solomon A, Kivipelto M. Multimodal Precision Prevention - A New Direction in Alzheimer's Disease. J Prev Alzheimers Dis. 2023;10(4):718-728. doi: 10.14283/jpad.2023.114.

  PMID: 37874092 BACKGROUND

Study Officials

• Zoltán Vidnyánszky, Ph.D., DSc.

  HUN-REN Centre for Natural Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Baseline assessments will be conducted at the research centre prior to randomisation. After baseline assessments and randomisation, two members of the research team will be unblinded to group allocation in order to coordinate the intervention. Post-intervention measurements and data analyses will be conducted by researchers and trained research assistants who are blind to participant randomisation and are not present during the intervention sessions. Participants will be instructed not to disclose their randomisation status during any of the assessment sessions or in-house visits. Participants and intervention staff will be aware of their group allocation. The intervention staff will not conduct any assessment of participants.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Brain Imaging Centre, HUN-REN Centre for Natural Sciences

Model Details: Randomised controlled trial. Participants will be randomised either into the Folk Dance Multidomain Lifestyle Intervention Group or the Self-Guided Multidomain Lifestyle Intervention Group. The intervention will be delivered over a period of 6 months.

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 27, 2024
• Study Start: May 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 18, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The trial Steering Committee and Management Group will consider applications for data after the trials results have been published and data will be made available according to the terms of the access agreement.
• Access Criteria: As described above in the Plan Description.

Locations

HU (1)