The Effects of a Hungarian Multidomain Lifestyle Intervention on Brain Health in Older Adults
NCT06616285, Not applicable, Unknown, Research Centre for Natural Sciences
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | The Effects of a Hungarian Multidomain Lifestyle Intervention on Brain Health in Older Adults | ClinicalTrials.gov |
| NCT number | NCT06616285 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 80 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Research Centre for Natural Sciences | ClinicalTrials.gov |
| Conditions | Neurocognitive Aging, Healthy Aging | ClinicalTrials.gov |
| Interventions | Self-Guided Multidomain Lifestyle Intervention, Folk Dance Multidomain Lifestyle Intervention | ClinicalTrials.gov |
| First posted | 2024-09-27 | ClinicalTrials.gov |
| Last updated | 2025-05-18 | ClinicalTrials.gov |
Registered outcomes 36
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Changes in Brain Functional Connectivity Measured with Resting-State fMRI | Baseline, 6 month | 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. | ClinicalTrials.gov |
| Primary | Changes in Brain Function Measured with Resting-State EEG | Baseline, 6 month | 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. | ClinicalTrials.gov |
| Secondary | Connectivity Changes in Brain Reward System | Baseline, 6 month | Cortical and subcortical resting-state multi-echo fMRI effective connectivity of brain regions associated with reward and motivation will be estimated using dynamic causal modelling. | ClinicalTrials.gov |
| Secondary | Connectivity Changes in the Brain's Default Mode Network | Baseline, 6 month | Cortical and subcortical resting-state multi-echo fMRI effective connectivity of the default mode network will be estimated using dynamic causal modelling. | ClinicalTrials.gov |
| Secondary | Changes in Hippocampal Volume | Baseline, 6 month | The volumes of the hippocampal subfields will be computed using proton density-weighted MRI. | ClinicalTrials.gov |
| Secondary | Changes in the Striatal Volume | Baseline, 6 month | The volumes of the striatal nuclei will be derived from T1 weighted MRI. | ClinicalTrials.gov |
| Secondary | Changes in the Volume of Neuromodulatory Nuclei | Baseline, 6 month | The integrity of the substantia nigra-ventral tegmental area (SN-VTA) and locus coeruleus (LC) will be computed based on magnetization transfer-weighted MRI. | ClinicalTrials.gov |
| Secondary | Changes in Brain Age | Baseline, 6 month | Individual brain age will be estimated using T1-weighted MRI images utilising pre-trained deep neural networks specifically trained for brain age prediction. | ClinicalTrials.gov |
| Secondary | Changes Resting-State EEG Frequency Band Ratio Measures | Baseline, 6 month | The relative contribution of resting-state EEG frequency band measures will be computed (alpha, beta, delta, theta frequency bands). | ClinicalTrials.gov |
| Secondary | Changes in Feedback-Related EEG and Pupil Responses | Baseline, 6 month | Changes in feedback-related EEG (early and late feedback components, P300 and Error-related Negativity ERPs) and pupil responses will be measured during the Probabilistic Reversal Learning Task. During this task, participants have to choose between two abstract symbols. In the reward condition, participants receive positive (reward, +1 point) and neutral (zero point) feedback. In the punishment conditions, participants receive negative (punishment, -1 point) or neutral feedback. Participants complete 2 blocks of 80 trials of each condition (a total of 320 trials). In any given trial, one symbol is associated with a high (80%) and the other with a low (20%) probability of reward or lack of punishment. A reversal in reward contingencies is introduced 3-7 times per block. Participants are instructed to maximise the number of points earned throughout the experiment and are financially compensated based on their performance in the task. | ClinicalTrials.gov |
| Secondary | Changes in Subjective Cost of Cognitive Effort | Baseline, 6 month | Changes in the subjective cost of cognitive effort will be measured using the Cognitive Effort Discounting Paradigm. | ClinicalTrials.gov |
| Secondary | Changes in Global Cognitive Function | Baseline, 6 month | Global cognitive function will be assessed using a composite score, which will be derived from a series of neuropsychological tests, including Verbal Episodic Memory Test, Location Learning Test, Digit Span, Verbal Fluency, Trail-Making Test, Victoria Stroop Test, and Digit Symbol Substitution Test. Scores from each test will be transformed into z-scores and then averaged to create a composite score. Higher scores indicate better performance. | ClinicalTrials.gov |
| Secondary | Changes in Episodic Memory | Baseline, 6 month | Episodic Memory will be a composite score obtained from the Verbal Episodic Memory Test and the Location Learning Test. The Episodic Memory composite is calculated in the same way as the composite score for global cognitive function. | ClinicalTrials.gov |
| Secondary | Changes in Executive Function | Baseline, 6 month | Executive Function will be a composite score obtained from Digit Span, Digit Symbol Substitution, Trail Making Test Part B, Victoria Stroop Test, and Verbal Fluency. The Executive Function composite is calculated in the same way as the composite score for global cognitive function. | ClinicalTrials.gov |
| Secondary | Changes in Processing Speed | Baseline, 6 month | Processing Speed will be a composite score obtained from Digit Symbol Substitution and Trail Making Test Part A. The Processing Speed composite is calculated in the same way as the composite score for global cognitive function. | ClinicalTrials.gov |
| Secondary | Changes in Blood Biomarkers | Baseline, 6 month | Inflammatory cytokines, C-reactive protein, glial fibrillary acidic protein, Clustering, Brain Derived Neurotrophic factor, Insulin Growth Factor-1 | ClinicalTrials.gov |
| Secondary | Changes in Anthropometry | Baseline, 6 month | Waist circumference (cm) will be measured. | ClinicalTrials.gov |
| Secondary | Changes in Body Mass Index (BMI) | Baseline, 6 month | Body Mass Index (BMI) is a measure of body fat based on height and weight for adult men and women. BMI will be expressed in kg/m\^2. | ClinicalTrials.gov |
| Secondary | Changes in Systolic Blood Pressure | Baseline, 6 month | Systolic blood pressure (mmHg) will be recorded using calibrated blood pressure monitors. | ClinicalTrials.gov |
| Secondary | Changes in Diastolic Blood Pressure | Baseline, 6 month | Diastolic blood pressure (mmHg) will be recorded using calibrated blood pressure monitors. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 2
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 8
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Digit Span Test | Secondary outcome | ConductCognition |
| Effort Discounting Task | Secondary outcome | ConductCognition |
| Probabilistic Reversal Learning | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)