Multidomain lifestyle intervention: A multidomain lifestyle intervention, including (1) physical activity, (2) cognitive training, (3) cardiovascular risk factor management (Cardiovascular), (4) dietary counselling, (5) Souvenaid, (6) sleep counselling, (7) stress management, and (8) social activities.
Study summary
FINGER-NL is a multi-center, randomized, controlled, multidomain lifestyle intervention trial among 1,206 older adults at risk for cognitive decline with a duration of 24 months. Participants are randomized in a 1:1 ratio to a personalized multi-domain lifestyle intervention (high-intensity intervention group) versus online access to general lifestyle-related health information (low-intensity intervention group). After the intervention period, participants are invited for a 24 month extension of follow-up.
Eligibility
Sex
ALL
Min age
60 Years
Max age
79 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* 60-79 years of age at pre-screening;
* Adequate fluency in Dutch to understand the informed consent and complete questionnaires;
* Providing informed consent to all study procedures;
* Internet access at home;
* Presence of ≥3 self-reported risk factors for cognitive decline (must contain at least 2 modifiable risk factors and 1 non-modifiable riskfactor).
Exclusion Criteria:
* Diagnosis of dementia or mild cognitive impairment at baseline (self-reported);
* Significant cognitive impairment assessed using the Modified Telephone Interview for Cognitive Status battery (TICSm score\<23);
* Conditions affecting safe and continuous engagement in the intervention (e.g. under treatment for current malignant diseases, major psychiatric disorders (e.g. major depression, psychosis, bipolar disorder), neurological disorders (e.g. Parkinson's disease, multiple sclerosis), symptomatic cardiovascular disease (e.g. stroke, angina pectoris, heart failure, myocardial infarction), re-vascularization within three months, severe loss of vision, hearing or communicative ability, severe mobility impairment, other conditions preventing co-operation) as judged by the local study nurse or consulted physician at the local study site;
* Coincident participation in any other intervention trial at time of pre-screening.
* Coincident participation of spouse in FINGER-NL trial.
Primary outcome measure(s)
2-year change from baseline in global cognitive composite score — 2 years (measured at baseline, follow-up 1 and follow-up 2) Global cognitive composite score derived from subtest scores from the Neuropsychological Test Battery (NTB) that includes 15-Word Verbal Learning Test delayed recall (discrete number; 0-15 (higher score means a better outcome)), Digit Symbol Substitution Test 90 seconds (discrete number; 0-90 (higher score means a better outcome)), WAIS digit span backwards (discrete number; 0-14 (higher score means a better outcome)), and semantic fluency (discrete number; 0-no maximum, higher score means a better outcome)).
Trial sites (5)
Facility
City
Region
Status
Alzheimer Center Amsterdam
Amsterdam
Netherlands
University Medical Center Groningen
Groningen
Netherlands
Maastricht University
Maastricht
Netherlands
Radboud University
Nijmegen
Netherlands
Wageningen Unversity and Research
Wageningen
Netherlands
More Alzheimercentrum Amsterdam trials in the Netherlands
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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