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Recruitment and baseline characteristics of participants in the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER)-a randomized controlled lifestyle trial.

ABSTRACT: Our aim is to describe the study recruitment and baseline characteristics of the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) study population. Potential study participants (age 60-77 years, the dementia risk score ? 6) were identified from previous population-based survey cohorts and invited to the screening visit. To be eligible, cognitive performance measured at the screening visit had to be at the mean level or slightly lower than expected for age. Of those invited (n = 5496), 48% (n = 2654) attended the screening visit, and finally 1260 eligible participants were randomized to the intervention and control groups (1:1). The screening visit non-attendees were slightly older, less educated, and had more vascular risk factors and diseases present. The mean (SD) age of the randomized participants was 69.4 (4.7) years, Mini-Mental State Examination 26.7 (2.0) points, systolic blood pressure 140.1 (16.2) mmHg, total serum cholesterol 5.2 (1.0) mmol/L for, and fasting glucose 6.1 (0.9) mmol/L for, with no difference between intervention and control groups. Several modifiable risk factors were present at baseline indicating an opportunity for the intervention. The FINGER study will provide important information on the effect of lifestyle intervention to prevent cognitive impairment among at risk persons.

SUBMITTER: Ngandu T

PROVIDER: S-EPMC4199023 | biostudies-literature | 2014 Sep

REPOSITORIES: biostudies-literature

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Recruitment and baseline characteristics of participants in the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER)-a randomized controlled lifestyle trial.

Ngandu Tiia T Lehtisalo Jenni J Levälahti Esko E Laatikainen Tiina T Lindström Jaana J Peltonen Markku M Solomon Alina A Ahtiluoto Satu S Antikainen Riitta R Hänninen Tuomo T Jula Antti A Mangialasche Francesca F Paajanen Teemu T Pajala Satu S Rauramaa Rainer R Strandberg Timo T Tuomilehto Jaakko J Soininen Hilkka H Kivipelto Miia M

International journal of environmental research and public health 20140910 9

Our aim is to describe the study recruitment and baseline characteristics of the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) study population. Potential study participants (age 60-77 years, the dementia risk score ≥ 6) were identified from previous population-based survey cohorts and invited to the screening visit. To be eligible, cognitive performance measured at the screening visit had to be at the mean level or slightly lower than expected for ...[more]

PMID: 25211775

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Project description:BackgroundThe Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) was a multicenter randomized controlled trial that reported beneficial effects on cognition for a 2-year multimodal intervention (diet, exercise, cognitive training, vascular risk monitoring) versus control (general health advice). This study reports exploratory analyses of brain MRI measures.MethodsFINGER targeted 1260 older individuals from the general Finnish population. Participants were 60-77 years old, at increased risk for dementia but without dementia/substantial cognitive impairment. Brain MRI scans were available for 132 participants (68 intervention, 64 control) at baseline and 112 participants (59 intervention, 53 control) at 2 years. MRI measures included regional brain volumes, cortical thickness, and white matter lesion (WML) volume. Cognition was assessed at baseline and 1- and 2-year visits using a comprehensive neuropsychological test battery. We investigated the (1) differences between the intervention and control groups in change in MRI outcomes (FreeSurfer 5.3) and (2) post hoc sub-group analyses of intervention effects on cognition in participants with more versus less pronounced structural brain changes at baseline (mixed-effects regression models, Stata 12).ResultsNo significant differences between the intervention and control groups were found on the changes in MRI measures. Beneficial intervention effects on processing speed were more pronounced in individuals with higher baseline cortical thickness in Alzheimer's disease signature areas (composite measure of entorhinal, inferior and middle temporal, and fusiform regions). The randomization group × time × cortical thickness interaction coefficient was 0.198 (p = 0.021). A similar trend was observed for higher hippocampal volume (group × time × hippocampus volume interaction coefficient 0.1149, p = 0.085).ConclusionsThe FINGER MRI exploratory sub-study did not show significant differences between the intervention and control groups on changes in regional brain volumes, regional cortical thicknesses, or WML volume after 2 years in at-risk elderly without substantial impairment. The cognitive benefits on processing speed of the FINGER intervention may be more pronounced in individuals with fewer structural brain changes on MRI at baseline. This suggests that preventive strategies may be more effective if started early, before the occurrence of more pronounced structural brain changes.Trial registrationClinicalTrials.gov, NCT01041989 . Registered January 5, 2010.

Project description:ObjectivesOur aim was to examine the impacts of baseline fatigue on the effectiveness of a physical activity (PA) intervention to prevent major mobility disability (MMD) and persistent major mobility disability (PMMD) in participants from the Lifestyle Interventions and Independence for Elders (LIFE) study.DesignProspective cohort of individuals aged 65 years or older undergoing structured PA intervention or health education (HE) for a mean of 2.6 years.SettingLIFE was a multicenter eight-site randomized trial that compared the efficacy of a structured PA intervention with an HE program in reducing the incidence of MMD.ParticipantsStudy participants (N = 1591) at baseline were 78.9 ± 5.2 years of age, with low PA and at risk for mobility impairment.MeasurementsSelf-reported fatigue was assessed using the modified trait version of the Exercise-Induced Feelings Inventory, a six-question scale rating energy levels in the past week. Responses ranged from 0 (none of the time) to 5 (all of the time). Total score was calculated by averaging across questions; baseline fatigue was based on the median split: 2 or higher = more fatigue (N = 856) and lower than 2 = less fatigue (N = 735). Participants performed a usual-paced 400-m walk every 6 months. We defined incident MMD as the inability to walk 400-m at follow-up visits; PMMD was defined as two consecutive walk failures. Cox proportional hazard models quantified the risk of MMD and PMMD in PA vs HE stratified by baseline fatigue adjusted for covariates.ResultsAmong those with higher baseline fatigue, PA participants had a 29% and 40% lower risk of MMD and PMMD, respectively, over the trial compared with HE (hazard ratio [HR] for MMD = .71; 95% confidence interval [CI] = .57-.90; P = .004) and PMMD (HR = .60; 95% CI = .44-.82; P = .001). For those with lower baseline fatigue, no group differences in MMD (P = .36) or PMMD (P = .82) were found. Results of baseline fatigue by intervention interaction was MMD (P = .18) and PMMD (P = .05).ConclusionA long-term moderate intensity PA intervention was particularly effective at preserving mobility in older adults with higher levels of baseline fatigue. J Am Geriatr Soc 68:619-624, 2020.

Project description:BackgroundA growing body of evidence supports the use of lifestyle interventions for preventing or delaying the onset of Alzheimer disease and other forms of dementia in at-risk individuals. The development of internet-delivered programs would increase the scalability and reach of these interventions, but requires validation to ensure similar effectiveness to brick-and-mortar options.ObjectiveWe describe the study design, recruitment process, and baseline participant characteristics of the sample in the Virtual Cognitive Health (VC Health) study. Future analyses will assess the impact of the remotely delivered lifestyle intervention on (1) cognitive function, (2) depression and anxiety, and (3) various lifestyle behaviors, including diet, exercise, and sleep, in a cohort of older adults with subjective memory decline. Additional analyses will explore feasibility outcomes, as well as the participants' engagement patterns with the program.MethodsOlder adults (aged 60-75 years) with subjective memory decline as measured by the Subjective Cognitive Decline 9-item (SCD-9) questionnaire, and who reported feeling worried about their memory decline, were eligible to participate in this single-arm pre-post study. All participants enrolled in the yearlong digital intervention, which consists of health coach-guided lifestyle change for improving diet, exercise, sleep, stress, and cognition. All components of this study were conducted remotely, including the collection of data and the administration of the intervention. We assessed participants at baseline, 12 weeks, 24 weeks, and 52 weeks with online surveys and the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) test. We will conduct intention-to-treat analysis on all outcomes.ResultsA total of 85 participants enrolled in the intervention and 82 are included in the study sample (3 participants withdrew). The study cohort of 82 participants comprises 61 (74%) female, 72 (88%) white, and 64 (78%) overweight or obese participants, and 55 (67%) have at least a college degree. The average baseline RBANS score was 95.9 (SD 11.1), which is within age-adjusted norms. The average SCD-9 score was 6.0 (SD 2.0), indicating minor subjective cognitive impairment at the beginning of the study. The average baseline Generalized Anxiety Disorder 7-item scale score was 6.2 (SD 4.5), and the average Patient Health Questionnaire 9-item score was 8.5 (SD 4.9), indicating mild levels of anxiety and depression at baseline.ConclusionsInternet-delivered lifestyle interventions are a scalable solution for the prevention or delay of Alzheimer disease. The results of this study will provide the first evidence for the effectiveness of a fully remote intervention and lay the groundwork for future investigations.Trial registrationClinicalTrials.gov NCT02969460; http://clinicaltrials.gov/ct2/show/NCT02969460 (Archived by WebCite at http://www.webcitation.org/71LkYAkSh).Registered report identifierRR1-10.2196/11368.

Project description:BackgroundGOIZ ZAINDU ("caring early" in Basque) is a pilot study to adapt the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) methodology to the Basque population and evaluate the feasibility and adherence to a FINGER-like multidomain intervention program. Additional aims included the assessment of efficacy on cognition and data collection to design a large efficacy trial.MethodGOIZ ZAINDU is a 1-year, randomized, controlled trial of a multidomain intervention in persons aged 60+ years, with Cardiovascular Risk Factors, Aging and Dementia (CAIDE) risk score ≥ 6, no diagnosis of dementia, and below-than-expected performance in at least one of three cognitive screening tests. Randomization to a multidomain intervention (MD-Int) or regular health advice (RHA) was stratified by sex, age (>/≤ 75), and cognitive status (mild cognitive impairment (MCI)/normal cognition). MD-Int included cardiovascular risk factor control, nutritional counseling, physical activity, and cognitive training. The primary outcomes were retention rate and adherence to the intervention program. Exploratory cognitive outcomes included changes in the Neuropsychological Test Battery z-scores. Analyses were performed according to the intention to treat.ResultsOne hundred twenty-five participants were recruited (mean age: 75.64 (± 6.46); 58% women). The MD-Int (n = 61) and RHA (n = 64) groups were balanced in terms of their demographics and cognition. Fifty-two (85%) participants from the RHA group and 56 (88%) from the MD-Int group completed the study. More than 70% of the participants had high overall adherence to the intervention activities. The risk of cognitive decline was higher in the RHA group than in the MD-Int group in terms of executive function (p =.019) and processing speed scores (p =.026).ConclusionsThe GOIZ-ZAINDU study proved that the FINGER methodology is adaptable and feasible in a different socio-cultural environment. The exploratory efficacy results showed a lower risk of decline in executive function and processing speed in the intervention group. These results support the design of a large-scale efficacy trial.Trial registrationGOIZ ZAINDU feasibility trial was approved and registered by the Euskadi Drug Research Ethics Committee (ID: PI2017134) on 23 January 2018. Retrospectively registered in ClinicalTrials.gov (NCT06163716) on 8 December 2023.

Dataset Information

Recruitment and baseline characteristics of participants in the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER)-a randomized controlled lifestyle trial.

Publications

Recruitment and baseline characteristics of participants in the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER)-a randomized controlled lifestyle trial.

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