The FINGER Model - Preventing Cognitive Decline and Promoting Health of Older People.

NCT07661472 | Not Yet Recruiting

• 1 other identifier: HIG-FORSK 2026/35
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Cognitive impairment and dementia can cause considerable suffering, both for the person affected and for next of kin. They also pose major challenges for health and social care. At the same time, research shows that many risk factors for cognitive decline can, in fact, be influenced. This is particularly the case when several areas are addressed simultaneously, such as physical activity, healthy eating habits, mental stimulation, social connectedness, and good cardiovascular health. A well-known model for such a multidomain preventive intervention is the FINGER model: the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability. In the randomized controlled FINGER study, the results showed that a two-year programme comprising diet, exercise, cognitive training, social activity, and structured monitoring of vascular risk factors could improve and maintain cognitive function among older people at increased risk of cognitive decline. However, the research evidence is not unequivocal. Other randomized studies found no effect on cognitive outcomes over three years in the studied population, and in a cluster-randomized study reported no clear effects on the incidence of dementia in the older population. In addition, studies are needed that follow changes when the model is implemented in clinical practice. In recent years, the FINGER model has also been adapted and tested in several countries through the FINGER network, with the aim of developing and evaluating interventions that work in different contexts, while also strengthening knowledge and enabling comparisons of results between countries. A recently published qualitative study showed that participants were often motivated by an expectation of personal benefit, both for brain health and physical health, but also by concerns about cognitive decline. Social aspects also played an important role, as did the need for the interventions to feel understandable and for lifestyle changes to be perceived as realistic and feasible in everyday life. The overall aim of the project is to evaluate a municipality-initiated, health-promoting multicomponent programme, based on the FINGER model, for older people, with a focus on health, health-related quality of life, well-being, and lifestyle habits (group A), and to compare it with a programme with fewer components (group B) implemented in the municipality. Furthermore, the aim is to explore older people's experiences of participating in the project, as well as how older people in the study rate their health and well-being before, during, and after completing their participation in the project. The main research questions are:

• How do older people rate their health, health-related quality of life, well-being, and lifestyle habits before, during, and after participation in the municipality's project (groups A and B)?
• What cognitive and physical functional ability do older people have before, during, and after participation in the municipality's project (group A)?
• Are there any differences over time within each group (A and B), and are there any differences over time between the groups in the project?
• Do self-rated health and health-related quality of life in this study population differ from the values reported in a previously published study?
• How do older people experience participating in the project (group A)?

Conditions

Older People

Keywords

Physical activity; Health; health-related quality of life; well-being; lifestyle habits; cognitive and physical functional ability

Outcome Measures

Primary Outcomes (1)

• Older peoples' rating of their health, well-being, and functional ability in everyday life.

  Survey, RAND-36 with 8 dimensions: Physical Function, Role Physical, Role mental, Vitality, Mental Health, Social Function, Bodily Pain, and General Health with scores 0-100, higher scores a more desirable outcome for wellbeing.

  [Time Frame: Data collection at baseline (T(time)0, before)) intervention, follow-up (T1, end of intervention), 3 months after T0 (T2) and 6 months after T0 (T3).]

Secondary Outcomes (3)

• Older peoples' rating of their health/wellbeing

  [Time Frame: Data collection at baseline (T(time)0, before)) intervention, follow-up (T1, end of intervention), 3 months after T0 (T2) and 6 months after T0 (T3).]

• Older peoples' rating of their health/wellbeing - Loneliness

  [Time Frame: Data collection at baseline (T(time)0, before)) intervention, follow-up (T1, end of intervention), 3 months after T0 (T2) and 6 months after T0 (T3).]

• Older peoples' rating of their health/wellbeing - Depression and anxiety

  [Time Frame: Data collection at baseline (T(time)0, before)) intervention, follow-up (T1, end of intervention), 3 months after T0 (T2) and 6 months after T0 (T3).]

Other Outcomes (1)

• Older peoples' rating of their cognitive function

  [Time Frame: Data collection at baseline (T(time)0, before)) intervention and 6 months after T0 (T3).]

Study Arms (2)

The Brain Group

EXPERIMENTAL

The FINGER model, based on a combination of education, physical exercise, dietary interventions, cognitive training, social components, and follow-up of cardiovascular-related factors: * Physical activity: one instructor-led group exercise session per week and one individual exercise session per week, a lecture on physical activity and brain health, and individual programme planning. * Cognitive training: home-based training three times per week for approximately 15 minutes, two practical workshops, and a lecture on cognitive training and brain health. * Diet: a lecture on diet and two practical workshops. * Social interaction: a social gathering in connection with the group exercise session, as well as support in finding associations and activities. * Cardiovascular health: blood sampling and health checks at the start and end of the programme, as well as a lecture on cardiovascular health, including oral health, hearing, and vision * Supportive counselling

Other: FINGER model

The Brain Fellowship

NO INTERVENTION

The Brain Fellowship (group B) will be offered participation in five lectures related to the five FINGER components (physical activity, cognitive training, diet, social interaction and supportive counselling).

Interventions

FINGER model OTHER

The FINGER model, based on a combination of education, physical exercise, dietary interventions, cognitive training, social components, and follow-up of cardiovascular-related factors: * Physical activity: one instructor-led group exercise session per week and one individual exercise session per week, a lecture on physical activity and brain health, and individual programme planning. * Cognitive training: home-based training three times per week for approximately 15 minutes, two practical workshops, and a lecture on cognitive training and brain health. * Diet: a lecture on diet and two practical workshops. * Social interaction: a social gathering in connection with the group exercise session, as well as support in finding associations and activities. * Cardiovascular health: blood sampling and health checks at the start and end of the programme, as well as a lecture on cardiovascular health, including oral health, hearing, and vision * Supportive counselling

The Brain Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• older person is 65 years or older, registered as a resident in Bollnäs Municipality, and responds to questions about lifestyle habits, well-being, memory, and cardiovascular diseases. Participants must also be able to take responsibility for their own transport to and from physical meetings, have access to their own digital device, such as a smartphone, computer, or iPad, and have the time and opportunity to attend weekly sessions over a period of nine months. For participation in the research study, participants must also be able to take part in an interview in Swedish, complete a questionnaire, and provide informed consent. For participants who are only included in the questionnaire-based part of the study, the criteria are the ability to complete a questionnaire and provide informed consent.

You may not qualify if:

• if the person has cognitive impairment or dementia to such an extent that an interview is not considered possible or ethically appropriate, has pronounced communication difficulties that make an interview impossible, and/or requires an interpreter.

Sponsors & Collaborators

• University of Gavle: lead

Study Sites (1)

University of Gävle

Gävle, Sweden

Location

Related Publications (5)

• Shulman KI. Clock-drawing: is it the ideal cognitive screening test? Int J Geriatr Psychiatry. 2000 Jun;15(6):548-61. doi: 10.1002/1099-1166(200006)15:63.0.co;2-u.

  PMID: 10861923 BACKGROUND

• Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT. A Short Scale for Measuring Loneliness in Large Surveys: Results From Two Population-Based Studies. Res Aging. 2004;26(6):655-672. doi: 10.1177/0164027504268574.

  PMID: 18504506 BACKGROUND

• Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.

  PMID: 21479777 BACKGROUND

• Hays RD, Sherbourne CD, Mazel RM. The RAND 36-Item Health Survey 1.0. Health Econ. 1993 Oct;2(3):217-27. doi: 10.1002/hec.4730020305.

  PMID: 8275167 BACKGROUND

• Graneheim UH, Lundman B. Qualitative content analysis in nursing research: concepts, procedures and measures to achieve trustworthiness. Nurse Educ Today. 2004 Feb;24(2):105-12. doi: 10.1016/j.nedt.2003.10.001.

  PMID: 14769454 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Annakarin Olsson, Associate professor, PhD

  University of Gävle

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annakarin Olsson, Associate professor, PhD

CONTACT

0046730552625; annakarin.olsson@hig.se

Maria Engström, Professor, PhD

CONTACT

004626648215; maria.engstrom@hig.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 22, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)