STRONGER 60+: Assessing the Clinical Effectiveness and Delivery of an Adapted FINGER Model for Brain Health in Primary Care

NCT ID: NCT07117916

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-08-01
• Study Completion Date: 2028-08-31

Brief Summary

Background: The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) was the first to show that multidomain lifestyle interventions can enhance brain health and reduce cognitive decline. However, the clinical effectiveness and delivery of the FINGER model within primary care settings remain unexplored. The aim of the STRONGER 60+ trial is to evaluate both the clinical effectiveness and real-world delivery of an adapted FINGER-based intervention in primary care.

Methods and analysis: This 6-month randomized controlled clinical effectiveness trial will be conducted in primary care and will include adults aged 60 and older with vascular or lifestyle-related risk factors for dementia. A total of 96 participants will be randomized to either a structured, supervised multidomain lifestyle intervention or a self-guided version of the same program. The intervention includes nutritional guidance, physical exercise, cognitive training, social engagement, and management of vascular and metabolic risk factors. Data will be collected at baseline, 6 months (primary endpoint), and 12 months post-randomization. The primary outcome is the change in a composite healthy lifestyle score at 6 months. In addition, the study will explore delivery processes and stakeholder (participant and healthcare professional) perspectives using both qualitative and quantitative methods.

Conditions

Older Adults at High Risk for MCI; Older Adults With Mild to Moderate Level of Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Supervised multidomain intervention

The supervised intervention includes nutritional guidance, physical exercise, cognitive training, social engagement, and management of vascular and metabolic risk factors.

Group Type: EXPERIMENTAL

Supervised nutritional guidance, physical exercise, cognitive training, social engagement, and management of vascular and metabolic risk factors.

Intervention Type: BEHAVIORAL

In addition to health advice, participants in the intervention group will receive a structured, multidomain lifestyle program comprising nutritional guidance, physical exercise, cognitive training and social engagement, and monitoring and management of vascular and metabolic risk factors. The STRONGER 60+ intervention is based on the FINGER protocol and has been specifically adapted for primary care to enhance feasibility and scalability. Key adaptations include 1) delivering physical exercise sessions at external gym facilities rather than at primary care centers, and 2) shortening the intervention duration from two years to six months.

Self-guided intervention

Self-guided version of the intervention.

Group Type: ACTIVE_COMPARATOR

Supervised nutritional guidance, physical exercise, cognitive training, social engagement, and management of vascular and metabolic risk factors.

Intervention Type: BEHAVIORAL

In addition to health advice, participants in the intervention group will receive a structured, multidomain lifestyle program comprising nutritional guidance, physical exercise, cognitive training and social engagement, and monitoring and management of vascular and metabolic risk factors. The STRONGER 60+ intervention is based on the FINGER protocol and has been specifically adapted for primary care to enhance feasibility and scalability. Key adaptations include 1) delivering physical exercise sessions at external gym facilities rather than at primary care centers, and 2) shortening the intervention duration from two years to six months.

Interventions

Supervised nutritional guidance, physical exercise, cognitive training, social engagement, and management of vascular and metabolic risk factors.

In addition to health advice, participants in the intervention group will receive a structured, multidomain lifestyle program comprising nutritional guidance, physical exercise, cognitive training and social engagement, and monitoring and management of vascular and metabolic risk factors. The STRONGER 60+ intervention is based on the FINGER protocol and has been specifically adapted for primary care to enhance feasibility and scalability. Key adaptations include 1) delivering physical exercise sessions at external gym facilities rather than at primary care centers, and 2) shortening the intervention duration from two years to six months.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria:

Individuals aged 60 and older who express interest in the study will be pre-screened by the research team using the CAIDE (Cardiovascular Risk Factors, Aging, and Dementia) Risk Score. Those scoring ≥6-indicating elevated dementia risk-will be invited for an in-person screening visit to confirm eligibility. The CAIDE score (range: 4-15) is based on age, sex, education, systolic blood pressure, BMI, total cholesterol, and physical activity. Additional inclusion criteria are a Mini-Mental State Examination (MMSE) score of ≥24, and ability to walk independently indoors and outdoors (with or without a mobility aid).

Exclusion Criteria:

Exclusion criteria include diagnosed dementia and residence in a nursing home.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stiftelsen Stockholms Sjukhem

OTHER

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Miia Kivipelto

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Miia Kivipelto, PhD, Professor

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Central Contacts

Patrik Karlsson, PhD

Role: CONTACT

patrik.karlsson@ki.se

+46739655642

Other Identifiers

2023-01125

Identifier Type: -

Identifier Source: org_study_id