NCT07117916

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

STRONGER 60+: Study Protocol for a Mixed-methods Randomized Controlled Trial Assessing the Clinical Effectiveness and Delivery of an Adapted FINGER Model for Brain Health in Primary Care

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	Supervised nutritional guidance, physical exercise, cognitive training, social engagement, and management of vascular and metabolic risk factors.	The structured multidomain lifestyle intervention (intervention group) In addition to health advice, participants in the intervention group will receive a structured, multimodal lifestyle program comprising nutritional guidance, physical exercise, cognitive training and social engagement, and monitoring and management of vascular and metabolic risk factors. The nutritional component consists of one group session and two individual counseling sessions with the study dietician. The physical exercise component is based on international guidelines and adapted from the FINGER exercise program. Cognitive training involves both a group session and individual, home-based sessions. Social interaction is actively encouraged throughout the program, particularly during gym and group activities. Monitoring and management of vascular and metabolic risk factors follows established evidence-based guidelines, and includes a follow-up appointment with clinical staff at three months
BEHAVIORAL	Self-Guided	The self-guided intervention (control group) Participants in the control group will receive a self-guided version of the intervention. All participants, regardless of group allocation, will meet with the study nurse at screening, baseline, and six months post-randomization for health assessments. These assessments will include blood sampling, blood pressure, weight, body mass index (BMI), and hip and waist circumference. A medical history and physical examination will be performed by the study nurse or physician. At the baseline visit, all participants will receive both verbal and written guidance from the study nurse on maintaining a healthy diet, staying physically, cognitively, and socially active, and managing vascular risk factors. This information, aligned with national and international guidelines (e.g., on nutrition and physical activity), mirrors the content provided to the intervention group and is intended to support vascular risk reduction and promote healthy aging.

Timeline

• Start date: 2026-08-01
• Primary completion: 2028-02-01
• Completion: 2028-08-01
• First posted: 2025-08-12
• Last updated: 2026-03-27