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

NCT07117916 | Not Yet Recruiting

• 1 other identifier: 2023-01125
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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

Keywords

Dementia prevention; Primary care; Clinical effectiveness; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Composite healthy lifestyle score

  The primary outcome is a composite healthy lifestyle score based on four domains measured individually: dietary intake (Mediterranean Diet Adherence Screener ), physical activity (ActiGraph), cognitive and social engagement (combined self-reported), and cardiovascular risk burden (BMI, lipids, glucose, waist-to-hip ratio, and smoking status).

  Assessments are conducted at baseline, 6 months (primary endpoint), and 12 months post-randomization

Secondary Outcomes (1)

• Changes in functioning and symptoms

  Baseline, 6- and 12 months post randomization

Other Outcomes (2)

• Delivery of the intervention

  Data will be collected throughout the intervention period of six months.

• Stakeholder perspectives

  During, and after the delivery of the intervention.

Study Arms (2)

Supervised multidomain intervention

EXPERIMENTAL

The structured multidomain lifestyle intervention (intervention group)

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

Self-guided intervention

ACTIVE COMPARATOR

The self-guided intervention (control group)

Behavioral: Self-Guided

Interventions

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

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

Supervised multidomain intervention

Self-Guided BEHAVIORAL

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.

Self-guided intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Karolinska Institutet: lead
• Stiftelsen Stockholms Sjukhem: collaborator

MeSH Terms

Interventions

Exercise; Cognitive Training

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Miia Kivipelto, PhD, Professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrik Karlsson, PhD

CONTACT

+46739655642; patrik.karlsson@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 12, 2025
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share