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NCT Number: NCT07117916

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

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.

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Key information

Conditions

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

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

include diagnosed dementia and residence in a nursing home.

Treatment and study plan

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

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.

Primary outcomes

Composite healthy lifestyle score

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

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).

Secondary outcomes

Changes in functioning and symptoms

Time frame: Baseline, 6- and 12 months post randomization

Physical function by Short Physical Performance battery (SPPB) total score 0-12, where higher scores indicate better physical function. Cognitive function by Mini Mental State Examination (MMSE) total score ranges from 0-30, where higher scores indicate better cognitive function. Geriatric Depression Scale (GDS15) total score ranges from 0-15, where higher scores indicate more depressive symptoms, Health Related Quality of Life (RAND-36) each domain score ranges from 0-100, where higher scores indicate better health-related quality of life. Pittsburg Sleep Quality Index (PSQI) total score ranges from 0-21, where higher scores indicate worse sleep quality. A 10-meter walking test (m/s where higher speed is associated with greater functioning).

Other outcomes

Delivery of the intervention

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

The intervention will be assessed through analysis of recruitment, retention, and adherence rates among participants in the intervention group. Recruitment rate is defined as the proportion of eligible individuals who consent to participate after being invited, with ≥50% considered successful. Retention rate refers to the proportion completing the 6-month intervention, with a dropout rate below 35% indicating acceptable retention. Reasons for dropout and occurrence of any adverse events will be recorded as reported by participants. Overall adherence will be calculated as the proportion of attended sessions relative to the total number offered. Adherence will also be assessed within each domain of the intervention (Nutritional guidance, Physical exercise, Cognitive training, Vascular and metabolic risk management).
Stakeholder perspectives

Time frame: During, and after the delivery of the intervention.

Qualitative data from in-depth interviews with individuals participating in the study, and focus groups with healthcare professionals involved with delivering the intervention.

Study contacts

Contact information is provided by the study sponsor or research team.

Patrik Karlsson, PhD

CONTACT

[email protected]

+46739655642

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

Stiftelsen Stockholms Sjukhem

Registry information

Official study title

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

Acronym: STRONGER

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Aug 12, 2025
Registry last updated: Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.