Older Adults at High Risk for MCISTRONGERNCT07117916
STRONGER 60+: Assessing the Clinical Effectiveness and Delivery of an Adapted FINGER Model for Brain Health in Primary Care
A study testing Supervised nutritional guidance, physical exercise, cognitive training, social engagement, and management of vascular and metabolic risk factors. and Self-Guided in people with Older Adults at High Risk for MCI and Older Adults With Mild to Moderate Level of Dementia, run by Karolinska Institutet.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Older Adults at High Risk for MCI, Older Adults With Mild to Moderate Level of Dementia
- What is being tested?
- Supervised nutritional guidance, physical exercise, cognitive training, social engagement, and management of vascular and metabolic risk factors. and Self-Guided
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to Aug 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Exclusion criteria include diagnosed dementia and residence in a nursing home.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.
- Being tested
- Supervised nutritional guidance, physical exercise, cognitive training, social engagement, and management of vascular and metabolic risk factors., Self-Guided
- Keywords
- Dementia prevention, Primary care, Clinical effectiveness, Randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised nutritional guidance, physical exercise, cognitive training, social engagement, and management of vascular and metabolic risk factors.Behavioural
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-GuidedBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Supervised multidomain intervention | Experimental | The structured multidomain lifestyle intervention (intervention group) Receives: 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) Receives: Behavioral: Self-Guided |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Assessments are conducted at baseline, 6 months (primary endpoint), and 12 months post-randomization
Secondary outcomes (1)
Changes in functioning and symptoms
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).
Measured: Baseline, 6- and 12 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start1 Aug 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Older Adults at High Risk for MCIStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Stiftelsen Stockholms Sjukhem
- Responsible party
- Principal investigator, Miia Kivipelto, Karolinska Institutet
- Investigators
- Miia Kivipelto, PhD, Professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07117916
- Sponsor's protocol ID
- 2023-01125
- Other IDs
- 2023
- Acronym
- STRONGER
- Status last verified
- Mar 2026
- First submitted
- 11 Aug 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data to be collected will be available upon request. Requests for access can be directed to the Research Data Office (rdo@ki.se) at Karolinska Institutet, where they will be processed in accordance with relevant legislation. Access will require a data processing agreement or equivalent with the data recipient. This procedure complies with the General Data Protection Regulation, reflecting the high sensitivity of the data and the potential harm to individuals if made publicly available.
Publications
Welmer AK, Leavy B, Thunborg C, Holleman J, Karlsson P, Hallinder H, Aspo M, Bergstrom C, Akesson E, Kulmala J, Kivipelto M. STRONGER 60+: study protocol for a mixed-methods randomised controlled trial assessing the clinical effectiveness and delivery of an adapted FINGER model for brain health in primary care. BMJ Open. 2026 Apr 13;16(4):e111346. doi: 10.1136/bmjopen-2025-111346.
PubMed 41974549