Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER)

April 17, 2023 updated by: Miia Kivipelto, Finnish Institute for Health and Welfare
This multi-center (6 sites: Helsinki, Kuopio, Oulu, Seinäjoki, Turku, Vantaa) intervention study aims to prevent cognitive impairment, dementia and disability in 60-77 year old persons at an increased dementia risk. The 2-year multi-domain life-style intervention includes nutritional guidance, exercise, cognitive training, increased social activity, and intensive monitoring and management of metabolic and vascular risk factors. The primary outcome is cognitive impairment measured by a sensitive Neuropsychological Test Battery (NTB), and Stroop and Trail Making tests to capture early cognitive impairment typical for both Alzheimer's disease and vascular dementia. We hypothesize that the multi-domain intervention will reduce cognitive impairment in the study group compared to the control group during the initial 2-year intervention period and reduce dementia incidence after the extended follow-up (until at least 300 participants have developed dementia).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00300
        • Finnish Institute for Health and Welfare
      • Kuopio, Finland, 70211
        • University of Eastern Finland
      • Oulu, Finland, 90014
        • University of Oulu
      • Seinajoki, Finland, 60220
        • Research Center Mediwest
      • Turku, Finland, 20720
        • Finnish Institute for Health and Welfare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 77 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • aged 60-77 years
  • dementia Risk Score 6 points or more
  • fulfillment of at least one of the following CERAD criteria: i) MMSE: 20-26 points ii) word list memory task (3x10 words): 19 words or less iii) delayed recall: 75% or less

Exclusion Criteria:

  • malignant diseases
  • dementia
  • substantial cognitive decline
  • major depression
  • symptomatic cardiovascular disease
  • revascularisation within 1 year
  • severe loss of vision, hearing or communicative ability
  • other conditions inhibiting from safe engagement in the prescribed intervention as judged by the study physician
  • other conditions preventing from cooperation as judged by the study physician

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard health counseling at baseline
Experimental: Lifestyle counseling
Multi-domain lifestyle counseling including nutritional guidance, increased physical activity, cognitive training, increased social activity and intensive monitoring of vascular and metabolic risk factors.
Behavioral: Nutritional guidance
Individual counseling sessions and group meetings will be organized.
Behavioral: Exercise
Guided muscle strength training and aerobic exercise.
Behavioral: Cognitive training
Cognitive training will be implemented through 8 group sessions lead by a psychologist and a computer-based cognitive training program available to participants via the internet.
Other: Reduction of vascular risk factors
Monitoring and maintenance of metabolic and vascular risk factors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cognitive impairment assessed with a Neuropsychological Test Battery, and Stroop and Trail Making tests.
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Depressive symptoms will be assessed using the Zung depression scale.
Time Frame: 2 years
2 years
Disability will be assessed using the ADCS-ADL scale
Time Frame: 2 years
2 years
Quality of Life will be assessed using the RAND-36 and 15D questionnaires.
Time Frame: 2 years
2 years
Utilization of health resources will be assessed using questionnaire and register data.
Time Frame: 2 years
2 years
Vascular and metabolic risk factors will be assessed with blood pressure and anthropometric measurements, and laboratory analyses of metabolic biomarkers.
Time Frame: 2 years
2 years
Vascular and metabolic morbidity and mortality will be assessed through questionnaire and register data.
Time Frame: 2 years
2 years
Changes in dietary biomarker levels will be assessed through laboratory testing.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Finnish Institute for Health and Welfare

Collaborators

Karolinska Institutet
Umeå University
Western University, Canada
University of Helsinki
University of Eastern Finland
University of Oulu
Academy of Finland
Kuopio Research Institute of Exercise Medicine

Investigators

  • Principal Investigator: Miia Kivipelto, professor, Finnish Institute for Health and Welfare
  • Study Director: Tiina K Laatikainen, professor, Finnish Institute for Health and Welfare
  • Study Director: Hilkka S Soininen, professor, University of Eastern Finland
  • Study Director: Jaakko Tuomilehto, professor, University of Helsinki
  • Study Director: Timo E Strandberg, professor, University of Oulu
  • Study Director: Raimo Sulkava, professor, University of Eastern Finland
  • Study Director: Rainer Rauramaa, professor, Kuopio Research Institute of Exercise Medicine
  • Study Director: Antti Jula, research prof, Finnish Institute for Health and Welfare
  • Study Director: Jaana Lindström, Adjunct prof., Finnish Institute for Health and Welfare
  • Study Director: Tuomo Hänninen, Adjunct prof, University of Eastern Finland
  • Study Director: Markku Peltonen, research professor, Finnish Institute for Health and Welfare
  • Study Director: Satu Havulinna, PhD, Finnish Institute for Health and Welfare
  • Study Director: Riitta Antikainen, professor, Oulu City Health Services
  • Study Director: Tiia Ngandu, MD, PhD, Adjunct professor, Finnish Institute for Health and Welfare
  • Study Director: Jenni Lehtisalo, PhD, Finnish Institute for Health and Welfare
  • Study Director: Alina Solomon, MD, PhD, Adjunct professor, University of Eastern Finland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

December 1, 2013

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

January 4, 2010

First Submitted That Met QC Criteria

January 4, 2010

First Posted (Estimate)

January 5, 2010

Study Record Updates

Last Update Posted (Actual)

April 19, 2023

Last Update Submitted That Met QC Criteria

April 17, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THL/TUET 122/2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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