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

Primary Purpose

Cognitive Impairment, Dementia

Status
Active
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Nutritional guidance
Exercise
Cognitive training
Reduction of vascular risk factors
Sponsored by
Finnish Institute for Health and Welfare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cognitive Impairment focused on measuring dementia, cognitive impairment, disability, intervention, elderly, lifestyle counseling

Eligibility Criteria

60 Years - 77 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Finnish Institute for Health and Welfare
  • University of Eastern Finland
  • University of Oulu
  • Research Center Mediwest
  • Finnish Institute for Health and Welfare

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard health counseling at baseline

Lifestyle counseling

Arm Description

Multi-domain lifestyle counseling including nutritional guidance, increased physical activity, cognitive training, increased social activity and intensive monitoring of vascular and metabolic risk factors.

Outcomes

Primary Outcome Measures

Cognitive impairment assessed with a Neuropsychological Test Battery, and Stroop and Trail Making tests.

Secondary Outcome Measures

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

Full Information

First Posted
January 4, 2010
Last Updated
April 17, 2023
Sponsor
Finnish Institute for Health and Welfare
Collaborators
Academy of Finland, University of Helsinki, University of Eastern Finland, University of Oulu, Kuopio Research Institute of Exercise Medicine, Western University, Canada, Karolinska Institutet, Umeå University
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1. Study Identification

Unique Protocol Identification Number
NCT01041989
Brief Title
Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability
Acronym
FINGER
Official Title
Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Finnish Institute for Health and Welfare
Collaborators
Academy of Finland, University of Helsinki, University of Eastern Finland, University of Oulu, Kuopio Research Institute of Exercise Medicine, Western University, Canada, Karolinska Institutet, Umeå University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment, Dementia
Keywords
dementia, cognitive impairment, disability, intervention, elderly, lifestyle counseling

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard health counseling at baseline
Arm Type
No Intervention
Arm Title
Lifestyle counseling
Arm Type
Experimental
Arm Description
Multi-domain lifestyle counseling including nutritional guidance, increased physical activity, cognitive training, increased social activity and intensive monitoring of vascular and metabolic risk factors.
Intervention Type
Behavioral
Intervention Name(s)
Nutritional guidance
Intervention Description
Individual counseling sessions and group meetings will be organized.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Guided muscle strength training and aerobic exercise.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Reduction of vascular risk factors
Intervention Description
Monitoring and maintenance of metabolic and vascular risk factors
Primary Outcome Measure Information:
Title
Cognitive impairment assessed with a Neuropsychological Test Battery, and Stroop and Trail Making tests.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Depressive symptoms will be assessed using the Zung depression scale.
Time Frame
2 years
Title
Disability will be assessed using the ADCS-ADL scale
Time Frame
2 years
Title
Quality of Life will be assessed using the RAND-36 and 15D questionnaires.
Time Frame
2 years
Title
Utilization of health resources will be assessed using questionnaire and register data.
Time Frame
2 years
Title
Vascular and metabolic risk factors will be assessed with blood pressure and anthropometric measurements, and laboratory analyses of metabolic biomarkers.
Time Frame
2 years
Title
Vascular and metabolic morbidity and mortality will be assessed through questionnaire and register data.
Time Frame
2 years
Title
Changes in dietary biomarker levels will be assessed through laboratory testing.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
77 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miia Kivipelto, professor
Organizational Affiliation
Finnish Institute for Health and Welfare
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tiina K Laatikainen, professor
Organizational Affiliation
Finnish Institute for Health and Welfare
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hilkka S Soininen, professor
Organizational Affiliation
University of Eastern Finland
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jaakko Tuomilehto, professor
Organizational Affiliation
University of Helsinki
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Timo E Strandberg, professor
Organizational Affiliation
University of Oulu
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Raimo Sulkava, professor
Organizational Affiliation
University of Eastern Finland
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rainer Rauramaa, professor
Organizational Affiliation
Kuopio Research Institute of Exercise Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Antti Jula, research prof
Organizational Affiliation
Finnish Institute for Health and Welfare
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Markku Peltonen, research professor
Organizational Affiliation
Finnish Institute for Health and Welfare
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Satu Havulinna, PhD
Organizational Affiliation
Finnish Institute for Health and Welfare
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jaana Lindström, Adjunct prof.
Organizational Affiliation
Finnish Institute for Health and Welfare
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Riitta Antikainen, professor
Organizational Affiliation
Oulu City Health Services
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tiia Ngandu, MD, PhD, Adjunct professor
Organizational Affiliation
Finnish Institute for Health and Welfare
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tuomo Hänninen, Adjunct prof
Organizational Affiliation
University of Eastern Finland
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jenni Lehtisalo, PhD
Organizational Affiliation
Finnish Institute for Health and Welfare
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alina Solomon, MD, PhD, Adjunct professor
Organizational Affiliation
University of Eastern Finland
Official's Role
Study Director
Facility Information:
Facility Name
Finnish Institute for Health and Welfare
City
Helsinki
ZIP/Postal Code
00300
Country
Finland
Facility Name
University of Eastern Finland
City
Kuopio
ZIP/Postal Code
70211
Country
Finland
Facility Name
University of Oulu
City
Oulu
ZIP/Postal Code
90014
Country
Finland
Facility Name
Research Center Mediwest
City
Seinajoki
ZIP/Postal Code
60220
Country
Finland
Facility Name
Finnish Institute for Health and Welfare
City
Turku
ZIP/Postal Code
20720
Country
Finland

12. IPD Sharing Statement

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Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability

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