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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Academy of Finland
Helsinki University
University of Eastern Finland
University of Oulu
Kuopio Research Institute of Exercise Medicine
University of Western Ontario, Canada
Karolinska Institutet
Umeå University
Information provided by (Responsible Party):
Miia Kivipelto, National Institute for Health and Welfare, Finland
ClinicalTrials.gov Identifier:
NCT01041989
First received: January 4, 2010
Last updated: August 6, 2012
Last verified: August 2012
History of Changes
  Purpose

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 7-year extended follow-up.


Condition Intervention
Cognitive Impairment
Dementia
 Behavioral: Nutritional guidance
Behavioral: Exercise
Behavioral: Cognitive training
Other: Reduction of vascular risk factors

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute for Health and Welfare, Finland:

Primary Outcome Measures:
  • Cognitive impairment assessed with a Neuropsychological Test Battery, and Stroop and Trail Making tests. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Depressive symptoms will be assessed using the Zung depression scale. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Disability will be assessed using the ADCS-ADL scale [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Quality of Life will be assessed using the RAND-36 and 15D questionnaires. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Utilization of health resources will be assessed using questionnaire and register data. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Vascular and metabolic risk factors will be assessed with blood pressure and anthropometric measurements, and laboratory analyses of metabolic biomarkers. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Vascular and metabolic morbidity and mortality will be assessed through questionnaire and register data. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Changes in dietary biomarker levels will be assessed through laboratory testing. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1200
Study Start Date: September 2009
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   60 Years to 77 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01041989

Locations
Finland
National Institute for Health and Welfare
Helsinki, Finland, 00300
University of Kuopio
Kuopio, Finland, 70211
University of Oulu
Oulu, Finland, 90014
Research Center Mediwest
Seinajoki, Finland, 60220
National Institute for Health and Welfare
Turku, Finland, 20720
Sponsors and Collaborators
National Institute for Health and Welfare, Finland
Academy of Finland
Helsinki University
University of Eastern Finland
University of Oulu
Kuopio Research Institute of Exercise Medicine
University of Western Ontario, Canada
Karolinska Institutet
Umeå University
Investigators
Principal Investigator: Miia Kivipelto, professor National Institute for Health and Welfare, Finland
Study Director: Tiina K Laatikainen, professor National Institute for Health and Welfare, Finland
Study Director: Hilkka S Soininen, professor University of Eastern Finland
Study Director: Jaakko Tuomilehto, professor Helsinki University
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 National Institute for Health and Welfare, Finland
Study Director: Markku Peltonen, Adjunct prof National Institute for Health and Welfare, Finland
Study Director: Satu Pajala, PhD National Institute for Health and Welfare, Finland
Study Director: Jaana Lindström, Adjunct prof. National Institute for Health and Welfare, Finland
Study Director: Riitta Antikainen, Adjunct prof Oulu City Health Services
Study Director: Satu Ahtiluoto, MD National Institute for Health and Welfare, Finland
Study Director: Tiia Ngandu, MD, PhD National Institute for Health and Welfare, Finland
Study Director: Tuomo Hänninen, Adjunct prof University of Eastern Finland
  More Information

Publications:

Responsible Party: Miia Kivipelto, Professor, National Institute for Health and Welfare, Finland
ClinicalTrials.gov Identifier: NCT01041989     History of Changes
Other Study ID Numbers: THL/TUET 122/2009
Study First Received: January 4, 2010
Last Updated: August 6, 2012
Health Authority: Finland: Ethics Committee

Keywords provided by National Institute for Health and Welfare, Finland:
dementia
cognitive impairment
disability
 intervention
elderly
lifestyle counseling

Additional relevant MeSH terms:
Dementia
Cognition Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013