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Trial record 1 of 1 for:    NCT01041989
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Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER)

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ClinicalTrials.gov Identifier: NCT01041989
Recruitment Status : Unknown
Verified October 2016 by Miia Kivipelto, Finnish Institute for Health and Welfare.
Recruitment status was:  Active, not recruiting
First Posted : January 5, 2010
Last Update Posted : October 10, 2016
Sponsor:
Collaborators:
Academy of Finland
University of Helsinki
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, Finnish Institute for Health and Welfare

Tracking Information
First Submitted Date  ICMJE January 4, 2010
First Posted Date  ICMJE January 5, 2010
Last Update Posted Date October 10, 2016
Study Start Date  ICMJE September 2009
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2010)
Cognitive impairment assessed with a Neuropsychological Test Battery, and Stroop and Trail Making tests. [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2010)
  • Depressive symptoms will be assessed using the Zung depression scale. [ Time Frame: 2 years ]
  • Disability will be assessed using the ADCS-ADL scale [ Time Frame: 2 years ]
  • Quality of Life will be assessed using the RAND-36 and 15D questionnaires. [ Time Frame: 2 years ]
  • Utilization of health resources will be assessed using questionnaire and register data. [ Time Frame: 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 ]
  • Vascular and metabolic morbidity and mortality will be assessed through questionnaire and register data. [ Time Frame: 2 years ]
  • Changes in dietary biomarker levels will be assessed through laboratory testing. [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability
Official Title  ICMJE Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability
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 7-year extended follow-up.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Cognitive Impairment
  • Dementia
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Behavioral: Nutritional guidance
    • Behavioral: Exercise
    • Behavioral: Cognitive training
    • Other: Reduction of vascular risk factors
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 4, 2010)
1200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 77 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01041989
Other Study ID Numbers  ICMJE THL/TUET 122/2009
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Miia Kivipelto, Finnish Institute for Health and Welfare
Study Sponsor  ICMJE Finnish Institute for Health and Welfare
Collaborators  ICMJE
  • Academy of Finland
  • University of Helsinki
  • University of Eastern Finland
  • University of Oulu
  • Kuopio Research Institute of Exercise Medicine
  • University of Western Ontario, Canada
  • Karolinska Institutet
  • Umeå University
Investigators  ICMJE
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: Markku Peltonen, Adjunct prof Finnish Institute for Health and Welfare
Study Director: Satu Pajala, PhD Finnish Institute for Health and Welfare
Study Director: Jaana Lindström, Adjunct prof. Finnish Institute for Health and Welfare
Study Director: Riitta Antikainen, Adjunct prof Oulu City Health Services
Study Director: Tiia Ngandu, MD, PhD Finnish Institute for Health and Welfare
Study Director: Tuomo Hänninen, Adjunct prof University of Eastern Finland
PRS Account Finnish Institute for Health and Welfare
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP