Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability
NCT01041989 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1200
Last updated 2023-04-19
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).
Conditions
Interventions
- 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
Sponsors & Collaborators
-
Academy of Finland
collaborator OTHER -
University of Helsinki
collaborator OTHER -
University of Eastern Finland
collaborator OTHER -
University of Oulu
collaborator OTHER -
Kuopio Research Institute of Exercise Medicine
collaborator OTHER -
Western University, Canada
collaborator OTHER - collaborator OTHER
-
Umeå University
collaborator OTHER -
Finnish Institute for Health and Welfare
lead OTHER_GOV
Principal Investigators
-
Miia Kivipelto, professor · Finnish Institute for Health and Welfare
-
Tiina K Laatikainen, professor · Finnish Institute for Health and Welfare
-
Hilkka S Soininen, professor · University of Eastern Finland
-
Jaakko Tuomilehto, professor · University of Helsinki
-
Timo E Strandberg, professor · University of Oulu
-
Raimo Sulkava, professor · University of Eastern Finland
-
Rainer Rauramaa, professor · Kuopio Research Institute of Exercise Medicine
-
Antti Jula, research prof · Finnish Institute for Health and Welfare
-
Markku Peltonen, research professor · Finnish Institute for Health and Welfare
-
Satu Havulinna, PhD · Finnish Institute for Health and Welfare
-
Jaana Lindström, Adjunct prof. · Finnish Institute for Health and Welfare
-
Riitta Antikainen, professor · Oulu City Health Services
-
Tiia Ngandu, MD, PhD, Adjunct professor · Finnish Institute for Health and Welfare
-
Tuomo Hänninen, Adjunct prof · University of Eastern Finland
-
Jenni Lehtisalo, PhD · Finnish Institute for Health and Welfare
-
Alina Solomon, MD, PhD, Adjunct professor · University of Eastern Finland
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 60 Years
- Max Age
- 77 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-09-30
- Primary Completion
- 2013-12-31
- Completion
- 2025-12-31
Countries
- Finland
Study Locations
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