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

No results posted yet for this study

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
  • Karolinska Institutet

    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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01041989 on ClinicalTrials.gov