GOIZ ZAINDU Feasibility Multi Domain Trial to Prevent Dementia.
NCT06163716 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 125
Last updated 2023-12-11
Summary
GOIZ ZAINDU ("caring early" in Basque) is a pilot study to adapt the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) methodology to the Basque population and evaluate feasibility and adherence to a FINGER-like multidomain intervention program. Additional aims included the assessment of efficacy on cognition and collecting data to design a large efficacy trial.
Conditions
- Cognitive Decline
- Dementia Risk Factors
- Prevention
- Multidomain Intervention
Interventions
- BEHAVIORAL
-
Multidomain intervention (MD-Int) group
The MD-Int program included: 1) individual follow-up visits every three months for cardiovascular risk factor monitoring and nutritional counselling with primary health care providers; 2) two nutritional workshops led by a nutritionist; 3) 20 hours of cognitive stimulation delivered through group sessions and 4) 40 hours of individual cognitive training exercises. Participants in the MD-Int group received recommendations to practice 2 to 6 hours of physical exercise per week and get involved in sports activities. Social stimulation was promoted through group activities.
Sponsors & Collaborators
-
Biogipuzkoa Health Research Institute
collaborator OTHER -
Fundacion CITA-alzheimer
lead OTHER
Principal Investigators
-
Mikel Tainta, MD · Study Principal Investigator
-
Pablo Martinez-Lage, MD, PhD · Scientific Director
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-04-01
- Primary Completion
- 2020-03-01
- Completion
- 2020-03-01
Countries
- Spain
Study Locations
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