GOIZ ZAINDU Feasibility Multi Domain Trial to Prevent Dementia.
NCT ID: NCT06163716
Last Updated: 2023-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
125 participants
INTERVENTIONAL
2018-04-01
2020-03-01
Brief Summary
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Detailed Description
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After the baseline evaluation, all participants received in person verbal information on the potential benefits of caring for vascular risk factors, adhering to Mediterranean diet, and having good cognitive and physical activity routines. Participants were later randomly assigned to a standard health advice control group (RHA, control) or the multidomain intervention group (MD-Int). Random assignment followed a proportion of 1:1 and was stratified by age (\<75 years vs.≥75 years), sex, and cognitive status (normal cognition vs. MCI).
1. Regular health advice control (RHA) group. Participants randomized to the control group followed preventive programs already ongoing at their Primary Care Unit regarding physical activity, socialization, and smoking and alcohol usage. Visits to the GP and nurse depended on personal demands and necessities; nevertheless, annual consultation was recommended for all patients over 60 years old.
2. Multidomain intervention (MD-Int) group. The MD-Int program was designed to provide tools and routines that participants could incorporate into daily living activities and reinforce the social environment. Although the program included standardized guidelines and exercises, each participant was considered individually, adapting nutritional requirements and physical and cognitive activity according to individual needs and abilities. This methodology is based on the FINGER trial design\[23\] but has been adapted to local resources and the healthcare system. GPs and nurses were involved in the follow-up visits. Most intervention activities were carried out at the local Primary Care Centre. Local town hall resources such as group activities for older adults at the municipality sports centre and current outdoor sports activities were incorporated in the study. 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Regular health advice control (RHA) group.
Participants randomized to the control group followed preventive programs already ongoing at their Primary Care Unit regarding physical activity, socialization, and smoking and alcohol usage. Visits to the GP and nurse depended on personal demands and necessities; nevertheless, annual consultation was recommended for all patients over 60 years old.
No interventions assigned to this group
Multidomain intervention (MD-Int) group
The MD-Int program was designed to provide tools and routines that participants could incorporate into daily living activities and reinforce the social environment. Although the program included standardized guidelines and exercises, each participant was considered individually, adapting nutritional requirements and physical and cognitive activity according to individual needs and abilities. This methodology is based on the FINGER trial design but has been adapted to local resources and the healthcare system. GPs and nurses were involved in the follow-up visits. Most intervention activities were carried out at the local Primary Care Centre. Local town hall resources such as group activities for older adults at the municipality sports centre and current outdoor sports activities were incorporated in the study.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* had a CAIDE score ≥ 6 points and
* performed below than expected in at least one of two brief cognitive tests - Memory alteration test (T@M) and Fototest
* or scored two or higher in the AD8 informant's questionnaire of cognitive symptoms.
Exclusion Criteria
* or any situation, in the investigator's opinion, that could compromise safe engagement in the intervention.
60 Years
ALL
Yes
Sponsors
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Biogipuzkoa Health Research Institute
OTHER
Fundacion CITA-alzheimer
OTHER
Responsible Party
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Mikel Tainta
MD
Principal Investigators
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Mikel Tainta, MD
Role: PRINCIPAL_INVESTIGATOR
Study Principal Investigator
Pablo Martinez-Lage, MD, PhD
Role: STUDY_CHAIR
Scientific Director
Locations
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CITA-alzheimer
Donostia / San Sebastian, Gipuzkoa, Spain
Countries
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References
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Ngandu T, Lehtisalo J, Solomon A, Levalahti E, Ahtiluoto S, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M. A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial. Lancet. 2015 Jun 6;385(9984):2255-63. doi: 10.1016/S0140-6736(15)60461-5. Epub 2015 Mar 12.
Tainta M, Ecay-Torres M, de Arriba M, Barandiaran M, Otaegui-Arrazola A, Iriondo A, Garcia-Sebastian M, Estanga A, Saldias J, Clerigue M, Gabilondo A, Ros N, Mugica J, Barandiaran A, Mangialasche F, Kivipelto M, Arrospide A, Mar J, Martinez-Lage P; GOIZ ZAINDU study group. GOIZ ZAINDU study: a FINGER-like multidomain lifestyle intervention feasibility randomized trial to prevent dementia in Southern Europe. Alzheimers Res Ther. 2024 Feb 27;16(1):44. doi: 10.1186/s13195-024-01393-z.
Other Identifiers
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GZ trial
Identifier Type: -
Identifier Source: org_study_id