About this trial
The goal of this interventional non-pharmacological study is to investigate the effects of a multi-domain intervention ( "active intervention"), compared to that followed by normal clinical practice ("self-guided intervention"), in older adults. The primary objective is whether these interventions can prevent functional and cognitive decline in at-risk subjects.
The multi-domain interventions will include physical exercise, a Mediterranean diet-based nutritional plan, cognitive training, regular medical check-ups, oral hygiene treatments and counseling, monitoring and counseling on visual and auditory abilities, counseling on sleep hygiene and treatment, control of cardiovascular, metabolic, and infectious risk factors, adjustment of drug therapy, suggestions for improving social interactions.
Eligibility criteria
Qualifiers
Aged 60 or older
Mild/moderate vulnerability (Primary Care Frailty Index score between 0.07 and 0.21)
Cardiovascular risk factors, Ageing and Incidence of Dementia (CAIDE) > 6
Clinical Dementia Rating (CDR) ≤ 0.5
Disqualifiers
Diagnosis of dementia or suspected dementia following the screening visit
CDR > 0.5
Residents in residential facilities for the elderly
Inability to consent to informed consent and/or actively participate in study interventions, according to clinical judgment
Trial design
Treatments tested in this trial
- Nutritional intervention
- Physical exercise
- Cognitive training
- Oral hygiene
- Sleep quality
- Control of cardiovascular, metabolic, and infectious risk factors
- Pharmacological evaluation
- Socializing
- Self-administered interventions
Treatment groups
Sponsors and collaborators
University of Milano Bicocca
Lead sponsor
European Union
Collaborator