ItaliaN Study With Tailored Multidomain Interventions to Prevent Functional and Cognitive Decline in Community-dwelling Older Adults

Status: Recruiting
Location: See location...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: t
View:

• 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

• Presence of increased risk of developing dementia by family history (≥ 1 family member with dementia) and/or at least one modifiable risk factor, with Lifestyle Index ≥2. Lifestyle index evaluation: each Yes answer to the following questions = 1 point.

‣ Physical activity less than 2.5 hours per week (defined as physical activity intense enough to lead to sweating and breathlessness)\*

⁃ Diet: less than 5 servings of fruits and vegetables per day\*

⁃ Diet: less than 2 servings of fish per week\*

⁃ Hypertension: diagnosed by a physician or on medication, or Systolic Blood Pressure (SBP)\>140 mmHg, or Diastolic Blood Pressure (DBP)\>90 mmHg)

⁃ Diabetes: type 1 or type 2 diagnosed by a physician, or on medication, or HbA1C ≥7 % in the previous 6 months

⁃ Sleep disturbances, depressive symptoms, or mental/physical stress symptoms, for at least 1 month, judged by the physician to be disabling in daily life

⁃ BMI ≥ 25 kg/m\^2\*

⁃ Alcohol: \> 21 alcohol units/week\*. \*Based on international and WHO guidelines.

• Informed consent freely given and acquired before the start of the study

Locations
Other Locations
Italy
Fondazione IRCCS San Gerardo dei Tintori
RECRUITING
Monza
Contact Information
Primary
Carlo Ferrarese
carlo.ferrarese@unimib.it
0392333595
Time Frame
Start Date: 2024-07-16
Estimated Completion Date: 2026-03
Participants
Target number of participants: 1340
Treatments
Experimental: Active intervention arm
* Physical exercise regime~* Mediterranean diet-based nutritional plan~* Cognitive training~* Regular medical check-ups~* Oral hygiene treatments and counseling~* Counseling on sleep hygiene and treatment~* Control of cardiovascular, metabolic, and infectious risk factors~* Adjustment of drug therapy~* Suggestions for improving social interactions~Physical exercise and cognitive training interventions will be monitored and partially administered through wearable devices and digital tools. Sleep quality will be monitored through wearable devices. Social interactions will be encouraged through a validated app.
Active_comparator: Self-administered intervention arm
Subjects in the control group will receive regular health advice in the same domains as the intervention group, via dedicated app and/or access to the dedicated portal on the Age-It website.~In addition, participants randomized to the self-guided intervention will receive an initial 30-60 minute counseling session on all domains covered by the study, in which guidelines for healthy diet, physical and cognitive activity, benefits of social activity, information on cardiovascular risk factors, as well as sleep, oral hygiene will be explained.~Subjects will therefore be treated as per normal clinical practice, albeit with the help of dedicated apps and counseling session.
Sponsors
Collaborators: European Union
Leads: University of Milano Bicocca

This content was sourced from clinicaltrials.gov