Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05785260 |
| Other study ID # |
BRAINHEART22 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 27, 2022 |
| Est. completion date |
December 31, 2022 |
Study information
| Verified date |
March 2023 |
| Source |
IRCCS Centro Neurolesi "Bonino-Pulejo" |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
The objective of the study is to develop a smartphone application dedicated to health
prevention in terms of monitoring physical activity and healthy eating, mediated by the use
of Mindfulness-ACT exercises to reduce unhealthy lifestyles and monitoring through the use of
engineered wearable bands.
This is a nonpharmacological prospective observational study. The procedure includes
consecutive enrollment in the study of 40 subjects who meet all inclusion criteria. Patients
will undergo comprehensive cognitive assessment with collection of all medical history data
and information on current clinical condition, including dietary lifestyle. After that they
will be invited to register on Brainhearth platform, and then via the app monitoring of
physical activity and nutrition, mediated by the use of Mindfulness-ACT exercises, will take
place.
Description:
The Brainheart study aims to develop a smartphone application connected to a smartwatch
dedicated to the prevention of cardiovascular disease among the elderly in their activities
of daily living. In addition, to promote health by monitoring physical activity through
special engineered bands and healthy eating, mediated by the use of Mindfulness-ACT exercises
and appropriate dietary regimen, according to the attached scheme (Appendix A);to acquire
physiological and behavioral correlates through the BRAINHEART platform;to develop physical
activity, nutrition and interactive exercise programs based on MCBT and ACT; administering
contextualized MCBT and ACT cognitive behavioral exercises to promote program
adherence;enhancing meta-cognitive skills through a better understanding of the individual
with respect to his or her own cognitive processes and their functioning;improving quality of
life and one's mental and physical well-being;increasing scientific and clinical knowledge
for mental and physical well-being and strategies to promote it;increasing sense of
self-efficacy and self-esteem. To achieve these goals, the application developed on a mobile
platform, will be designed by integrating:
- a multi-sensory wearable device capable of acquiring and processing physiological and
behavioral data to monitor physical and mental health status
- advanced artificial intelligence-based decision support models that can recognize
physical and mental health status and provide personalized physical activity and
nutrition programs
- exercises and interactive games based on the cognitive behavioral technique Mindfulness
and ACT, contextualized and customized in order to increase awareness of health status
and motivate the elderly to pursue a healthy lifestyle and best follow the
cerebrocardiovascular disease prevention program
STUDY DESIGN.
This is a nonpharmacological prospective observational study.
DURATION OF THE STUDY
Overall, the study will have a duration of 12 months.
STUDY POPULATION
A total of 40 subjects will be consecutively enrolled in the study who are afferent to the
facility's outpatient clinics and meet all inclusion criteria, and who will be evaluated at
the time of recruitment (T0), and at 6 (T1) and 12 months (T2) intervals. All patients will
be assessed by the (a) MMSE, (b) batteries provided within the Brief Neuropsychological
Examination, (c) quality of life assessment questionnaires, and (d) Mini Nutritional
Assessment (see Annex A to this protocol).
Inclusion criteria
- Age of subjects: 50-85 years.
- Subjects with global cognitive functioning at normal limits (MMSE ≥ 20)
- Subjects with a diagnosis of mild and/or absent depression
Exclusion criteria.
- Diagnosis of dementia
- Diagnosis of moderate/severe depression
- Speech disorders;
- Psychiatric disorders;
- Praxic deficits.
Materials
The project involves the use of:
- portable devices with adequate computational and memory capabilities;
- wireless wearable sensors capable of simultaneously measuring heart rate (HR), and
physical activity using triaxial accelerometer;
- mobile processing units for extraction of biosignal features and automatic
classification of stress levels.
