NCT Number: NCT06490783
The purpose of the present study is to evaluate the effectiveness of using multi-parameter monitoring devices in the elderly to improve their quality of life not already understood as the absence of disease but in a logic that is intrinsically linked to the body-mind relationship, which is increasingly significant as biological age advances. The study will be conducted on a sample of volunteer elderly subjects who will wear devices capable of constantly monitoring vital parameters such as heart rate, physical activity, sleep quality, stress levels and higher level activities, linked sensory and cognitive aspects ecologically integrated with the elderly person's living environment, in the sense of an evaluative and qualitative focus on relationships within the person's area of action/interaction, possibly supported and stimulated by individualized and easily usable activities. The signals interpreted and returned by the technology to the elderly person who uses it can also act as a reassuring self-assessment of even normal body states, sometimes experienced as threatening and anxiogenic, thus stressful. The collection and management of these data may serve as a reference to the recognition of distress signals and complex experiences (e.g., depressive) that normally have significant effects on mental health, understood as intrinsically linked to the health of the body.
Interested in participating?
Request Info60 year and older
All sexes
Observational
Messina, 98164, Italy
Location status: Recruiting
Gaspare Cusimano
SUB_INVESTIGATOR
Gennaro Tartarisco
PRINCIPAL_INVESTIGATOR
Roberta Bruschetta
SUB_INVESTIGATOR
Rosanna Turrisi
SUB_INVESTIGATOR
Serena Iacono Isidoro
CONTACT
Serena Iacono Isidoro
SUB_INVESTIGATOR
Simona Campisi
SUB_INVESTIGATOR
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Each enrolled subject will be equipped with noninvasive wearable devices (smartwatch and heart rate monitor band) to monitor physiological parameters and emotional states related to anxiety and stress. Each subject will be required to wear the smartwatch on his or her wrist for the duration of the study, about 3-6 months; while the heart rate monitor band will be worn for about 10 minutes a day. At the same time, a mobile application, RESILIENT, will be developed and implemented to serve as the main interface for self-assessment data entry and for feedback and recommendations.
The psycho-physical condition of each subject will be monitored by the app through customized and contextualized mental exercises based on daily activities. This approach will test the effectiveness of the proposed architecture in reducing unhealthy habits and promoting health and wellness recommendations
Time frame: Through study completion, an average of 1 year
The chest strap Polar H10 uses an electrocardiogram (ECG) sensor to detect the electrical activity of the heart and calculate heart rate in beats per minute (bpm).
Time frame: Through study completion, an average of 1 year
The chest strap Polar H10 measures the time intervals between successive heart beats and calculates Heart Rate Variability (HRV) in milliseconds (ms).
Time frame: Through study completion, an average of 1 year
The smartphone's camera records facial expressions in order to evaluate and quantify human emotions.
The Artificial Intelligence (AI) algorithms, recognizing the human face, identify important facial features and examine them to categorize different facial emotions. The emotions associated with these facial expressions are then extracted.
Time frame: Through study completion, an average of 1 year
This refers to the total number of times each subject take a step with either foot. It's a basic unit to measure overall activity level. Fitness trackers typically use steps to monitor movement throughout the day.
Time frame: Through study completion, an average of 1 year
This indicates the actual physical length each subject covered during activity. It's usually measured in miles or kilometers. Distance traveled can be calculated based on the number of steps you take and your stride length (the distance between two consecutive footfalls with the same foot).
Time frame: Through study completion, an average of 1 year
This refers to the amount of energy each subject's body expends during activity. It's measured in calories (kcal). The number of calories burned depends on various factors like weight, height, activity intensity (e.g., walking vs running), and duration. Fitness trackers typically estimate calorie burn based on steps taken, distance traveled, and personal information.
Contact information is provided by the study sponsor or research team.
Gennaro Tartarisco
CONTACT
Maria Valeria Maiorana
CONTACT
Istituto per la Ricerca e l'Innovazione Biomedica
Other
CybeR-human systEms for perSonalIzed mentaL and physIcal wEll-beiNg and Health
Acronym: RESILIENT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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