Clinical trial NCT06377436: Prevention of Disability in the Frail Elderly Person Through an Innovative Customised and Multidimensional Training Programme
Official title: Prevenzione Della disabilità Nella Persona Anziana Fragile Attraverso un Innovativo Programma di Allenamento Personalizzato e Multidimensionale
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Frailty
Keywords: Frailty
cognitive function
elderly
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2024-04-22
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to implement a personalized training program to prevent functional decline in frail subjects but not yet disable. The purpose of the project is to test the training in a subject at particularly high risk of entering the disabled condition. A total of 80 frail subjects, divide the participants into two groups "Divida Senso Group" (experimental group) and "Standard of care Group" (Control group) will be recruited.

The expected outcome is to slow down a functional decline not only in isolation in the domains trained by the program.

Detailed description: INTRINSIC CAPACITY The "active and healthy" aging of each individual depends on the individual's "Intrinsic Capacity" (IC) and his or her interaction with the environment. Intrinsic Capacity is a composite index derived from the subject's assessment of 5 key domains on which the individual's perfect functionality is based. These domains are: Motricity (particularly locomotion), Sensory Competence (particularly referring to vision and hearing), Vitality (lifestyle), Cognitive Abilities, and Mood Status. The reduction in IC is physiological, but the rate at which the elderly person's functional reserve decreases can be variable, slower in some cases and faster in others, depending on various endogenous and environmental factors. Therefore, the elderly person is not inexorably destined for rapid decline as there is also a functional reserve in the aging organism.

CONSEQUENCES OF ISOLATION DUE TO THE COVID PANDEMIC The Covid pandemic produced very significant consequences especially for the elderly population. The isolation measures that were put in place during the pandemic highlighted, how much the drastic reduction in the ability to go out for common daily activities disrupted the lifestyle, reduced both motility and sociality of the elderly, possibly affecting the decline of intrinsic capacity. In addition, it was pointed out how lacking is the surveillance of the elderly in the area in terms of monitoring prevention and intervention.

THE FRAILTY CONDITION AND INDIVIDUAL AND SOCIAL CONSEQUENCES The rapid rate of decline in IC is very important as it can lead to frailty, a common geriatric condition characterized by extreme vulnerability of the body to stressors (endogenous and exogenous) with significantly increased risk of adverse health-related outcomes such as disability, institutionalization, hospitalization, and death. The consequences of frailty impair the individual's activity status and place a significant burden on the health care system. The annual health care cost per person in Europe can present a 3-fold increase depending on frailty status and care setting. However, frailty could potentially be reversible; its early detection should lead to the implementation of preventive strategies to correct abnormal deviations from the normal trajectory of aging by making the elderly population autonomous and active in society.

PURPOSE OF THE STUDY The project hypothesizes that frailty is caused by the subject's decline in IC, and thus can be considered a suitable model to test a training program targeting the domains of IC, with a focus on cognitive function, locomotion, and the sensory domain. The goal is to conduct a pilot study in frail elderly people in order to implement a personalized training program to prevent functional decline. The training will be conducted on a sensorized platform (DIVIDAT SENSO) capable of administering cognitive, motor, and dual task (integrated cognitive and motor) exercises. The purpose of the training is to improve the performance of the frail subject, and the evaluation of the training outcome will be done by comparing the results of the assessment battery at time T0, pre-training and T1 post-training. The DIVIDAT SENSO platform and all the instrumentation necessary for the assessment of the various performance domains of the subject are not the object of the study per se but a tool for its execution. An experimental population consisting of frail but not yet disabled individuals was chosen for the study. The choice of this condition for the study was based on the need to test the training in a subject at particularly high risk of entering the disabled condition (a so-called borderline subject, i.e., at the functional boundary between ability and disability) and losing independent living. The expected result is functional recovery not only in isolation in the domains trained by the program but, with a knock-on effect, on the others as well by going on to implement the entire IC. Significantly relevant results in this population would provide a solid scientific basis for the effectiveness of the program as it would affect a population already in very advanced stages of decline.

RELEVANCE AND PROSPECTS Having demonstrated the efficacy of training with the present project, it would be hoped to proceed with an extensive study on a larger population, over an extended study period, involving frail and non-frail subjects in order to verify the impact of training on the slope of physiological decline. Contextually, a network would be established to monitor the performance of the enrolled subjects, which transmitted to the primary care physician would allow active surveillance and the possibility of targeted intervention in case of pathological or borderline performance.

Eligibility criteria: Inclusion Criteria:

* Age \> 65 years,
* Fraiity index borderline based on the Searle scale (Searle et al.2008);
* Acceptance Agreement to take part in the study and signing of informed consent

Exclusion Criteria:

* Severe cognitive or motor deficits that make the patient unable to understand/fill out an informed consent or ambulate independently;
* Neurodegenerative disease affecting locomotor or sensorial system;
* Dementia

Primary outcomes:
measure: Changes in the Functional decline
timeFrame: through training completion, ( 1 year after training)
measure: Intrinsic Capacity (IC)
timeFrame: through training completion, ( 1 year after training)
measure: Intreaction between IC and cardiac autonomic control (CAC)
timeFrame: through training completion, ( 1 year after training)
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Gabriella CERRI
Study officials:
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