Prevention of Disability in the Frail Elderly Person Through an Innovative Customised and Multidimensional Training Programme
NCT ID: NCT06377436
Last Updated: 2024-04-22
Study Results
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Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2023-03-20
2024-12-31
Brief Summary
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The expected outcome is to slow down a functional decline not only in isolation in the domains trained by the program.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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DIVIDAT SENSO GROUP
40 frail subjects who will undergo the experimental training - "DIVIDAT SENSO training" on the Locomotor, Sensory and Cognitive domains. Traning wilk be performed at IRCCS Galeazzi-Sant'Ambrogio Hospital (5 non-consecutive sessions every 15 days, for 1 year)
Experimental training
Through The Dividat Senso intelligent platform, subjects will be subjected to locomotion, cognitive and sensory domain-specific exercise programs. The exercises will be of increasing difficulty. Cognitive exercises will in fact be carried out by interacting with the DIVIDAT device consisting of a monitor and a pressure-sensitive platform through weight shifts, multidirectional steps and jumps.
STANDARD OF CARE GROUP
40 frail subjects will be subjected to good practice rules for all 5 domains of the intrinsic capacity. Subject will be followed for 1 year. No specific supervised training will be administered to this group.
No interventions assigned to this group
Interventions
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Experimental training
Through The Dividat Senso intelligent platform, subjects will be subjected to locomotion, cognitive and sensory domain-specific exercise programs. The exercises will be of increasing difficulty. Cognitive exercises will in fact be carried out by interacting with the DIVIDAT device consisting of a monitor and a pressure-sensitive platform through weight shifts, multidirectional steps and jumps.
Eligibility Criteria
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Inclusion Criteria
* 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
* Neurodegenerative disease affecting locomotor or sensorial system;
* Dementia
65 Years
ALL
Yes
Sponsors
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University of Milan
OTHER
Responsible Party
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Prof.ssa Gabriella Cerri
Full professor
Locations
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Gabriella CERRI
Milan, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.
Searle SD, Mitnitski A, Gahbauer EA, Gill TM, Rockwood K. A standard procedure for creating a frailty index. BMC Geriatr. 2008 Sep 30;8:24. doi: 10.1186/1471-2318-8-24.
Tombaugh TN, McIntyre NJ. The mini-mental state examination: a comprehensive review. J Am Geriatr Soc. 1992 Sep;40(9):922-35. doi: 10.1111/j.1532-5415.1992.tb01992.x.
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
Bailey IL, Lovie JE. New design principles for visual acuity letter charts. Am J Optom Physiol Opt. 1976 Nov;53(11):740-5. doi: 10.1097/00006324-197611000-00006.
Other Identifiers
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PRAISE
Identifier Type: -
Identifier Source: org_study_id
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