Prevention of Disability in the Frail Elderly Person Through an Innovative Customised and Multidimensional Training Programme

NCT06377436 | Recruiting DMC

• 1 other identifier: PRAISE
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty

Keywords

Frailty; cognitive function; elderly

Outcome Measures

Primary Outcomes (3)

• Changes in the Functional decline

  Functional decline defined and measured by a reduction in ability to perform self-care activities of daily living (ADL) because of a decrement in physical or cognitive functioning or in 1 of 5 domains of intrinsic capacity (IC). Functional decline will be measured using Frailty Checklist (score range 0-18; 0=not frail- 18 Severe frailty) and Short Physical Performances Battery (SPPB; scores range from 0 = worst performance to 12 =best performance).

  through training completion, ( 1 year after training)

• Intrinsic Capacity (IC)

  Quantitative assessment of the five domains of the IC. Each domain will be measured using specific test. 1. Cognition : Mini Mental State Examination (score range 0-30) , Fluency test, 15 Rey's words, H cancellation test (for the last three test the equivalent score is used - range 0=patological-4-better normal performance) 2. Locomotion: Six minutes walking test, Timed Up and Go test (TUG) and cognitive TUG; 3. Sensory: vision test and Whisper test for the hearing; 4. Vitality: handgrip-strength and Mini Nutritional assessment. 5. Psychological domain: Hospital Anxiety and Depression Scale (A total subscale score of \>8 points out of a possible 21 denotes considerable symptoms of anxiety or depression.) The interaction effect, among the 5 domains of the IC, will be measured using Spearman's rank correlation coefficient. This identifications it allows whether the intervention on specific domains of the IC will spread the favourable effect on others as well.

  through training completion, ( 1 year after training)

• Intreaction between IC and cardiac autonomic control (CAC)

  The association between IC and CAC (10 minutes ECG in rest and stand) . Application. Effect on CAC. This is indeed enhanced by interventions that can influence performance and individual functioning such as physical/mental training.

  through training completion, ( 1 year after training)

Study Arms (2)

DIVIDAT SENSO GROUP

EXPERIMENTAL

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)

Behavioral: Experimental training

STANDARD OF CARE GROUP

NO INTERVENTION

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.

Interventions

Experimental training BEHAVIORAL

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.

DIVIDAT SENSO GROUP

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

Gabriella CERRI

Milan, 20100, Italy

RECRUITING

Related Publications (14)

• Bakker J, Donath L, Rein R. Balance training monitoring and individual response during unstable vs. stable balance Exergaming in elderly adults: Findings from a randomized controlled trial. Exp Gerontol. 2020 Oct 1;139:111037. doi: 10.1016/j.exger.2020.111037. Epub 2020 Jul 28.

  PMID: 32730797 BACKGROUND

• Carlesimo GA, Caltagirone C, Gainotti G. The Mental Deterioration Battery: normative data, diagnostic reliability and qualitative analyses of cognitive impairment. The Group for the Standardization of the Mental Deterioration Battery. Eur Neurol. 1996;36(6):378-84. doi: 10.1159/000117297.

  PMID: 8954307 BACKGROUND

• Guyatt GH, Sullivan MJ, Thompson PJ, Fallen EL, Pugsley SO, Taylor DW, Berman LB. The 6-minute walk: a new measure of exercise capacity in patients with chronic heart failure. Can Med Assoc J. 1985 Apr 15;132(8):919-23.

  PMID: 3978515 BACKGROUND

• Guigoz Y, Vellas B, Garry PJ. Assessing the nutritional status of the elderly: The Mini Nutritional Assessment as part of the geriatric evaluation. Nutr Rev. 1996 Jan;54(1 Pt 2):S59-65. doi: 10.1111/j.1753-4887.1996.tb03793.x. No abstract available.

  PMID: 8919685 BACKGROUND

• Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94. doi: 10.1093/geronj/49.2.m85.

  PMID: 8126356 BACKGROUND

• Maguire, N., Prosser, S., Boland, R., & McDonnell, A. (1998). Screening for hearing loss in general practice using a questionnaire and the whisper test. The European Journal of General Practice, 4(1), 18-21.

  BACKGROUND

• Gordon, W.A., Ruckdeschel-Hibbard, M., Egelko, S., Diller, L., Simmens, S., Langer, K. (1984). Single Letter Cancellation Test in Evaluation of the Deficits Associated with Right Brain Damage: Normative Data on the Institute of Rehabilitation Medicine Test Battery. New York: New York University Medical Center

  BACKGROUND

• Novelli, P., Capitani, L., Vallar, C., & Cappa, S. (1986). Test di fluenza verbale. Archivio di Psicologia, Neurologia e Psichiatria, 47(4), 477-506.

  BACKGROUND

• Pavey TG, Gomersall SR, Clark BK, Brown WJ. The validity of the GENEActiv wrist-worn accelerometer for measuring adult sedentary time in free living. J Sci Med Sport. 2016 May;19(5):395-9. doi: 10.1016/j.jsams.2015.04.007. Epub 2015 Apr 17.

  PMID: 25956687 BACKGROUND

• 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.

  PMID: 1991946 BACKGROUND

• 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.

  PMID: 18826625 BACKGROUND

• 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.

  PMID: 1512391 BACKGROUND

• 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.

  PMID: 6880820 BACKGROUND

• 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.

  PMID: 998716 RESULT

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Gabriella GC CERRI, Full Professor

CONTACT

+393402527675; gabriella.cerri@unimi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: April 22, 2024
• Study Start: March 20, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)