FrailtyPRAISENCT06377436
Prevention of Disability in the Frail Elderly Person Through an Innovative Customised and Multidimensional Training Programme
A study testing Experimental training in people with Frailty, run by University of Milan at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty
- What is being tested?
- Experimental training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 20 Mar 2023to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevenzione Della disabilità Nella Persona Anziana Fragile Attraverso un Innovativo Programma di Allenamento Personalizzato e Multidimensionale
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.
Read the 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.
- Conditions
- Frailty
- Being tested
- Experimental training
- Keywords
- Frailty, cognitive function, elderly
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
- 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)
- Locomotion: Six minutes walking test, Timed Up and Go test (TUG) and cognitive TUG;
- Sensory: vision test and Whisper test for the hearing;
- Vitality: handgrip-strength and Mini Nutritional assessment.
- 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.
Measured: 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.
Measured: through training completion, ( 1 year after training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start20 Mar 2023
- Primary completion31 Dec 2025
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof.ssa Gabriella Cerri, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06377436
- Sponsor's protocol ID
- PRAISE
- Acronym
- PRAISE
- Status last verified
- May 2026
- First submitted
- 21 Mar 2024
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32730797Carlesimo 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.
PubMed 8954307Guyatt 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.
PubMed 3978515Guigoz 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.
PubMed 8919685Guralnik 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.
PubMed 8126356Maguire, 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.
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
Novelli, P., Capitani, L., Vallar, C., & Cappa, S. (1986). Test di fluenza verbale. Archivio di Psicologia, Neurologia e Psichiatria, 47(4), 477-506.
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.
PubMed 25956687Podsiadlo 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.
PubMed 1991946Searle 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.
PubMed 18826625Tombaugh 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.
PubMed 1512391Zigmond 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.
PubMed 6880820Bailey 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.
PubMed 998716
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevenzione Della disabilità Nella Persona Anziana Fragile Attraverso un Innovativo Programma di Allenamento Personalizzato e Multidimensionale
- ClinicalTrials.gov ID
- NCT06377436
- Acronym / sponsor ID
- PRAISE / PRAISE
- Conditions
- Frailty
- Keywords
- Frailty, cognitive function, elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 22 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DIVIDAT SENSO GROUP | Experimental | Behavioral: Experimental training40 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) |
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental trainingThrough 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. | Behavioural | DIVIDAT SENSO GROUP |
Primary outcome
Changes in the Functional decline
Time frame: through training completion, ( 1 year after training)
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).
Intrinsic Capacity (IC)
Time frame: through training completion, ( 1 year after training)
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.
Intreaction between IC and cardiac autonomic control (CAC)
Time frame: through training completion, ( 1 year after training)
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Background: PubMed 32730797Bakker 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.
- Background: PubMed 8954307Carlesimo 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.
- Background: PubMed 3978515Guyatt 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.
- Background: PubMed 8919685Guigoz 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.
- Background: PubMed 8126356Guralnik 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.
- BackgroundMaguire, 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.
- BackgroundGordon, 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
- BackgroundNovelli, P., Capitani, L., Vallar, C., & Cappa, S. (1986). Test di fluenza verbale. Archivio di Psicologia, Neurologia e Psichiatria, 47(4), 477-506.
- Background: PubMed 25956687Pavey 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.
- Background: PubMed 1991946Podsiadlo 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.
- Background: PubMed 18826625Searle 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.
- Background: PubMed 1512391Tombaugh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental training in people with Frailty, run by University of Milan at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the Functional decline (time frame: through training completion, ( 1 year after training)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06377436, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.