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Aging FrailtyAGE-ITNCT07109596

Integration of Clinical, Biological and Psycho-social Variables for a Gender-sensitive Frailty Prediction

An observational study of Aging Frailty, run by University of Roma La Sapienza at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The progressive aging of the population worldwide yields profound health and social implications. Aging entails a progressive impairment of functions and, ultimately, leads to increased susceptibility to morbidity and mortality. Unsurprisingly, over 85% of people over 75 years of age suffer from chronic diseases. Read more about this study

Who is it for?
Ages 56 years and older
Conditions the study is for
Aging Frailty
How many people
1,000 participants
Where
1 siteItaly
Study dates
1 Jun 2025to 31 Dec 2028
Phase
Observational
Are there results?
Not yet: the study is under way

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 56 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: For the primary objective, we plan to recruit at least 1000 subjects (M:F=1:1)

Who may be able to join

  • patients admitted in internal medicine or geriatric units
  • age > 55 years

Who cannot join

  • Surgical patients, critical illness requiring admission to an intensive care unit, presence of an active malignancy.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Valeria Raparelli contact

age-it.dmtp@uniroma1.it

Italy1 site, 1 recruiting
  • Sapienza University of Rome, University Hospital Policlinico Umberto I, Rome - UOC Internal medicine and Immunology

    Roma, 00185

    Stefania Basili, +393393452523, stefania.basili@uniroma1.it

    Recruiting

Other trials in Italy

About this study

Official title: Integration of Clinical, Biological and Psycho-social Variables for a Gender-sensitive Frailty Prediction (Age-It: Ageing Well in an Aging Society - A Novel Public-private Alliance to Generate Socioeconomic, Biomedical and Technological Solutions for an Inclusive Italian Ageing Society)

The progressive aging of the population worldwide yields profound health and social implications. Aging entails a progressive impairment of functions and, ultimately, leads to increased susceptibility to morbidity and mortality. Unsurprisingly, over 85% of people over 75 years of age suffer from chronic diseases. Notwithstanding, healthcare systems, usually organized for acute conditions, are not structured to provide effective and efficient care for chronic conditions. Patients with chronic conditions often present a complex interplay of multimorbidity, polypharmacy and frailty. These determinants of health, which are tightly intertwined, are further modulated and influenced by several characteristics of patients, including sex, socio-economic factors and the broad spectrum of the so - called gender-related characteristics of the individuals. The combination of these determinants - whose interaction is often unpredictable - contribute to defining the prognosis of these patients.

Frailty is proposed as a state of increased vulnerability and strongly characterizes the older population (Clegg A, Lancet 2013; 381: 752-62). Nonetheless, older age does not always imply a condition of frailty. The development of a simple frailty index can be useful in clinical practice to stratify patients according to their level of frailty, taking into account the specific gender peculiarities, and may facilitate the appropriate tailoring of social- and health-related interventions. One of the factors that accelerates biological aging and increases susceptibility to frailty is a chronic, low-grade and systemic inflammation known as inflammaging. (Ferrucci L, et al. Nat Rev Cardiol 2018). Aging-associated platelet hyperreactivity is driven by chronic inflammation (Pavel Davizon-Castillo et al. Blood 2019) and is associated with chronic age-related cardiovascular disease and mortality. In turn activated platelets fuel inflammation creating a vicious cycle known as thromboinflammation. Both the hemostatic and the immune system display sexual dimorphism and are susceptible to gender-related factors, such as diet, stress, workload, etc. Identification of thromboinflammatory biomarkers could be a novel valuable asset to understand and predict frailty in a more sex and gender sensitive manner in the aging population.

Read more

Another aging feature is malnutrition, which can significantly contribute to quality of life and clinical outcomes. In particular, the age-related progressive loss of muscle mass and function (i.e.,sarcopenia) reduces the autonomy of older adults, impinges on their quality of life and reduces the tolerance to chronic as well acute therapeutic interventions. Recent evidence suggests that sarcopenia could be considered as a proxy for biological age (Mandelblatt et al. JAMA Oncol 2021). Therefore, timely diagnosis and treatment of impending malnutrition and sarcopenia could ameliorate not only patients' quality of life but survival as well (Bargetzi L et al. Ann Oncol 2021). Sarcopenia and inflammation are associated with osteoarthritis, the most common degenerative joint disease and a leading cause of frailty and disability in the elderly (Wang H, et al. Plos One 2022). The frailty Index (alone or associated with biomarkers) may not include all factors that impact life expectancy yet. It is a well-described clinical phenomenon that females live longer than males yet tend to experience greater levels of co-morbidity and disability. Gender-sensitive factors may be relevant in this context. Expectations and responsibilities associated with gender roles may contribute to the willingness (and ability) of the sexes to adopt a "sick" role, seek help and access to health care (Hibbard JH, et al. Women Health 1986). While social vulnerability is weakly to moderately correlated with frailty in both sexes, females are more socially vulnerable than males due to their living situation (widowhood and living alone) (Andrew MK, et al. BMC Geriatrics 2014). Even so, females may be better able to cope with higher levels of frailty due to greater social support networks.

Males may be more vulnerable to the effects of social isolation, particularly widowhood, both in terms of frailty and mortality (Shor E, et al. Demography 2012). In conclusion, clinical, biological, social and behavioral factors (captured by gender) may contribute to the frailty burden. To date, few studies have presented frailty scores stratified by sex and, overall, results have not been consistent (Gordon EH, et al. Maturitas 2018). Appropriate tailoring of social- and health-related interventions is critical to reduce potential harm from inappropriate procedures and maximize benefits from therapeutic intervention in such a complex population. Stratification of patients based on their gender and frailty status has the potential to tailor their care more precisely, shift the emphasis in medicine from reaction to prevention and reduce the health cost burden.

Read the detailed description

Objective of the study The primary objective of the study is to provide a framework to assess the sex and gender effect in aging research by creating a gender-oriented frailty index score and by developing an AI tool to make it applicable in clinical practice both during and after hospitalization.

As a secondary objective we will investigate the relationship between the nutritional and the thrombo-inflammatory status with the gender-oriented frailty index.

Conditions
Aging Frailty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sex and gender specific frailty index

    provide a framework to assess the sex and gender effect in aging research by creating a gender-oriented frailty index

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2025
  2. Study start1 Jun 2025
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07109596
Sponsor's protocol ID
7139
Acronym
AGE-IT
Status last verified
Mar 2025
First submitted
31 Jul 2025
Last updated
7 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Aging Frailty, run by University of Roma La Sapienza 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 7 Aug 2025. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Stefania Basili (+393393452523, stefania.basili@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sex and gender specific frailty index (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 7 Aug 2025.

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