Update on the Detection of Frailty in Older Adults

NCT ID: NCT06218121

Last Updated: 2024-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-20

Study Completion Date

2025-06-15

Brief Summary

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The main objective is to update the diagnostic assessment of frailty by correlating several variables with the ultrasound image of the frail elderly patient.

Secondarily, the investigators intend to collect and analyze data on functional capacity and quality of life variables on the evolution of musculoskeletal symptoms, as well as on pain and psychological variables. Similarly, it is intended to make a record of different profiles and subtypes of frail older adult patients to be stored in Machine Learning in order to establish therapeutic intervention plans that allow both the evaluation and treatment of patients.

Detailed Description

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The present cohort study will be conducted in 500 older adults diagnosed with frailty.

The correlation of the demographic variables, physical functionality tests and psychoemotional constructs that will be analyzed in this study with the ultrasound image obtained from the patients will improve the ultrasound diagnosis of frailty, providing new information that will facilitate the work of healthcare personnel in the diagnosis and management of frailty.

Similarly, the use of Machine Learning will allow institutions to extract data on different patient profiles, signs and symptoms of frailty and the different risk factors that affect frailty patients, which will improve treatments and favor the development of educational programs tailored to the patient's needs.

Conditions

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Strength Quality of Life Functional Independence Functionality Pain Sarcopenia Anxiety Kinesiophobia Depression

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Frail Older Adult Patients

For the cohort study, 500 frail older adult patients will be evaluated by means of instrumental and functional tests that assess their functional capacity, in addition to ultrasound imaging to study sarcopenia and nutrition, as well as psychological variables. The correlation between all functional, ultrasound, nutritional, and psychological variables will be analyzed. Through GLIM diagnosis, anthropometric data (weight, height, BMI) as well as analytical data including inflammation information (CRP and albumin) will be used to reach a diagnosis that allows comparison/correlation with the rest of the variable parameters. All available information will be collected during the follow-up in order to generate Machine Learning on the objective evolution and symptomatology of these patients, generating profiles that facilitate the most accurate and appropriate treatment for each patient.

Instrumental and Functional Tests that Assess Functional Capacity

Intervention Type DIAGNOSTIC_TEST

The correlation between all functional, ultrasound, nutritional, and psychological variables will be analyzed. Through GLIM diagnosis, anthropometric data (weight, height, BMI) as well as analytical data including inflammation information (CRP and albumin) will be used to reach a diagnosis that allows comparison/correlation with the rest of the variable parameters.

Interventions

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Instrumental and Functional Tests that Assess Functional Capacity

The correlation between all functional, ultrasound, nutritional, and psychological variables will be analyzed. Through GLIM diagnosis, anthropometric data (weight, height, BMI) as well as analytical data including inflammation information (CRP and albumin) will be used to reach a diagnosis that allows comparison/correlation with the rest of the variable parameters.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Ultrasound Imaging to Study Sarcopenia and Nutrition Psychological Variables.

Eligibility Criteria

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Inclusion Criteria

A diagnosis of signs and symptoms of frailty by a geriatric physician in the research group will be used as the primary inclusion criterion. Frailty will be assessed and diagnosed using the frailty phenotype and the Clinical Frailty Scale.

Exclusion Criteria

* Acute myocardial infarction in the last 3 months and/or unstable angina pectoris
* Uncontrolled arrhythmia, recent thromboembolism and terminal illness.
* Patients undergoing MMII unloading or MMSS/MMII fractures in the last three months.
* Patients with a functional gait index of 1 (Inability to walk)
* Severe pain (7/10 VAS)
* Previous neuromuscular pathology presenting with weakness
* Medication that does not allow the patient's actual muscle reaction to be assessed
* Severe cognitive impairment that would prevent collaboration and understanding of the tests to be performed.
* Cardiovascularly unstable patients and uncontrolled arterial hypertension.
Minimum Eligible Age

62 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Europea de Madrid

OTHER

Sponsor Role lead

Responsible Party

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Eleuterio Atanasio Sánchez Romero

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eleuterio A. A. Sánchez Romero, PhD

Role: PRINCIPAL_INVESTIGATOR

European University of Madrid

Locations

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Hospital Puerta de Hierro de Majadahonda

Madrid, Outside of the US, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Eleuterio A. Sánchez Romero, PhD

Role: CONTACT

+34 617 123 563

Facility Contacts

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Eleuterio A. Sánchez Romero, PhD

Role: primary

617123563

References

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Fernandez-Carnero S, Martinez-Pozas O, Pecos-Martin D, Pardo-Gomez A, Cuenca-Zaldivar JN, Sanchez-Romero EA. Update on the detection of frailty in older adults: a multicenter cohort machine learning-based study protocol. Aging (Albany NY). 2025 May 21;17(5):1328-1339. doi: 10.18632/aging.206254. Epub 2025 May 21.

Reference Type DERIVED
PMID: 40413725 (View on PubMed)

Other Identifiers

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Detection of Frailty

Identifier Type: -

Identifier Source: org_study_id

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