Update on the Detection of Frailty in Older Adults

NCT06218121 | Recruiting

• 1 other identifier: Detection of Frailty
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Frailty; Quality of life; Sarcopenia; Ultrasound

Outcome Measures

Primary Outcomes (10)

• Manual Grip Strength

  The grip strength in both hands will be measured by measuring the maximum grip strength. A bulb dynamometer will be used for this measurement.

  Baseline

• Quality of Life (EQ-5D-5L)

  It will be evaluated by means of the the EuroQol 5-dimensions 5-levels (EQ-5D-5L), which is a generic instrument for measuring health-related quality of life. The patient himself assesses his state of health, in levels of severity by dimensions The first allows the respondent to define the state of health according to the EQ-5D multi-attribute classification system, composed of 5 dimensions (mobility, self-care, activities of daily living, pain/discomfort and anxiety/depression), and in each of them there are 3 levels of severity (1, 2 or 3).

  Baseline

• Basic Activities in Daily Life

  The Barthel Index evaluated one's ability to care for him/herself through ten activitiesof daily living like feeding, bathing, grooming, dressing, bowel and bladder control,toileting, chair transfer, ambulation, and stair climbing; the maximum score is 100 pointsand the higher the score, the greater the functional independence of the patient. Thefollowing baseline data regarding age, sex, and admission diagnosis were also collected .

  Baseline

• Balance

  The Trunk Control Test (TCT) evaluated four aspects of trunk movement, swinging to both sides, sitting balance, and rising from the floor; individual items are scored from 0 (incapable) to 12 (ability to perform the movement but with an unusual style) and 25 (ability to perform the movement correctly).

  Baseline

• Visual Analog Scale (VAS)

  To evaluate the pain that the patient has, we use the VAS. This is a 100 mm line that measures pain intensity. The left end of the line represents the absence of pain, while the right end represents the worst pain imaginable. The numerical pain intensity scale adds a numerical graduation where 1 is no pain and 10 is the worst pain imaginable. The confidence and reliability of this scale has been approved and validated in different studies.

  Baseline

• Strength

  The Medical Research Council Sum Score (MRCSS) strength assessment scale evaluated muscle strength in the upper and lower limbs. The different movements evaluated arescored from 0 to 5 and a maximum score of 60 can be obtained.

  Baseline

• Anxiety

  Anxiety was measured with Spanish version of State-trait Anxiety Inventory (STAI). Scores of 20-37 indicate no or low anxiety; 38-44 moderate anxiety; 45-80 high anxiety.

  Baseline

• Kinesiophobia

  Kinesiophobia was measured with Spanish version of Tampa Scale of Kinesiophobia. Higher scores denotes greater fear of experiencing pain while moving.

  Baseline

• Depression

  Depressive symptoms were measured with Spanish version of Beck Inventory II. 0-13 normal scores; 14-19 mild; 20-28 moderate; 29-63 severe depression.

  Baseline

• Risk of Falls

  Assessment of fall risk according to the Vivifrail protocol: cumulative number of falls in the past year, cumulative number of falls with physician care, suffer at least 1 fall in the past year, Timed Up and Go test (TUG) and existence of dementia to establish the existence of fall risk (+ or -); the TUG assesses the time it takes to get out of the chair, walk three meters, back to the chair, and to sit down.

  Baseline

Study Arms (1)

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.

Diagnostic Test: Instrumental and Functional Tests that Assess Functional Capacity

Interventions

Instrumental and Functional Tests that Assess Functional Capacity 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.

Also known as: Ultrasound Imaging to Study Sarcopenia and Nutrition, Psychological Variables.

Frail Older Adult Patients

Eligibility Criteria

• Age: 62 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The present cohort study will be conducted in older adults diagnosed with frailty. A multicenter study will be conducted among the Residencia de Nuestra Señora de la Soledad y del Carmen (Colmenar Viejo, Madrid), Residencia San Camilo (Tres Cantos, Madrid), Centro de Día San Camilo (Tres Cantos, Madrid), Residencia San Luis de Gonzaga (Carretera de Colmenar Viejo), Hospital Universitario Rey Juan Carlos (Móstoles, Madrid) and Hospital Puerta de Hierro (Majadahonda, Madrid) from their diagnosis

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Europea de Madrid: lead

Study Sites (1)

Hospital Puerta de Hierro de Majadahonda

Madrid, Outside of the US, 28222, Spain

RECRUITING

Related Publications (1)

• 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.

  PMID: 40413725 DERIVED

MeSH Terms

Conditions

Pain; Sarcopenia; Anxiety Disorders; Kinesiophobia; Depression; Frailty

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Mental Disorders; Phobic Disorders; Behavioral Symptoms; Behavior; Pathologic Processes

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Officials

• Eleuterio A. A. Sánchez Romero, PhD

  European University of Madrid

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eleuterio A. Sánchez Romero, PhD

CONTACT

+34 617 123 563; eleuterio.sanchez@universidadeuropea.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 23, 2024
• Study Start: April 20, 2024
• Primary Completion: April 15, 2025
• Study Completion: June 15, 2025
• Last Updated: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)