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NCT Number: NCT06218121

Update on the Detection of Frailty in Older Adults

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.

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Key information

Age range

62 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Puerta de Hierro de Majadahonda

Madrid, Outside of the US, 28222, Spain

Location status: Recruiting

Location contact

Eleuterio A. Sánchez Romero, PhD

CONTACT

[email protected]

617123563

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Ultrasound Imaging to Study Sarcopenia and Nutrition, Psychological Variables.

Primary outcomes

  1. Manual Grip Strength

    Time frame: Baseline

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

  2. Quality of Life (EQ-5D-5L)

    Time frame: Baseline

    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).

  3. Basic Activities in Daily Life

    Time frame: Baseline

    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 .

  4. Balance

    Time frame: Baseline

    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).

  5. Visual Analog Scale (VAS)

    Time frame: Baseline

    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.

  6. Strength

    Time frame: Baseline

    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.

  7. Anxiety

    Time frame: Baseline

    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.

  8. Kinesiophobia

    Time frame: Baseline

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

  9. Depression

    Time frame: Baseline

    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.

  10. Risk of Falls

    Time frame: Baseline

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Eleuterio A. Sánchez Romero, PhD

CONTACT

[email protected]

+34 617 123 563

Sponsors and collaborators

Lead sponsor

Universidad Europea de Madrid

Other

Registry information

Official study title

Update on the Detection of Frailty in Older Adults: A Multicenter Cohort Machine Learning-Based Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 23, 2024
Registry last updated
Jul 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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