StrengthNCT06218121
Update on the Detection of Frailty in Older Adults
An observational study of Strength and Quality of Life, run by Universidad Europea de Madrid at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 62 years and older
- Conditions the study is for
- Strength, Quality of Life, Functional Independence
- What is being tested?
- Instrumental and Functional Tests that Assess Functional Capacity
- How many people
- 500 participants
- Where
- 1 siteSpain
- Study dates
- 20 Apr 2024to 15 Jun 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 62 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Puerta de Hierro de Majadahonda
Madrid, Outside of the US, 28222
Eleuterio A. Sánchez Romero, PhD, 617123563, eleuterio.sanchez@universidadeuropea.es
About this study
Official title: Update on the Detection of Frailty in Older Adults: A Multicenter Cohort Machine Learning-Based Study
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.
Read the detailed description
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
- Strength, Quality of Life, Functional Independence, Functionality, Pain, Sarcopenia
- Being tested
- Instrumental and Functional Tests that Assess Functional Capacity
- Keywords
- Frailty, Quality of life, Sarcopenia, Ultrasound
- Medical subject headings
- Pain, Sarcopenia, Anxiety Disorders, Kinesiophobia, Depression, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrumental and Functional Tests that Assess Functional CapacityDiagnostic test
Also called Ultrasound Imaging to Study Sarcopenia and Nutrition, 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Instrumental and Functional Tests that Assess Functional Capacity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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 .
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Kinesiophobia
Kinesiophobia was measured with Spanish version of Tampa Scale of Kinesiophobia. Higher scores denotes greater fear of experiencing pain while moving.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start20 Apr 2024
- Primary completion15 Apr 2025 (estimated)
- Study completion15 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrengthStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eleuterio Atanasio Sánchez Romero, Universidad Europea de Madrid
- Investigators
- Eleuterio A. A. Sánchez Romero, PhD, Principal investigator, European University of Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06218121
- Sponsor's protocol ID
- Detection of Frailty
- Status last verified
- Jul 2024
- First submitted
- 2 Jan 2024
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40413725
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Update on the Detection of Frailty in Older Adults: A Multicenter Cohort Machine Learning-Based Study
- ClinicalTrials.gov ID
- NCT06218121
- Acronym / sponsor ID
- Detection of Frailty
- Conditions
- Strength, Quality of Life, Functional Independence, Functionality, Pain, Sarcopenia
- Keywords
- Frailty, Quality of life, Sarcopenia, Ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- 20 Apr 2024 (actual)
- Primary completion
- 15 Apr 2025 (estimated)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 23 Jan 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 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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Frail Older Adult Patients | – | Diagnostic Test: Instrumental and Functional Tests that Assess Functional CapacityFor 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. |
Who may qualify
- Ages
- 62 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (9 listed)
- 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)
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 |
|---|---|---|
| Instrumental and Functional Tests that Assess Functional CapacityAlso: Ultrasound Imaging to Study Sarcopenia and Nutrition, 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. | Diagnostic test | Frail Older Adult Patients |
Primary outcome
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.
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).
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 .
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).
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.
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Derived from this study: PubMed 40413725Fernandez-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.
- 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.
Eleuterio A. A. Sánchez Romero, PhD principal investigator
European University of Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Strength and Quality of Life, run by Universidad Europea de Madrid at 1 site in Spain.
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 1 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 9 Jul 2024. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eleuterio A. Sánchez Romero, PhD (+34 617 123 563, eleuterio.sanchez@universidadeuropea.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Manual Grip Strength (time frame: Baseline). The study lists 10 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 NCT06218121, which also lists 1 linked publication.
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 9 Jul 2024.