FrailtyECOFRAILNCT05294757
Development of Continuous Assessment of Frailty and Muscle Quality in Older Subjects: ECOFRAIL Protocol
A study testing Physical exercise in people with Frailty and Sarcopenia, run by University of Deusto at 3 sites in Spain.
Trial summary
We are conducting a study in different centers in Spain in elderly people, in order to assess the effectiveness of a physical exercise intervention program in people in a situation of frailty. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty, Sarcopenia, Ultrasonography
- What is being tested?
- Physical exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 3 sitesSpain
- Study dates
- 1 Mar 2022to 30 Jun 2024
- Phase
- Interventional
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age of at least 70 years old.
- Either gender.
- Ability to provide informed consent.
- Ability to perform all the functional tests.
- In the hospital exercise cohort, ability to perform the physical exercise program.
Who cannot join
- Expected survival inferior to one year.
- Barthel scale < 70.
- Moderate to severe cognitive impairment.
- Refuse to participate.
- Medical conditions that may condition or difficult the follow-up assessments.
- Older adults already included in regular physical exercise programmes will be excluded to participate in the hospital exercise cohort.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Complejo Hospitalario Universitario de Albacete
Albacete, Castille-La Mancha, 02006
Donostialdea, Osakidetza
Donostia / San Sebastian
Hospital Universitario de Getafe
Getafe
About this study
Official title: Development of Continuous Assessment of Muscle Quality and Frailty in Older Subjects Using Multi-parametric Combinations of Ultrasound and Blood Biomarkers: a Study Protocol for a Quasi-experimental Multi-center Study (ECOFRAIL Study)
We are conducting a study in different centers in Spain in elderly people, in order to assess the effectiveness of a physical exercise intervention program in people in a situation of frailty. Frailty in an elderly person is a situation in which, although there are no major differences in their usual abilities, the person presents a certain decrease in their capacities. This slight decrease is usually accompanied by a progressive deterioration.
Read the detailed description
Background: Frailty derived from muscle quality loss can potentially be delayed through early detection and physical exercise interventions. There is a need for affordable tools for the objective evaluation of muscle quality, in both cross-sectional and longitudinal assessment. Literature suggests that quantitative analysis of ultrasound data captures morphometric, compositional and microstructural muscle properties, while biological essays derived from blood samples are associated with functional information. The aim of this study is to evaluate multi-parametric combinations of ultrasound and blood-based biomarkers to provide a cross-sectional evaluation of the patient frailty phenotype and to monitor muscle quality changes associated with supervised exercise programs.
Methods: This is a prospective observational multi-center study including patients older than 70 years with ability to give informed consent. We will recruit 100 patients from hospital environments and 100 from primary care facilities. At least two exams per patient (baseline and follow-up), with a total of (with a minimum total of 400 exams) exams. In the hospital environments, 50 patients will be measured pre/post a 16-week individualized and supervised exercise programme, and 50 patients will be followed-up after the same period without intervention. The primary care patients will undergo a one-year follow-up evaluation. The primary goal is to compare cross-sectional evaluations of physical performance, functional capacity, body composition and derived scales of sarcopenia and frailty with biomarker combinations obtained from muscle ultrasound and blood-based essays. We will analyze ultrasound raw data obtained with a point-of-care device, and a set of biomarkers previously associated with frailty by quantitative Real time PCR (qRT-PCR) and enzyme-linked immunosorbent assay (ELISA). Secondly, we will analyze the sensitivity of these biomarkers to detect short-term muscle quality changes as well as functional improvement after a supervised exercise intervention with respect to usual care.
Discussion: The presented study protocol will combine portable technologies based on quantitative muscle ultrasound and blood biomarkers for objective cross-sectional assessment of muscle quality in both hospital and primary care settings. It aims to provide data to investigate associations between biomarker combinations with cross-sectional clinical assessment of frailty and sarcopenia, as well as musculoskeletal changes after multicomponent physical exercise programs.
- Conditions
- Frailty, Sarcopenia, Ultrasonography, Exercise
- Being tested
- Physical exercise
- Keywords
- Echography, Biomarkers, Diagnostic, Muscle, Exercise
- Medical subject headings
- Frailty, Sarcopenia, Motor Activity, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exerciseOther
- Hospital exercise cohort: Participants will be consecutively recruited from the scheduled patient list of the falls unit and the outpatient clinics of Hospital 1. After informed consent acquisition, patients will receive a baseline clinical evaluation. Ultrasound measurements and DXA scan will be conducted, and blood samples will be collected, processed, and stored. Patients will be included in the 16-week multicomponent physical exercise program described below. After the completion of the exercise program, at 16-week follow-up, clinical evaluation, ultrasound, DXA, and blood-sample testing will be repeated.
| Study group | Role | What they receive |
|---|---|---|
| Hospital control | No intervention | Hospital control cohort: Participants will be consecutively recruited from the scheduled patient list of the frailty unit, day hospital, and the outpatient clinic of the Geriatrics Department of Hospital 2. After obtaining informed consent, baseline study variables will be collected. Patients will be followed-up for a 16-week period, under usual care. After the follow-up period, baseline evaluation will be repeated. |
| Exercise | Experimental | Elderly people without muscle problems participating in the exercise program to see improvements in their muscle mass levels and quality Receives: Other: Physical exercise |
| Primary care Control | No intervention | Primary care cohort: Participants will be consecutively recruited from the scheduled patient list of the Primary Care Units. After informed consent acquisition, baseline study variables will be collected. Patients will be followed-up during one year, under usual care. After the one-year follow-up, the baseline evaluation will be repeated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker - Quality of Life - Muscle mass
Association between quantitative ultrasound biomarkers associated to muscle mass and quality and extracted from raw data and blood-based biomarkers and combinations thereof with clinical variables including frailty, sarcopenia, physical function, disability, nutritional status, body composition, and Quality of Life in three cohorts of older adults: hospital control cohort, hospital exercise cohort, and primary care cohort.
Muscle quality and mass: Ultrasound. Thickness (mm), cross-sectional area (cm²), perimeter (mm) and pennation angle (°). Frailty: FRAIL scale range 0-5. Frailty phenotype (0-5). Sarcopenia: SARC-F scale (0-10). Disability: GDS, 7 stages. Barthel index (0-100). Lawton and Brody index 0-8. Physical function: SPPB (0-12). IPAQ (0-3). Gait speed test, seconds. Grip strength, Jamar dynamometer, kilograms.
Quality of life: EQ 5D-5L, scale of 0-100.
Blood biomarkers: Vitamin D, Lutein zeaxanthin, Troponin T, Pro-BNP, and sRAGE with ELISA, miRNAs (qRT-PCR).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start1 Mar 2022
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
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 FrailtyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- three groups: control, exercise, and fragile
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Deusto
- Sponsor type
- University, hospital or other
- Collaborators
- Complejo Hospitalario Universitario de Albacete, Biogipuzkoa Health Research Institute, Hospital Universitario Getafe, European University of Vitoria-Gasteiz
- Responsible party
- Principal investigator, Xabier Rio de Frutos, University of Deusto
- Investigators
- Sergio Sanabria, Ph.D., Principal investigator, University of Deusto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294757
- Sponsor's protocol ID
- ECOFRAIL
- Acronym
- ECOFRAIL
- Status last verified
- Sep 2023
- First submitted
- 15 Mar 2022
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Virto N, Rio X, Angulo-Garay G, Garcia Molina R, Avendano Cespedes A, Cortes Zamora EB, Gomez Jimenez E, Alcantud Corcoles R, Rodriguez Manas L, Costa-Grille A, Matheu A, Marcos-Perez D, Lazcano U, Vergara I, Arjona L, Saeteros M, Lopez-de-Ipina D, Coca A, Abizanda Soler P, Sanabria SJ. Development of Continuous Assessment of Muscle Quality and Frailty in Older Patients Using Multiparametric Combinations of Ultrasound and Blood Biomarkers: Protocol for the ECOFRAIL Study. JMIR Res Protoc. 2024 Feb 23;13:e50325. doi: 10.2196/50325.
PubMed 38393761
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Continuous Assessment of Muscle Quality and Frailty in Older Subjects Using Multi-parametric Combinations of Ultrasound and Blood Biomarkers: a Study Protocol for a Quasi-experimental Multi-center Study (ECOFRAIL Study)
- ClinicalTrials.gov ID
- NCT05294757
- Acronym / sponsor ID
- ECOFRAIL / ECOFRAIL
- Conditions
- Frailty, Sarcopenia, Ultrasonography, Exercise
- Keywords
- Echography, Biomarkers, Diagnostic, Muscle, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of DeustoUniversity, hospital or other
- Collaborators
- Complejo Hospitalario Universitario de Albacete, Biogipuzkoa Health Research Institute, Hospital Universitario Getafe, European University of Vitoria-Gasteiz
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 24 Mar 2022 (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.
We are conducting a study in different centers in Spain in elderly people, in order to assess the effectiveness of a physical exercise intervention program in people in a situation of frailty. Frailty in an elderly person is a situation in which, although there are no major differences in their usual abilities, the person presents a certain decrease in their capacities. This slight decrease is usually accompanied by a progressive deterioration.
Detailed description
Background: Frailty derived from muscle quality loss can potentially be delayed through early detection and physical exercise interventions. There is a need for affordable tools for the objective evaluation of muscle quality, in both cross-sectional and longitudinal assessment. Literature suggests that quantitative analysis of ultrasound data captures morphometric, compositional and microstructural muscle properties, while biological essays derived from blood samples are associated with functional information. The aim of this study is to evaluate multi-parametric combinations of ultrasound and blood-based biomarkers to provide a cross-sectional evaluation of the patient frailty phenotype and to monitor muscle quality changes associated with supervised exercise programs.
Methods: This is a prospective observational multi-center study including patients older than 70 years with ability to give informed consent. We will recruit 100 patients from hospital environments and 100 from primary care facilities. At least two exams per patient (baseline and follow-up), with a total of (with a minimum total of 400 exams) exams. In the hospital environments, 50 patients will be measured pre/post a 16-week individualized and supervised exercise programme, and 50 patients will be followed-up after the same period without intervention. The primary care patients will undergo a one-year follow-up evaluation. The primary goal is to compare cross-sectional evaluations of physical performance, functional capacity, body composition and derived scales of sarcopenia and frailty with biomarker combinations obtained from muscle ultrasound and blood-based essays. We will analyze ultrasound raw data obtained with a point-of-care device, and a set of biomarkers previously associated with frailty by quantitative Real time PCR (qRT-PCR) and enzyme-linked immunosorbent assay (ELISA). Secondly, we will analyze the sensitivity of these biomarkers to detect short-term muscle quality changes as well as functional improvement after a supervised exercise intervention with respect to usual care.
Discussion: The presented study protocol will combine portable technologies based on quantitative muscle ultrasound and blood biomarkers for objective cross-sectional assessment of muscle quality in both hospital and primary care settings. It aims to provide data to investigate associations between biomarker combinations with cross-sectional clinical assessment of frailty and sarcopenia, as well as musculoskeletal changes after multicomponent physical exercise programs.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- three groups: control, exercise, and fragile
| Arm | Type | Receives |
|---|---|---|
| Hospital control | No intervention | –Hospital control cohort: Participants will be consecutively recruited from the scheduled patient list of the frailty unit, day hospital, and the outpatient clinic of the Geriatrics Department of Hospital 2. After obtaining informed consent, baseline study variables will be collected. Patients will be followed-up for a 16-week period, under usual care. After the follow-up period, baseline evaluation will be repeated. |
| Exercise | Experimental | Other: Physical exerciseElderly people without muscle problems participating in the exercise program to see improvements in their muscle mass levels and quality |
| Primary care Control | No intervention | –Primary care cohort: Participants will be consecutively recruited from the scheduled patient list of the Primary Care Units. After informed consent acquisition, baseline study variables will be collected. Patients will be followed-up during one year, under usual care. After the one-year follow-up, the baseline evaluation will be repeated. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age of at least 70 years old.
- Either gender.
- Ability to provide informed consent.
- Ability to perform all the functional tests.
- In the hospital exercise cohort, ability to perform the physical exercise program.
Key exclusion criteria (6 listed)
- Expected survival inferior to one year.
- Barthel scale < 70.
- Moderate to severe cognitive impairment.
- Refuse to participate.
- Medical conditions that may condition or difficult the follow-up assessments.
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 |
|---|---|---|
| Physical exercise1. Hospital exercise cohort: Participants will be consecutively recruited from the scheduled patient list of the falls unit and the outpatient clinics of Hospital 1. After informed consent acquisition, patients will receive a baseline clinical evaluation. Ultrasound measurements and DXA scan will be conducted, and blood samples will be collected, processed, and stored. Patients will be included in the 16-week multicomponent physical exercise program described below. After the completion of the exercise program, at 16-week follow-up, clinical evaluation, ultrasound, DXA, and blood-sample testing will be repeated. | Other | Exercise |
Primary outcome
Biomarker - Quality of Life - Muscle mass
Time frame: 2 years
Association between quantitative ultrasound biomarkers associated to muscle mass and quality and extracted from raw data and blood-based biomarkers and combinations thereof with clinical variables including frailty, sarcopenia, physical function, disability, nutritional status, body composition, and Quality of Life in three cohorts of older adults: hospital control cohort, hospital exercise cohort, and primary care cohort. Muscle quality and mass: Ultrasound. Thickness (mm), cross-sectional area (cm²), perimeter (mm) and pennation angle (°). Frailty: FRAIL scale range 0-5. Frailty phenotype (0-5). Sarcopenia: SARC-F scale (0-10). Disability: GDS, 7 stages. Barthel index (0-100). Lawton and Brody index 0-8. Physical function: SPPB (0-12). IPAQ (0-3). Gait speed test, seconds. Grip strength, Jamar dynamometer, kilograms. Quality of life: EQ 5D-5L, scale of 0-100. Blood biomarkers: Vitamin D, Lutein zeaxanthin, Troponin T, Pro-BNP, and sRAGE with ELISA, miRNAs (qRT-PCR).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Derived from this study: PubMed 38393761Virto N, Rio X, Angulo-Garay G, Garcia Molina R, Avendano Cespedes A, Cortes Zamora EB, Gomez Jimenez E, Alcantud Corcoles R, Rodriguez Manas L, Costa-Grille A, Matheu A, Marcos-Perez D, Lazcano U, Vergara I, Arjona L, Saeteros M, Lopez-de-Ipina D, Coca A, Abizanda Soler P, Sanabria SJ. Development of Continuous Assessment of Muscle Quality and Frailty in Older Patients Using Multiparametric Combinations of Ultrasound and Blood Biomarkers: Protocol for the ECOFRAIL Study. JMIR Res Protoc. 2024 Feb 23;13:e50325. doi: 10.2196/50325.
- Individual participant dataSharing planned: No
Related trials for Frailty
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Recruiting
Comparıson of the Effıcacy of Conventıonal Exercıse and Pılates ın Pre-fraıl and Fraıl Older Adults
Frailty Syndrome, Prefrail Elderly
Not yet recruiting
Adapting an Evidence-Based Physical Activity Intervention to Prevent Frailty and Functional Decline in Older Women Living With HIV
Mobility Impairment, Frailty
Recruiting
Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients
Mobility Limitation, Frailty
Not yet recruiting
Virtual Reality Multidomain Training for Older Adults With Cognitive Frailty
Cognitive Frailty
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.
Sergio Sanabria, Ph.D. principal investigator
University of Deusto
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise in people with Frailty and Sarcopenia, run by University of Deusto at 3 sites 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarker - Quality of Life - Muscle mass (time frame: 2 years). 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 NCT05294757, 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 4 May 2026.