Development of Continuous Assessment of Frailty and Muscle Quality in Older Subjects: ECOFRAIL Protocol

NCT05294757 | Completed DMC

• 1 other identifier: ECOFRAIL
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Frailty; Sarcopenia; Ultrasonography; Exercise

Keywords

Echography; Biomarkers; Diagnostic; Muscle; Exercise

Outcome Measures

Primary Outcomes (1)

• 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).

  2 years

Study Arms (3)

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

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.

Interventions

Physical exercise OTHER

1\. 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.

Exercise

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• European University of Vitoria-Gasteiz: collaborator
• Hospital Universitario Getafe: collaborator
• Biogipuzkoa Health Research Institute: collaborator
• University of Deusto: lead
• Complejo Hospitalario Universitario de Albacete: collaborator

Study Sites (3)

Complejo Hospitalario Universitario de Albacete

Albacete, Castille-La Mancha, 02006, Spain

Location

Donostialdea, Osakidetza

Donostia / San Sebastian, Spain

Location

Hospital Universitario de Getafe

Getafe, Spain

Location

Related Publications (1)

• 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.

  PMID: 38393761 DERIVED

MeSH Terms

Conditions

Frailty; Sarcopenia; Motor Activity; Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sergio Sanabria, Ph.D.

  University of Deusto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher HealthPASS team

Model Details: three groups: control, exercise, and fragile

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: March 24, 2022
• Study Start: March 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: May 4, 2026

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)