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

Primary Purpose

Frailty, Sarcopenia, Ultrasonography

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Physical exercise
Sponsored by
University of Deusto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Frailty focused on measuring Echography, Biomarkers, Diagnostic, Muscle, Exercise

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Over 65 years old

Exclusion Criteria:

  • N/A

Sites / Locations

  • Complejo Hospitalario Universitario de AlbaceteRecruiting
  • Donostialdea, OsakidetzaRecruiting
  • Hospital Universitario de GetafeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

No Intervention

Arm Label

Hospital control

Exercise

Primary care Control

Arm Description

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.

Elderly people without muscle problems participating in the exercise program to see improvements in their muscle mass levels and quality

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
March 15, 2022
Last Updated
September 11, 2023
Sponsor
University of Deusto
Collaborators
Complejo Hospitalario Universitario de Albacete, Asociacion Instituto Biodonostia, Hospital Universitario Getafe, European University of Vitoria-Gasteiz
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1. Study Identification

Unique Protocol Identification Number
NCT05294757
Brief Title
Development of Continuous Assessment of Frailty and Muscle Quality in Older Subjects: ECOFRAIL Protocol
Acronym
ECOFRAIL
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Deusto
Collaborators
Complejo Hospitalario Universitario de Albacete, Asociacion Instituto Biodonostia, Hospital Universitario Getafe, European University of Vitoria-Gasteiz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty, Sarcopenia, Ultrasonography, Exercise
Keywords
Echography, Biomarkers, Diagnostic, Muscle, Exercise

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
three groups: control, exercise, and fragile
Masking
Participant
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hospital control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Exercise
Arm Type
Experimental
Arm Description
Elderly people without muscle problems participating in the exercise program to see improvements in their muscle mass levels and quality
Arm Title
Primary care Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Physical exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Biomarker - Quality of Life - Muscle mass
Description
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).
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xabier Río de Frutos, Ph.D.
Phone
+34 605754937
Email
xabier.rio@deusto.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergio Sanabria, Ph.D.
Organizational Affiliation
University of Deusto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Complejo Hospitalario Universitario de Albacete
City
Albacete
State/Province
Castilla La Mancha
ZIP/Postal Code
02006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedro Abizanda, MD, Ph.D.
Phone
+34967597651
First Name & Middle Initial & Last Name & Degree
Pedro Abizanza, MD, Ph.D.
Facility Name
Donostialdea, Osakidetza
City
Donostia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ander Matheu, Ph.D.
Facility Name
Hospital Universitario de Getafe
City
Getafe
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leocadio Rodríguez Mañas, MD, Ph.D

12. IPD Sharing Statement

Plan to Share IPD
No

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

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