Clinical trial NCT05294757: Development of Continuous Assessment of Frailty and Muscle Quality in Older Subjects: ECOFRAIL Protocol
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
Overall status: RECRUITING
Phase: NA
Conditions: Frailty
Sarcopenia
Ultrasonography
Exercise
Keywords: Echography
Biomarkers
Diagnostic
Muscle
Exercise
Lead sponsor: University of Deusto
Sponsor class: OTHER
Collaborators: name: Complejo Hospitalario Universitario de Albacete
name: Biogipuzkoa Health Research Institute
name: Hospital Universitario Getafe
name: European University of Vitoria-Gasteiz
First posted: 2022-03-24
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: three groups: control, exercise, and fragile
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

1. Age of at least 70 years old.
2. Either gender.
3. Ability to provide informed consent.
4. Ability to perform all the functional tests.
5. In the hospital exercise cohort, ability to perform the physical exercise program.

Exclusion Criteria:

1. Expected survival inferior to one year.
2. Barthel scale \< 70.
3. Moderate to severe cognitive impairment.
4. Refuse to participate.
5. Medical conditions that may condition or difficult the follow-up assessments.
6. Older adults already included in regular physical exercise programmes will be excluded to participate in the hospital exercise cohort.

Primary outcomes:
measure: Biomarker - Quality of Life - Muscle mass
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Albacete
country: Spain
facility: Complejo Hospitalario Universitario de Albacete
state: Castilla La Mancha
city: Donostia
country: Spain
facility: Donostialdea, Osakidetza
city: Getafe
country: Spain
facility: Hospital Universitario de Getafe
Study officials:
affiliation: University of Deusto
name: Sergio Sanabria, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: