Clinical trial NCT03834558: Imaging Biomarkers of the Effects of a Mixed Exercise Program
Official title: SarcoImage: Anatomical and Physiological Validation by Magnetic Resonance Imaging Biomarkers of the Effects of High Intensity Strenght Training and Myofascial Self-conditioning on Sarcopenia in Frail and Prefrail Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Keywords: Sarcopenia
Frailty
Strength
myofascial self conditioning
image biomarkers
Lead sponsor: University of Valencia
Sponsor class: OTHER
Collaborators: name: Fundación Universidad Católica de Valencia San Vicente Mártir
name: Quironsalud
First posted: 2019-02-08
Enrollment: 60
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This project is based on an, longitudinal, prospective, controlled, randomized, intervention study and blind for the researchers responsible for the study. Thus, the subjects participating in the study will be divided into 2 groups, one of which will perform the mixed exercise program (intervention group, IG), and another that will follow their daily routine without added exercise (control group, CG).

Each group will have 2 measurements in which the corresponding variables will be evaluated: A) before the start of the intervention, B) at 6 months (at the end of the intervention)
Primary purpose: TREATMENT

Brief summary: The aim is quantify, correlate and establish the diagnostic and prognostic value of the variation of the image biomarkers obtained by magnetic resonance (muscle volume, morphological, biochemical and structural biomarkers) longitudinally in fragile or pre-frail elders with sarcopenia after a mixed physical training of strength and myofascial self-conditioning. This project is based on an, longitudinal, prospective, controlled, randomized, intervention study and blind for the researchers responsible for the study. 60 elderly with sarcopenia and frailty (Intervention Group, n=30; Control Group, n=30) will participate in the study. Intervention Group participants will perform 6-months mixed exercise program consisting in high-intensity strength training and self-myofascial conditioning. Data will be take trough 2 measurements that will be take place at baseline and post-intervention. Criteria of frailty, criteria of sarcopenia, sociodemographic, clinics, kinanthropometric, functional, nutritional and confusing variables will be evaluated. Moreover, magnetic resonance images will be performed to obtain muscle volume, morphological, biochemical and structural biomarkers.


Eligibility criteria: Inclusion Criteria:

* Patients of both genders,
* aged 70 years old or more,
* with habitual residence in Valencia,
* with independent wandering (they can have technical aids, but not from someone else)
* that meets Fried's pre-frailty or frailty criteria
* EGWSOP's sarcopenia criteria
* who has agreed to participate in the study and signed the informed consent

Exclusion Criteria:

* Patients with life expectancy less than six months
* Institutionalized patients
* Patients with severe visual or auditory deficits
* Patients with contraindication in the performance of physical exercise (cardiovascular risk factors)
* Patients with contraindications for the magnetic resonance study, especially carriers of non-compatible pacemakers, neurostimulators, cochlear implants and intracranial aneurysm clamping.
* Patients with severe psychiatric illness or moderate or severe cognitive impairment.
* Patients who refuse to sign the informed consent.

Primary outcomes:
measure: Muscle volume
timeFrame: 6 months
measure: Bone volume
timeFrame: 6 months
measure: Relative volume of intramuscular fat
timeFrame: 6 months
measure: Extramuscular subcutaneous fat
timeFrame: 6 months
measure: Microscopic fat fraction
timeFrame: 6 months
measure: Descriptors of muscle texture
timeFrame: 6 months
measure: Diffusion coefficient
timeFrame: 6 months
Secondary outcomes:
measure: Body muscle mass
timeFrame: 6 months
measure: Handgrip strength
timeFrame: 6 months
measure: Walking speed
timeFrame: 6 months
measure: Body mass index
timeFrame: 6 months
measure: Lean mass
timeFrame: 6 months
measure: Fat mass
timeFrame: 6 months
measure: Body perimeters
timeFrame: 6 months
measure: Articular range
timeFrame: 6 months
measure: Perceived pain
timeFrame: 6 months
measure: Activities of daily living
timeFrame: 6 months
measure: Functional and physical performance
timeFrame: 6 months
measure: Forced spirometry
timeFrame: 6 months
measure: Respiratory muscles strength
timeFrame: 6 months
measure: Perceived quality of life
timeFrame: 6 months
measure: Type of drugs used
timeFrame: 6 months
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: University of Valencia - Faculty of Physiotherapy
Study officials:
affiliation: Universitat de Valencia
name: Francisco Martinez Arnau, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital QuironSalud - Hospital Universitario La Fe (GIBI)
name: Roberto Sanz Requena, PhD
role: STUDY_DIRECTOR
affiliation: Fundación Universidad Católica de Valencia
name: Ana Pablos Monzó, PhD
role: STUDY_DIRECTOR
affiliation: Fundación Universidad Católica de Valencia
name: Pilar Pérez-Ros, PhD
role: STUDY_DIRECTOR
References:
citation: Flor-Rufino C, Barrachina-Igual J, Perez-Ros P, Pablos-Monzo A, Martinez-Arnau FM. Resistance training of peripheral muscles benefits respiratory parameters in older women with sarcopenia: Randomized controlled trial. Arch Gerontol Geriatr. 2023 Jan;104:104799. doi: 10.1016/j.archger.2022.104799. Epub 2022 Aug 29.