Imaging Biomarkers of the Effects of a Mixed Exercise Program

University of Valencia60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Sarcopenia

Interventions

Mixed exercise programOTHER

A progressive program of high intensity strength and myofascial conditioning will be carried out in 2 non-consecutive weekly sessions (24 weeks). Each session will include: A) Warm up on a cycle ergometer B) Strength circuit: 6 exercises will be included to strengthen different muscle groups (2 in the upper extremities, 2 in the trunk and 2 in the lower extremities). 3 sets of 10-15 repetitions until the failure. The load will be set to 70% of 1 maximal resistance. C) Self-myofascial conditioning: 10 repetitions, in the direction of the fibres of each muscle group, with different materials. 7 muscle groups will be worked (quadriceps, hamstrings, abductors, gluteus, pectoralis, full back and trapezius). D) At the end, static stretches will be performed

Eligibility

Sex: ALLMin age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Valencia - Faculty of Physiotherapy

Valencia, Spain

Outcomes

Primary Outcomes

Muscle volume

Changes related to macroscopic changes in muscle tissue assessed by magnetic resonance after a 6-month program of high intensity training and myofascial self-conditioning, specifically muscle volume of the thigh by compartment - anterior, medial and posterior (in ml)

Time frame: 6 months

Bone volume

Changes related to macroscopic changes in bone tissue assessed by magnetic resonance after a 6-month program of high intensity training and myofascial self-conditioning, specifically relative volume of bone (in %)

Time frame: 6 months

Relative volume of intramuscular fat

Changes related to macroscopic changes in fat tissue assessed by magnetic resonance after a 6-month program of high intensity training and myofascial self-conditioning, specifically relative volume of intramuscular fat (in %)

Time frame: 6 months

Extramuscular subcutaneous fat

Time frame: 6 months

Microscopic fat fraction

Changes related to microscopic changes in fat tissue assessed by magnetic resonance after a 6-month program of high intensity training and myofascial self-conditioning, specifically microscopic fat fraction (in %)

Time frame: 6 months

Descriptors of muscle texture

Changes related to microscopic changes in muscle tissue assessed by magnetic resonance after a 6-month program of high intensity training and myofascial self-conditioning, specifically statistical descriptors of muscle texture: energy, entropy, contrast and homogeneity (adimensional)

Time frame: 6 months

Diffusion coefficient

Changes related to microscopic changes in diffusion coefficient assessed by magnetic resonance after a 6-month program of high intensity training and myofascial self-conditioning, specifically diffusion coefficient and apparent diffusion coefficient (mm2/s)

Time frame: 6 months

Secondary Outcomes

Body muscle mass

Changes produced by 6-month program of high intensity training and myofascial self-conditioning on body muscle mass (kg/m2) measured according to criteria of sarcopenia of European Working Group of Sarcopenia in Older People.

Time frame: 6 months

Handgrip strength

Changes produced by 6-month program of high intensity training and myofascial self-conditioning on handgrip strength (kg) measured according to criteria of sarcopenia of European Working Group of Sarcopenia in Older People.

Time frame: 6 months

Walking speed

Changes produced by 6-month program of high intensity training and myofascial self-conditioning on walking speed (m/s) measured according to criteria of sarcopenia of European Working Group of Sarcopenia in Older People.

Time frame: 6 months

Body mass index

Changes on body mass index (measured in kg/m2) generated by 6-month program of high intensity training and myofascial self-conditioning

Time frame: 6 months

Lean mass

Changes on lean impedance (measured in % by bioimpedance) generated by 6-month program of high intensity training and myofascial self-conditioning

Time frame: 6 months

Fat mass

Changes on fat impedance (measured in % by bioimpedance) generated by 6-month program of high intensity training and myofascial self-conditioning

Time frame: 6 months

Body perimeters

Changes on calf and thigh perimeter (measured in cm) generated by 6-month program of high intensity training and myofascial self-conditioning

Time frame: 6 months

Articular range

Data from ClinicalTrials.gov

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Changes on range of joint movement of coxofemoral and knee articulation (measured in degrees) generated by 6-month program of high intensity training and myofascial self-conditioning

Time frame: 6 months

Perceived pain

Changes on pain (measured by visual analogic scale, 0 to 10 points, higher values = worse outcome) generated by 6-month program of high intensity training and myofascial self-conditioning

Time frame: 6 months

Activities of daily living

Changes in functionality and independence measured by Barthel Index (0 to 100 points, \< 60 dependence, higher values = better outcome) produced by 6-month program of high intensity training and myofascial self-conditioning

Time frame: 6 months

Functional and physical performance

Changes in functional and physical performance measured by Short Physical Performance Battery (0 to 12 points, higher score = higher function) produced by 6-month program of high intensity training and myofascial self-conditioning

Time frame: 6 months

Forced spirometry

Changes in respiratory function, measured by forced spirometry parameters assessed with a spirometer, produced by 6-month program of high intensity training and myofascial self-conditioning

Time frame: 6 months

Respiratory muscles strength

Changes in respiratory pressures generated in mouth by respiratory muscles (assessed with a respiratory pressure gauge) produced by 6-month program of high intensity training and myofascial self-conditioning

Time frame: 6 months

Perceived quality of life

Changes produced by 6-month program of high intensity training and myofascial self-conditioning related to quality of life (EuroQol 5 Dimensions - 3 levels Index, 0 to 1 points, higher values = better outcome)

Time frame: 6 months

Type of drugs used

Type and dose of drugs consumed before and after a 6-month program of high intensity training and myofascial self-conditioning

Time frame: 6 months