Imaging Biomarkers of the Effects of a Mixed Exercise Program
- Conditions
- Sarcopenia
- Interventions
- Other: Mixed exercise program
- Registration Number
- NCT03834558
- Lead Sponsor
- University of Valencia
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Group Mixed exercise program They will perform the mixed exercise program
- Primary Outcome Measures
Name Time Method Bone volume 6 months 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 %)
Muscle volume 6 months 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)
Microscopic fat fraction 6 months 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 %)
Descriptors of muscle texture 6 months 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)
Diffusion coefficient 6 months 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)
Relative volume of intramuscular fat 6 months 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 %)
Extramuscular subcutaneous fat 6 months 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 extramuscular subcutaneous fat (in ml)
- Secondary Outcome Measures
Name Time Method Body muscle mass 6 months 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.
Handgrip strength 6 months 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.
Walking speed 6 months 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.
Fat mass 6 months Changes on fat impedance (measured in % by bioimpedance) generated by 6-month program of high intensity training and myofascial self-conditioning
Articular range 6 months 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
Perceived quality of life 6 months 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)
Type of drugs used 6 months Type and dose of drugs consumed before and after a 6-month program of high intensity training and myofascial self-conditioning
Body mass index 6 months Changes on body mass index (measured in kg/m2) generated by 6-month program of high intensity training and myofascial self-conditioning
Lean mass 6 months Changes on lean impedance (measured in % by bioimpedance) generated by 6-month program of high intensity training and myofascial self-conditioning
Body perimeters 6 months Changes on calf and thigh perimeter (measured in cm) generated by 6-month program of high intensity training and myofascial self-conditioning
Perceived pain 6 months 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
Activities of daily living 6 months 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
Functional and physical performance 6 months 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
Forced spirometry 6 months 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
Respiratory muscles strength 6 months 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
Trial Locations
- Locations (1)
University of Valencia - Faculty of Physiotherapy
🇪🇸Valencia, Spain