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Completed

NCT Number: NCT03834558

Imaging Biomarkers of the Effects of a Mixed Exercise Program

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.

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Key information

Conditions

Sarcopenia Atrophy Frailty Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Valencia - Faculty of Physiotherapy

Valencia, 46009, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mixed exercise program

Other

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

Primary outcomes

  1. Muscle volume

    Time frame: 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)

  2. Bone volume

    Time frame: 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 %)

  3. Relative volume of intramuscular fat

    Time frame: 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 %)

  4. Extramuscular subcutaneous fat

    Time frame: 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)

  5. Microscopic fat fraction

    Time frame: 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 %)

  6. Descriptors of muscle texture

    Time frame: 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)

  7. Diffusion coefficient

    Time frame: 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)

Secondary outcomes

  1. Body muscle mass

    Time frame: 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.

  2. Handgrip strength

    Time frame: 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.

  3. Walking speed

    Time frame: 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.

  4. Body mass index

    Time frame: 6 months

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

  5. Lean mass

    Time frame: 6 months

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

  6. Fat mass

    Time frame: 6 months

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

  7. Body perimeters

    Time frame: 6 months

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

  8. Articular range

    Time frame: 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

  9. Perceived pain

    Time frame: 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

  10. Activities of daily living

    Time frame: 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

  11. Functional and physical performance

    Time frame: 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

  12. Forced spirometry

    Time frame: 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

  13. Respiratory muscles strength

    Time frame: 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

  14. Perceived quality of life

    Time frame: 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)

  15. Type of drugs used

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Collaborators

  • Fundación Universidad Católica de Valencia San Vicente Mártir
  • Quironsalud

Registry information

Official study 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

Acronym: SarcoImage

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 8, 2019
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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