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CompletedNCT03834558SarcoImageUpdated Nov 3, 2020

Imaging Biomarkers of the Effects of a Mixed Exercise Program

An interventional study of Mixed exercise program in Sarcopenia, sponsored by University of Valencia. Completed at 1 site in Spain. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2020-11-03.

Sponsored by University of Valencia · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
70 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Sarcopenia

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Keywords

  • Sarcopenia
  • Frailty
  • Strength
  • myofascial self conditioning
  • image biomarkers
03

In context

Sarcopenia

1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.

This study's enrollment of 60 is close to the median of 60 across 775 interventional studies indexed under Sarcopenia.

Browse Sarcopenia studies →

Lead sponsor

University of Valencia is the lead sponsor of 349 studies on the registry; 73 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • No intervention
    Control Group

    They will follow their daily routine without added exercise

  • Experimental
    Intervention Group

    They will perform the mixed exercise program

    Other: Mixed exercise program

Interventions

  • OtherMixed exercise program

    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

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. Extramuscular subcutaneous 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 extramuscular subcutaneous fat (in ml)

    Time frame: 6 months

  5. 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

  6. 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

  7. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. Articular range

    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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

07

Study locations

1 site
  • University of Valencia - Faculty of Physiotherapy
    Valencia, 46009, Spain
08

References and documents

Publications

  • 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. PubMed 36070636 ↗

Individual participant data

Plan to share: No — No data will be shared with other researchers

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03834558
Lead sponsor
University of Valencia
Collaborators
Fundación Universidad Católica de Valencia San Vicente Mártir, Quironsalud
Responsible party
Francisco Martínez Arnau (Martínez-Arnau FM, PT, PhD, University of Valencia) — Principal investigator
First posted
Feb 8, 2019
Start date
Feb 6, 2019
Primary completion
Apr 15, 2020
Completion
Nov 2, 2020
Last update
Nov 3, 2020

Study contacts

Francisco Martinez Arnau, PhD
principal investigator · Universitat de Valencia
Roberto Sanz Requena, PhD
study director · Hospital QuironSalud - Hospital Universitario La Fe (GIBI)
Ana Pablos Monzó, PhD
study director · Fundación Universidad Católica de Valencia
Pilar Pérez-Ros, PhD
study director · Fundación Universidad Católica de Valencia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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