Imaging Biomarkers of the Effects of a Mixed Exercise Program (SarcoImage)

U

University of Valencia

Status

Completed

Conditions

Sarcopenia

Treatments

Other: Mixed exercise program

Study type

Interventional

Funder types

Other

Identifiers

NCT03834558
H1488746567568

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups

Control Group
No Intervention group
Description:
They will follow their daily routine without added exercise
Intervention Group
Experimental group
Description:
They will perform the mixed exercise program
Treatment:
Other: Mixed exercise program

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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