CompletedNot Applicable

Imaging Biomarkers of the Effects of a Mixed Exercise Program

Spain60 participantsStarted 2019-02-06

Plain-language 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.

Who can participate

Age range

70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Muscle volume

Timeframe: 6 months

Bone volume

Timeframe: 6 months

Relative volume of intramuscular fat

Timeframe: 6 months

Extramuscular subcutaneous fat

Timeframe: 6 months

Microscopic fat fraction

Timeframe: 6 months

Descriptors of muscle texture

Timeframe: 6 months

Diffusion coefficient

Timeframe: 6 months

Trial details

NCT IDNCT03834558

SponsorUniversity of Valencia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-04-15

View on ClinicalTrials.gov More Sarcopenia trials

Plain-language summary

Who can participate

Age range

70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Muscle volume

Timeframe: 6 months

Bone volume

Timeframe: 6 months

Relative volume of intramuscular fat

Timeframe: 6 months

Extramuscular subcutaneous fat

Timeframe: 6 months

Microscopic fat fraction

Timeframe: 6 months

Descriptors of muscle texture

Timeframe: 6 months

Diffusion coefficient

Timeframe: 6 months