Muscle Multi-parametric NMR Imaging Development in Aged People With Sarcopenia or Frailty Syndrom… (NCT04238494) | Clinical Trial Compass
UnknownNot Applicable
Muscle Multi-parametric NMR Imaging Development in Aged People With Sarcopenia or Frailty Syndrome; CLINical Study
France60 participantsStarted 2019-10-18
Plain-language summary
Frailty is a multideterminant syndrome in which muscle function appears to play a central role. Muscle function depends on brain control, nutrition and perfusion. We hypothesized that multiparametric MRI assessment combined with comprehensive gerontological assessment (CGA) and routine biological assessment of inflammation in a sample of older people with and without diabetes will allow to explore on one side the possibilities of multi-parametric MRI muscle and brain imaging to describe the correlates of frailty and on the other side will describe the different muscle/brain alterations due to diabetes in frailty.
The main objective is to compare the lipid percent of the rectus femoris in frail and pre-frail older subjects and in non-frail older subjects.
Who can participate
Age range
70 Years – 90 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:
* Robust or frail or pre-frail with at least 25% frail and 25% pre-frail according to Frieds criteria
* Barthel index \> or = 60/100
* With or without diabetes mellitus, 45 to 55 % with known diabetes mellitus
* With no contraindication to undergo an MRI examination
Exclusion Criteria:
* not willing to participate
* not able to give informed consent or to understand basic instruction due to any problem (sensorial, educational, language)
* without social insurance
* with a legal protection
* with significant cognitive alteration (MMSe\<21/30 or in case of low literacy \<19/30)
* with a recent (2 month period) severe event: hospitalization, sepsis, stroke even with complete recovery, trauma
* with stroke sequelae (motor, speech)
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?
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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.