Multidimensional Predictive Modeling to Understand Mechanisms of Exercise Response Heterogeneity … (NCT06507189) | Clinical Trial Compass
RecruitingNot Applicable
Multidimensional Predictive Modeling to Understand Mechanisms of Exercise Response Heterogeneity in Older Adults (M3AX)
United States250 participantsStarted 2025-01-27
Plain-language summary
Aging-related functional declines are thought to be caused by hallmark biological processes that ultimately manifest in physical, mental, and metabolic impairments that compromise healthspan and quality of life. Exercise is a multipotent treatment with promise to mitigate most aging hallmarks, but there is substantial variability in exercisƒe responsiveness. Combining endurance and resistance training in alignment with public health guidelines will be used to better understand variable exercise responsiveness in older adults with the ultimate goal of improving each older adult's capacity to attain the many health benefits of exercise.
Who can participate
Age range
60 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
. Male or female aged 60 or above
. Free of chronic disease
. No structured exercise program (2 or more bouts/wk) within previous 12 months
. Cognitively capable of providing informed consent
Exclusion criteria
. Neuromuscular or musculoskeletal disorder that would limit ability to perform the exercise and/or testing bouts
. Cardiopulmonary disorders or reduced breathing capacity
. Metabolic diseases including markers of liver disease (ALT \> 52 U/l) and type 2 diabetes (HbA1C = or \> 6.5, fasting blood glucose = or \> 126 mg/dl)
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
1
Cardiorespiratory fitness (CRF)
Timeframe: 23 weeks
2
Functional muscle quality (fMQ)
Timeframe: 23 weeks
Trial details
NCT IDNCT06507189
SponsorFlorida Institute for Human and Machine Cognition
. Any other disease or disorder that would influence exercise response (e.g., chronic kidney disease, dementia, current cancer diagnosis or within 2 yr remission, cerebrovascular disease)
. Any current infectious disease
. Life expectancy \< 1 year
. Insulin sensitizing/blood glucose lowering agents such as metformin or metabolic weight loss agents (e.g. GLP-1 agonists)
. High dose statin (dose equivalent of 40 mg/d or higher simvastatin)