Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06507189
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-06-27
Brief Title:
Multidimensional Predictive Modeling to Understand Mechanisms of Exercise Response Heterogeneity in Older Adults M3AX
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Multidimensional Predictive Modeling to Understand Mechanisms of Exercise Response Heterogeneity in Older Adults
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
M3AX
Brief 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 adults capacity to attain the many health benefits of exercise
Detailed Description:
Aging-related functional declines are thought to be caused by hallmark biological processes1 that ultimately manifest in physical mental and metabolic impairments - compromising healthspan and quality of life QoL Exercise is a multipotent treatment with promise to mitigate most aging hallmarks but there is substantial variability in individual exercise responsiveness This inter-individual response heterogeneity IRH was first identified and extensively interrogated by Bouchard and colleagues in the context of endurance training ET Subsequently the investigators have demonstrated resistance training RT IRH and have studied potential IRH mechanisms The investigators then led multiple trials in older adults examining dose titration adjuvant nutrition or medication in attempts to lower poor response rates Many knowledge gaps remain as summarized in the National Institutes of Aging NIA workshop on IRH seeding this Requests for Applications RFA The investigators have assembled an interdisciplinary team to address the RFAs central goal to better understand factors underlying response variability to exercise training in older adults Although Health and Human Services HHS guidelines specify combined ET and RT to maximize health benefits in aging adults large-scale exercise trials studying IRH ie HERITAGE MoTrPAC have restricted participants to a single exercise mode For this project the investigators propose the innovative but logical strategy to use combined ET and RT Low cardiorespiratory fitness CRF VO2max and low functional muscle quality fMQ strengthmuscle mass are multi-system manifestations of the deterioration of the cellular hallmarks of aging Importantly both CRF and fMQ are modifiable with ET and RT Thus the investigators design premise is that combined ETRT is an excellent strategy for elucidating factors underlying IRH as it forges a path toward understanding and mitigating IRH in aging with direct translatability to best-evidence public health recommendations
It is yet to be determined how the hallmarks of aging interact to influence exercise responsiveness For example muscle mitochondrial energetics and proteostasis are inextricably linked and poor responder status may be caused by lack of energetic resources to maintain proteostasis throughout an exercise program Similarly aging disrupts circadian clocks leading to inflammation and disrupted cell signaling which may also contribute to IRH
While sources of IRH are a constellation of modifiable and non-modifiable factors the investigators will test the hypothesis that factors central to aging itself - aging hallmarks such as proteostasis mitochondrial energetics and inflammation as well as systemic and muscle-specific circadian clock function and output - are chief contributors to the multidimensional circuitry that determines whether an individual achieves the minimum clinically important difference MCID in CRF andor fMQ with exercise training The investigators will also test the hypothesis that altered exercise dosing coupled with lifestyle recommendations will promote attainment of MCIDs among older adults who do not initially respond With CRF and fMQ as primary clinical outcomes the investigators will use a 2-phase Sequential Multiple Assignment Randomized Trial SMART of combined ETRT with clinical phenotyping and bloodmuscle molecular and cellular analyses
It is yet to be determined how the hallmarks of aging interact to influence exercise responsiveness For example muscle mitochondrial energetics and proteostasis are inextricably linked and poor responder status may be caused by lack of energetic resources to maintain proteostasis throughout an exercise program Similarly aging disrupts circadian clocks leading to inflammation and disrupted cell signaling which may also contribute to IRH
While sources of IRH are a constellation of modifiable and non-modifiable factors the investigators will test the hypothesis that factors central to aging itself - aging hallmarks such as proteostasis mitochondrial energetics and inflammation as well as systemic and muscle-specific circadian clock function and output - are chief contributors to the multidimensional circuitry that determines whether an individual achieves the minimum clinically important difference MCID in CRF andor fMQ with exercise training The investigators will also test the hypothesis that altered exercise dosing coupled with lifestyle recommendations will promote attainment of MCIDs among older adults who do not initially respond With CRF and fMQ as primary clinical outcomes the investigators will use a 2-phase Sequential Multiple Assignment Randomized Trial SMART of combined ETRT with clinical phenotyping and bloodmuscle molecular and cellular analyses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None