Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-29 @ 2:51 PM
Study NCT ID:
NCT03841669
Status:
COMPLETED
Last Update Posted:
2025-02-24
First Post:
2019-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Exercise, Brain, and Cardiovascular Health
Sponsor:
University of Pittsburgh
Organization:
Study Overview
Official Title:
Behavioral Studies of Cardiovascular Disease
Status:
COMPLETED
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
eBACH
Brief Summary:
eBACH is a randomized intervention to determine the effects of aerobic exercise on brain structure and function, as well as to determine how exercise-induced training effects relate to cardiovascular function via related brain changes.
Detailed Description:
Aim 1: To determine the neurobiology of exercise and cardiovascular factors: (1A) Body- to -Brain hypothesis: Exercise -induced changes in peripheral markers of cardiovascular health (e.g., cardiorespiratory fitness, peripheral vascular function) will precede and partly explain (statistically mediate) some of the exercise -induced changes in functional and structural features of areas defining visceral control circuits. (1B) Brain- to -Body hypothesis: Exercise -induced changes in functional and structural features of areas defining visceral control circuits precede and partly explain (statistically mediate) consequent changes in autonomic and neuroendocrine mediators of cardiovascular function that are under neural regulation, including baro-reflex sensitivity and heart rate variability. Aim 2: To determine the neurobiology of exercise self--reported correlates of cardiovascular function: (2A) Exercise will induce changes in visceral control areas engaged by functional magnetic resonance imaging (fMRI) tasks, and these changes will partly explain exercise- induced reductions in cardiovascular responsivity to challenges in daily life. (2B) Exercise will induce changes in visceral control areas engaged by an functional magnetic resonance imaging (fMRI) emotion processing and regulation paradigm, and these changes will partly explain exercise- induced improvements in affect measured in daily life by EMA and by conventional self- report instruments. The public health significance of this research is that it is designed to more precisely define and refine neurobiological targets to improve cardiovascular function and health.
Because of disruptions due to COVID-19, the study was placed into a compromised position that required conservation of funds and resources, resulting in a narrowing of focus and an abbreviated assessment protocol that limited the scale and scope of the longitudinal assessments and also reduced the sample size. As such, several of the secondary outcomes that were pre-specified were moved to "other pre-specified" during the course of the project.
Because of disruptions due to COVID-19, the study was placed into a compromised position that required conservation of funds and resources, resulting in a narrowing of focus and an abbreviated assessment protocol that limited the scale and scope of the longitudinal assessments and also reduced the sample size. As such, several of the secondary outcomes that were pre-specified were moved to "other pre-specified" during the course of the project.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P01HL040962 | NIH | None | https://reporter.nih.gov/quic… | View |