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NCT03841669: eBACH

Exercise, Brain, and Cardiovascular Health

Completed NA Results posted Last updated 24 February 2025
What this trial tests

NA trial testing Aerobic Exercise Group in Cardiovascular Diseases in 130 participants. Completed in 15 February 2024.

Timeline
15 May 2019
Primary endpoint
3 February 2024
15 February 2024

Quick facts

Lead sponsorUniversity of Pittsburgh
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposebasic science
Enrollment130
Start date15 May 2019
Primary completion3 February 2024
Estimated completion15 February 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Pittsburgh

Who can join

Adults 26 to 58, any sex, with Cardiovascular Diseases. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Hippocampal Volume Primary · Baseline & 12 months

Magnetic Resonance Imaging (MRI) will be used to measure the structure of the brain. Segmentation algorithms applied to structural MRI images will be used to compute the volume of the hippocampus in particular, which will be evaluated for change over the course of the trial.

GroupValue95% CI
Aerobic Exercise Group-15.4-79.3 – 48.4
Physical Activity & Health Information Group-49.9-112.8 – 13
Change in Systolic Blood Pressure Responses to Behavioral Tasks Secondary · Baseline & 12 months

Average systolic blood pressure will be computed during a resting baseline period and during the performance of two behavioral tasks, (1) a Stroop color-word interference task and (2) a multi-source interference task. Mean baseline levels of systolic blood pressure will be subtracted from mean levels averaged across the two tasks to compute response scores, and changes in task-response scores will be evaluated over the course of the trial.

GroupValue95% CI
Aerobic Exercise Group-0.932-3.7 – 1.836
Physical Activity & Health Information Group-3.519-6.2 – -0.835
Change in Heart Rate Variability (HRV) Secondary · Baseline & 12 months

Heart rate variability will be computed from inter-beat intervals derived from electrocardiographic recordings while participants rest in the seated position. Average heart rate variability values from the recording period will be assessed for their change over the trial. Here, we report the natural log-transformed variance of high-frequency (HF) heart rate variability.

GroupValue95% CI
Aerobic Exercise Group0.0022-0.257 – 0.261
Physical Activity & Health Information Group-0.2035-0.472 – 0.065

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Aerobic Exercise Group
Serious: 1/64 (2%)
Deaths: 0/64
Physical Activity & Health Information Group
Serious: 0/66 (0%)
Deaths: 0/66

Serious adverse events (1 terms)

ReactionSystemAerobic Exercise GroupPhysical Activity & Health…
TumorSurgical and medical procedures
Other adverse events (2 terms — click to expand)

ReactionSystemAerobic Exercise GroupPhysical Activity & Health…
MusculoskeletalMusculoskeletal and connective tissue disorders
CardiovascularVascular disorders

Most-reported serious reactions: Tumor.

Data from ClinicalTrials.gov NCT03841669 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Effects of a laboratory-based aerobic exercise intervention on brain volume and cardiovascular health markers: protocol for a randomised clinical trial.
    Molina Hidalgo C, Collins AM, Crisafio ME, Grove G, et al · · 2023 · cited 4× · PMID 37968003 · DOI 10.1136/bmjopen-2023-077905
  2. Fitness and exercise effects on brain age: A randomized clinical trial.
    Wan L, Molina-Hidalgo C, Crisafio ME, Grove G, et al · · 2025 · cited 1× · PMID 40816637 · DOI 10.1016/j.jshs.2025.101079

Verify or expand the search:

Other trials of Aerobic Exercise Group

Trials testing the same drug.

Other recruiting trials for Cardiovascular Diseases

Currently open trials in the same condition.

Other University of Pittsburgh trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03841669.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing