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  • Effects of a laboratory-based aerobic exercise intervention on brain volume and cardiovascular health markers: protocol for a randomised clinical trial

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Cardiovascular medicine
Protocol
Effects of a laboratory-based aerobic exercise intervention on brain volume and cardiovascular health markers: protocol for a randomised clinical trial
  1. Cristina Molina Hidalgo1,2,
  2. Audrey M Collins1,2,
  3. Mary E Crisafio3,
  4. George Grove2,
  5. Thomas W Kamarck2,
  6. Chaeryon Kang4,
  7. Regina L Leckie2,
  8. Madison MacDonald2,
  9. Stephen B Manuck2,
  10. Anna L Marsland2,
  11. Matthew F Muldoon5,
  12. Javier Rasero6,
  13. Mark R Scudder2,
  14. Daniel Velazquez-Diaz1,2,6,
  15. Timothy Verstynen7,
  16. Lu Wan2,
  17. Peter J Gianaros2,
  18. Kirk I Erickson1,2,8
  1. 1AdventHealth Research Institute, Neuroscience Institute, Orlando, Florida, USA
  2. 2Department of Psychology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA
  3. 3College of Health and Human Sciences, Colorado State University, Fort Collins, Colorado, USA
  4. 4Department of Biostatistics, University of Pittsburgh, Pittsburgh, Pennsylvania, USA
  5. 5Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA
  6. 6ExPhy Research group and Department of Physical Education, Faculty of Education Sciences, University of Cadiz, Cadiz, Spain
  7. 7Department of Psychology, Carnegie Mellon University, Pittsburgh, Pennsylvania, USA
  8. 8PROFITH “PROmoting FITness and Health Through Physical Activity” Research Group, Sport and Health University Research Institute (iMUDS), Department of Physical and Sports Education, Faculty of Sport Sciences, University of Granada, Granada, Spain
  1. Correspondence to Dr Cristina Molina Hidalgo; cristina.molinahidalgo{at}adventhealth.com

Abstract

Introduction Physical activity (PA) has beneficial effects on brain health and cardiovascular disease (CVD) risk. Yet, we know little about whether PA-induced changes to physiological mediators of CVD risk influence brain health and whether benefits to brain health may also explain PA-induced improvements to CVD risk. This study combines neurobiological and peripheral physiological methods in the context of a randomised clinical trial to better understand the links between exercise, brain health and CVD risk.

Methods and analysis In this 12-month trial, 130 healthy individuals between the ages of 26 and 58 will be randomly assigned to either: (1) moderate-intensity aerobic PA for 150 min/week or (2) a health information control group. Cardiovascular, neuroimaging and PA measurements will occur for both groups before and after the intervention. Primary outcomes include changes in (1) brain structural areas (ie, hippocampal volume); (2) systolic blood pressure (SBP) responses to functional MRI cognitive stressor tasks and (3) heart rate variability. The main secondary outcomes include changes in (1) brain activity, resting state connectivity, cortical thickness and cortical volume; (2) daily life SBP stress reactivity; (3) negative and positive affect; (4) baroreflex sensitivity; (5) pulse wave velocity; (6) endothelial function and (7) daily life positive and negative affect. Our results are expected to have both mechanistic and public health implications regarding brain–body interactions in the context of cardiovascular health.

Ethics and dissemination Ethical approval has been obtained from the University of Pittsburgh Institutional Review Board (IRB ID: 19020218). This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule.

Trial registration number NCT03841669.

  • clinical physiology
  • preventive medicine
  • public health
  • magnetic resonance imaging
  • sports medicine
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2023-077905

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    Footnotes

    • Twitter @ccrismh

    • Contributors KIE and PJG conceived the study, designed the final study protocol, provided the domain knowledge expertise and are the PIs of the study; MEC, GG, TWK, RLL, MM, SBM, ALM, MFM, MRS, TV, LW helped in the design of the final study protocol, contributed to the technical design and revised the initial manuscript; CK and JR contributed to the technical design and provided biostatistical support; MEC, MM helped in the design of the study and coordinated ethics approval; CMH drafted the initial manuscript; AMC, DV-D, KIE revised the initial manuscript draft. All authors read and approved the final manuscript.

    • Funding This study is supported by a grant from the National Institutes of Health and the National Heart, Lung, and Blood Institute (P01 HL040962) awarded to PJG (PD) and KIE (Project PI).

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

    • Provenance and peer review Not commissioned; externally peer reviewed.