Study Summary
This trial is designed to investigate the effect of different types of exercise on the neurocognitive functioning of sedentary older adults with and without cardiovascular risk factors.
- Aging
- Cardiovascular Risk
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
4 Primary · 9 Secondary · Reporting Duration: Baseline and post-intervention at 12 months
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
3 Treatment Groups
Active control intervention
1 of 3
Multidomain intervention
1 of 3
Physical exercise intervention
1 of 3
Active Control
Experimental Treatment
318 Total Participants · 3 Treatment Groups
Primary Treatment: Aerobic and resistance exercises · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Baker, Laura D., Laura L. Frank, Karen Foster-Schubert, Pattie S Green, Charles W. Wilkinson, Anne McTiernan, Brenna A. Cholerton, et al.. 2010. “Aerobic Exercise Improves Cognition for Older Adults with Glucose Intolerance, A Risk Factor for Alzheimer's Disease”. Journal of Alzheimer's Disease. IOS Press. doi:10.3233/jad-2010-100768.
- Colcombe, Stanley, and Arthur F. Kramer. 2003. “Fitness Effects on the Cognitive Function of Older Adults”. Psychological Science. SAGE Publications. doi:10.1111/1467-9280.t01-1-01430.
- Bherer, Louis, Arthur F. Kramer, Matthew S. Peterson, Stanley Colcombe, Kirk Erickson, and Ensar Becic. 2005. “Training Effects on Dual-task Performance: Are There Age-related Differences in Plasticity of Attentional Control?”. Psychology and Aging. American Psychological Association (APA). doi:10.1037/0882-7974.20.4.695.
- Friedman, Joseph I., Cheuk Y. Tang, Hans J. de Haas, Lisa Changchien, Georg Goliasch, Puneet Dabas, Victoria Wang, Zahi A. Fayad, Valentin Fuster, and Jagat Narula. 2014. “Brain Imaging Changes Associated with Risk Factors for Cardiovascular and Cerebrovascular Disease in Asymptomatic Patients”. JACC: Cardiovascular Imaging. Elsevier BV. doi:10.1016/j.jcmg.2014.06.014.
- Jennings, J. R., M. F. Muldoon, C. Ryan, J. C. Price, P. Greer, K. Sutton-Tyrrell, F. M. van der Veen, and C. C. Meltzer. 2005. “Reduced Cerebral Blood Flow Response and Compensation Among Patients with Untreated Hypertension”. Neurology. Ovid Technologies (Wolters Kluwer Health). doi:10.1212/01.wnl.0000158283.28251.3c.
- Vianna, Lauro C., Shekhar H. Deo, Areum K. Jensen, Seth W. Holwerda, Matthew C. Zimmerman, and Paul J. Fadel. 2015. “Impaired Dynamic Cerebral Autoregulation at Rest and During Isometric Exercise in Type 2 Diabetes Patients”. American Journal of Physiology-heart and Circulatory Physiology. American Physiological Society. doi:10.1152/ajpheart.00343.2014.
- Wang, R., L. Fratiglioni, A. Laveskog, G. Kalpouzos, C.-H. Ehrenkrona, Y. Zhang, L. Bronge, L.-O. Wahlund, L. Bäckman, and C. Qiu. 2013. “Do Cardiovascular Risk Factors Explain the Link Between White Matter Hyperintensities and Brain Volumes in Old Age? A Population-based Study”. European Journal of Neurology. Wiley. doi:10.1111/ene.12319.
- Arntzen, K. A., H. Schirmer, T. Wilsgaard, and E. B. Mathiesen. 2010. “Impact of Cardiovascular Risk Factors on Cognitive Function: The Tromsø Study”. European Journal of Neurology. Wiley. doi:10.1111/j.1468-1331.2010.03263.x.
- Dregan, Alex, Robert Stewart, and Martin C. Gulliford. 2012. “Cardiovascular Risk Factors and Cognitive Decline in Adults Aged 50 and Over: A Population-based Cohort Study”. Age and Ageing. Oxford University Press (OUP). doi:10.1093/ageing/afs166.
- Eskelinen, Marjo H., Tiia Ngandu, Eeva‐Liisa Helkala, Jaakko Tuomilehto, Aulikki Nissinen, Hilkka Soininen, and Miia Kivipelto. 2008. “Fat Intake at Midlife and Cognitive Impairment Later in Life: A Population‐based CAIDE Study”. International Journal of Geriatric Psychiatry. Wiley. doi:10.1002/gps.1969.
- Köbe, Theresa, A.Veronica Witte, Ariane Schnelle, Anne Lesemann, Sonja Fabian, Valentina A. Tesky, Johannes Pantel, and Agnes Flöel. 2016. “Combined Omega-3 Fatty Acids, Aerobic Exercise and Cognitive Stimulation Prevents Decline in Gray Matter Volume of the Frontal, Parietal and Cingulate Cortex in Patients with Mild Cognitive Impairment”. Neuroimage. Elsevier BV. doi:10.1016/j.neuroimage.2015.09.050.
- van den Berg, Esther, Raoul P. Kloppenborg, Roy P.C. Kessels, L. Jaap Kappelle, and Geert Jan Biessels. 2009. “Type 2 Diabetes Mellitus, Hypertension, Dyslipidemia and Obesity: A Systematic Comparison of Their Impact on Cognition”. Biochimica Et Biophysica Acta (BBA) - Molecular Basis of Disease. Elsevier BV. doi:10.1016/j.bbadis.2008.09.004.
- Ngandu, Tiia, Jenni Lehtisalo, Alina Solomon, Esko Levälahti, Satu Ahtiluoto, Riitta Antikainen, Lars Bäckman, et al.. 2015. “A 2 Year Multidomain Intervention of Diet, Exercise, Cognitive Training, and Vascular Risk Monitoring Versus Control to Prevent Cognitive Decline in At-risk Elderly People (FINGER): A Randomised Controlled Trial”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(15)60461-5.
- Lussier, Maxime, Christine Gagnon, and Louis Bherer. 2012. “An Investigation of Response and Stimulus Modality Transfer Effects After Dual-task Training in Younger and Older”. Frontiers in Human Neuroscience. Frontiers Media SA. doi:10.3389/fnhum.2012.00129.
- Karssemeijer, E.G.A. (Esther), J.A. (Justine) Aaronson, W.J. (Willem) Bossers, T. (Tara) Smits, M.G.M. (Marcel) Olde Rikkert, and R.P.C. (Roy) Kessels. 2017. “Positive Effects of Combined Cognitive and Physical Exercise Training on Cognitive Function in Older Adults with Mild Cognitive Impairment or Dementia: A Meta-analysis”. Ageing Research Reviews. Elsevier BV. doi:10.1016/j.arr.2017.09.003.
- Lupien, S.J., F. Maheu, M. Tu, A. Fiocco, and T.E. Schramek. 2007. “The Effects of Stress and Stress Hormones on Human Cognition: Implications for the Field of Brain and Cognition”. Brain and Cognition. Elsevier BV. doi:10.1016/j.bandc.2007.02.007.
- DeRight, Jonathan, Randall S. Jorgensen, and Misaell J. Cabral. 2015. “Composite Cardiovascular Risk Scores and Neuropsychological Functioning: A Meta-analytic Review”. Annals of Behavioral Medicine. Oxford University Press (OUP). doi:10.1007/s12160-014-9681-0.
- Stampfer, Meir J., Frank B. Hu, JoAnn E. Manson, Eric B. Rimm, and Walter C. Willett. 2000. “Primary Prevention of Coronary Heart Disease in Women Through Diet and Lifestyle”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejm200007063430103.
- Erickson, K. I., S. J. Colcombe, R. Wadhwa, L. Bherer, M. S. Peterson, P. E. Scalf, J. S. Kim, M. Alvarado, and A. F. Kramer. 2006. “Training-induced Functional Activation Changes in Dual-task Processing: An Fmri Study”. Cerebral Cortex. Oxford University Press (OUP). doi:10.1093/cercor/bhj137.
- Hodyl, Nicolette A., Luke Schneider, Ann-Maree Vallence, Angela Clow, Michael C. Ridding, and Julia B. Pitcher. 2016. “The Cortisol Awakening Response Is Associated with Performance of a Serial Sequence Reaction Time Task”. International Journal of Psychophysiology. Elsevier BV. doi:10.1016/j.ijpsycho.2015.12.007.
- Launer, Lenore J., Cora E. Lewis, Pamela J. Schreiner, Steve Sidney, Harsha Battapady, David R. Jacobs, Kelvin O. Lim, et al.. 2015. “Vascular Factors and Multiple Measures of Early Brain Health: CARDIA Brain MRI Study”. Edited by Mohammad Arfan Ikram. Plos One. Public Library of Science (PLoS). doi:10.1371/journal.pone.0122138.
- Yamamoto, Naomune, Gaku Yamanaka, Emiko Takasugi, Motonao Ishikawa, Takashi Yamanaka, Shougo Murakami, Toshiaki Hanafusa, Kozo Matsubayashi, and Kuniaki Otsuka. 2009. “Lifestyle Intervention Reversed Cognitive Function in Aged People with Diabetes Mellitus: Two-year Follow up”. Diabetes Research and Clinical Practice. Elsevier BV. doi:10.1016/j.diabres.2009.05.014.
- Zhu, Xinyi, Shufei Yin, Minjia Lang, Rongqiao He, and Juan Li. 2016. “The More the Better? A Meta-analysis on Effects of Combined Cognitive and Physical Intervention on Cognition in Healthy Older Adults”. Ageing Research Reviews. Elsevier BV. doi:10.1016/j.arr.2016.07.003.
- Köbe, Theresa, A.Veronica Witte, Ariane Schnelle, Anne Lesemann, Sonja Fabian, Valentina A. Tesky, Johannes Pantel, and Agnes Flöel. 2016. “Combined Omega-3 Fatty Acids, Aerobic Exercise and Cognitive Stimulation Prevents Decline in Gray Matter Volume of the Frontal, Parietal and Cingulate Cortex in Patients with Mild Cognitive Impairment”. Neuroimage. Elsevier BV. doi:10.1016/j.neuroimage.2015.09.050.
- Ngandu, Tiia, Jenni Lehtisalo, Alina Solomon, Esko Levälahti, Satu Ahtiluoto, Riitta Antikainen, Lars Bäckman, et al.. 2015. “A 2 Year Multidomain Intervention of Diet, Exercise, Cognitive Training, and Vascular Risk Monitoring Versus Control to Prevent Cognitive Decline in At-risk Elderly People (FINGER): A Randomised Controlled Trial”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(15)60461-5.
- Friedman JI, Tang CY, de Haas HJ, Changchien L, Goliasch G, Dabas P, Wang V, Fayad ZA, Fuster V, Narula J. Brain imaging changes associated with risk factors for cardiovascular and cerebrovascular disease in asymptomatic patients. JACC Cardiovasc Imaging. 2014 Oct;7(10):1039-53. doi: 10.1016/j.jcmg.2014.06.014.
- DeRight J, Jorgensen RS, Cabral MJ. Composite cardiovascular risk scores and neuropsychological functioning: a meta-analytic review. Ann Behav Med. 2015 Jun;49(3):344-57. doi: 10.1007/s12160-014-9681-0.
- Wang R, Fratiglioni L, Laveskog A, Kalpouzos G, Ehrenkrona CH, Zhang Y, Bronge L, Wahlund LO, Backman L, Qiu C. Do cardiovascular risk factors explain the link between white matter hyperintensities and brain volumes in old age? A population-based study. Eur J Neurol. 2014 Aug;21(8):1076-1082. doi: 10.1111/ene.12319. Epub 2013 Dec 7.
- Arntzen KA, Schirmer H, Wilsgaard T, Mathiesen EB. Impact of cardiovascular risk factors on cognitive function: the Tromso study. Eur J Neurol. 2011 May;18(5):737-43. doi: 10.1111/j.1468-1331.2010.03263.x. Epub 2010 Dec 8.
- Stampfer MJ, Hu FB, Manson JE, Rimm EB, Willett WC. Primary prevention of coronary heart disease in women through diet and lifestyle. N Engl J Med. 2000 Jul 6;343(1):16-22. doi: 10.1056/NEJM200007063430103.
- Bherer L, Kramer AF, Peterson MS, Colcombe S, Erickson K, Becic E. Training effects on dual-task performance: are there age-related differences in plasticity of attentional control? Psychol Aging. 2005 Dec;20(4):695-709. doi: 10.1037/0882-7974.20.4.695.
- Zhu X, Yin S, Lang M, He R, Li J. The more the better? A meta-analysis on effects of combined cognitive and physical intervention on cognition in healthy older adults. Ageing Res Rev. 2016 Nov;31:67-79. doi: 10.1016/j.arr.2016.07.003. Epub 2016 Jul 14.
- Karssemeijer EGA, Aaronson JA, Bossers WJ, Smits T, Olde Rikkert MGM, Kessels RPC. Positive effects of combined cognitive and physical exercise training on cognitive function in older adults with mild cognitive impairment or dementia: A meta-analysis. Ageing Res Rev. 2017 Nov;40:75-83. doi: 10.1016/j.arr.2017.09.003. Epub 2017 Sep 12.
- Lupien SJ, Maheu F, Tu M, Fiocco A, Schramek TE. The effects of stress and stress hormones on human cognition: Implications for the field of brain and cognition. Brain Cogn. 2007 Dec;65(3):209-37. doi: 10.1016/j.bandc.2007.02.007. Epub 2007 Apr 26.
- van den Berg E, Kloppenborg RP, Kessels RP, Kappelle LJ, Biessels GJ. Type 2 diabetes mellitus, hypertension, dyslipidemia and obesity: A systematic comparison of their impact on cognition. Biochim Biophys Acta. 2009 May;1792(5):470-81. doi: 10.1016/j.bbadis.2008.09.004. Epub 2008 Sep 23.
- Kobe T, Witte AV, Schnelle A, Lesemann A, Fabian S, Tesky VA, Pantel J, Floel A. Combined omega-3 fatty acids, aerobic exercise and cognitive stimulation prevents decline in gray matter volume of the frontal, parietal and cingulate cortex in patients with mild cognitive impairment. Neuroimage. 2016 May 1;131:226-38. doi: 10.1016/j.neuroimage.2015.09.050. Epub 2015 Oct 1.
- Colcombe S, Kramer AF. Fitness effects on the cognitive function of older adults: a meta-analytic study. Psychol Sci. 2003 Mar;14(2):125-30. doi: 10.1111/1467-9280.t01-1-01430.
- Jennings JR, Muldoon MF, Ryan C, Price JC, Greer P, Sutton-Tyrrell K, van der Veen FM, Meltzer CC. Reduced cerebral blood flow response and compensation among patients with untreated hypertension. Neurology. 2005 Apr 26;64(8):1358-65. doi: 10.1212/01.WNL.0000158283.28251.3C.
- Ngandu T, Lehtisalo J, Solomon A, Levalahti E, Ahtiluoto S, Antikainen R, Backman L, Hanninen T, Jula A, Laatikainen T, Lindstrom J, Mangialasche F, Paajanen T, Pajala S, Peltonen M, Rauramaa R, Stigsdotter-Neely A, Strandberg T, Tuomilehto J, Soininen H, Kivipelto M. A 2 year multidomain intervention of diet, exercise, cognitive training, and vascular risk monitoring versus control to prevent cognitive decline in at-risk elderly people (FINGER): a randomised controlled trial. Lancet. 2015 Jun 6;385(9984):2255-63. doi: 10.1016/S0140-6736(15)60461-5. Epub 2015 Mar 12.
- Erickson KI, Colcombe SJ, Wadhwa R, Bherer L, Peterson MS, Scalf PE, Kim JS, Alvarado M, Kramer AF. Training-induced functional activation changes in dual-task processing: an FMRI study. Cereb Cortex. 2007 Jan;17(1):192-204. doi: 10.1093/cercor/bhj137. Epub 2006 Feb 8.
- Louis Bherer 2021. "A Combined Multidomain Intervention to Prevent Cognitive Decline Associated With Cardiovascular Risk Factors.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04962061.
Frequently Asked Questions
How many participants are contributing to this research project?
"Affirmative. Clinicaltrials.gov documents the fact that this research project, which was first listed on September 1st 2021, is still enrolling patients. The total count of participants sought after stands at 318 from a single site." - Anonymous Online Contributor
What are the desired outcomes of this trial?
"This experiment's primary goal is to gauge changes in executive functions over the course of 12 months. In addition, secondary objectives include measuring Cerebral VasoReactivity (CVR) using TCD and NIRS on middle cerebral arteries and prefrontal cortex respectively as well as Pulsatility with NIRS applied to the prefrontal cortical region." - Anonymous Online Contributor
Are there any unfilled slots available in this research project?
"Affirmative. As indicated by the clinicaltrials.gov data, this clinical trial is currently accepting participants. This trial was first posted on September 1st 2021 and has most recently been updated on September 29th 2021; 318 individuals need to be recruited from one medical centre." - Anonymous Online Contributor