Investigating Gains in Neurocognition in an Intervention Trial of Exercise (IGNITE): Protocol

• Published in: Contemporary clinical trials Vol. 85; p. 105832
• Main Authors: Erickson, Kirk I., Grove, George A., Burns, Jeffrey M., Hillman, Charles H., Kramer, Arthur F., McAuley, Edward, Vidoni, Eric D., Becker, James T., Butters, Meryl A., Gray, Katerina, Huang, Haiqing, Jakicic, John M., Kamboh, M. Ilyas, Kang, Chaeryon, Klunk, William E., Lee, Phil, Marsland, Anna L., Mettenburg, Joseph, Rogers, Renee J., Stillman, Chelsea M., Sutton, Bradley P., Szabo-Reed, Amanda, Verstynen, Timothy D., Watt, Jennifer C., Weinstein, Andrea M., Wollam, Mariegold E.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.10.2019
• Subjects: Absorptiometry, Photon; Aged; Aged, 80 and over; Aging; Brain; Brain - diagnostic imaging; Cardiorespiratory Fitness; Cognition; Cognition - physiology; Cognitive Aging - physiology; Cognitive Aging - psychology; Exercise; Exercise - physiology; Exercise - psychology; Female; Humans; Magnetic Resonance Imaging; Male; MRI; Neuroimaging; Neuropsychological Tests; Pulse Wave Analysis; Randomized clinical trial; Randomized Controlled Trials as Topic; Surveys and Questionnaires; Aging; Brain; Cognition; Randomized clinical trial; Exercise; MRI
• ISSN: 1551-7144; 1559-2030
• DOI: 10.1016/j.cct.2019.105832

Despite the ubiquity of normal age-related cognitive decline there is an absence of effective approaches for improving neurocognitive health. Fortunately, moderate intensity exercise is a promising method for improving brain and cognitive health in late life, but its effectiveness remains a matter of skepticism and debate because of the absence of large, comprehensive, Phase III clinical trials. Here we describe the protocol for such a randomized clinical trial called IGNITE (Investigating Gains in Neurocognition in an Intervention Trial of Exercise), a study capable of more definitively addressing whether exercise influences cognitive and brain health in cognitively normal older adults. We are conducting a 12-month, multi-site, randomized dose-response exercise trial in 639 cognitively normal adults between 65 and 80 years of age. Participants are randomized to (1) a moderate intensity aerobic exercise condition of 150 min/week (N = 213), (2) a moderate intensity aerobic exercise condition at 225 min/week (N = 213), or (3) a light intensity stretching-and-toning control condition for 150 min/week (N = 213). Participants are engaging in 3 days/week of supervised exercise and two more days per week of unsupervised exercise for 12 months. A comprehensive cognitive battery, blood biomarkers and battery of psychosocial questionnaires is assessed at baseline, 6 and 12-months. In addition, brain magnetic resonance imaging, physiological biomarkers, cardiorespiratory fitness, physical function, and positron emission tomography of amyloid deposition are assessed at baseline and at the 12-month follow-up. The results from this trial could transform scientific-based policy and health care recommendations for approaches to improve cognitive function in cognitively normal older adults.