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.
Investigating gains in neurocognition in an Intervention Trial of Exercise (IGNITE): Protocol.
K. Erickson,K. Erickson,George Grove,J. Burns,C. Hillman,A. Kramer,A. Kramer,E. McAuley,E. Vidoni,J. Becker,M. Butters,K. Gray,Haiqing Huang,J. Jakicic,M. Kamboh,Chaeryon Kang,W. Klunk,Phil Lee,A. Marsland,J. Mettenburg,R. Rogers,C. Stillman,B. Sutton,A. Szabo-Reed,T. Verstynen,Jennifer C. Watt,A. Weinstein,Mariegold E. Wollam
Published 2019 in Contemporary Clinical Trials
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- Publication year
2019
- Venue
Contemporary Clinical Trials
- Publication date
2019-10-01
- Fields of study
Medicine
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- External record
- Source metadata
Semantic Scholar, PubMed
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