Investigating Gains in Neurocognition in an Intervention Trial of Exercise
IGNITE
3 other identifiers
interventional
648
1 country
5
Brief Summary
This randomized control trial will examine whether a 12 month monitored exercise intervention improves brain health in cognitively normal older adults. This trial will also address several important unanswered questions: (1) Are the recommended public health guidelines of 150 minutes/week of exercise sufficient for improving cognitive performance? (2) Does exercise influence brain structure and/or function? (3) Is there a dose-response effect of exercise on the above variables such that greater amounts of exercise brings about greater benefits in cognitive and brain health? (4) What are the mechanisms by which exercise influences brain health? and (5) What factors attenuate or magnify the effects of exercise on brain and cognitive health and contribute to the individual variability in intervention outcomes?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 healthy
Started Sep 2017
Longer than P75 for phase_3 healthy
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2016
CompletedFirst Posted
Study publicly available on registry
August 23, 2016
CompletedStudy Start
First participant enrolled
September 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 11, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 11, 2023
CompletedJune 14, 2024
June 1, 2024
5.6 years
August 12, 2016
June 13, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Cognitive Function
Investigators are assessing change in cognitive function from baseline to 12 months. A comprehensive neuropsychological battery will be used that assesses 5 domains of cognitive function (Working Memory, Processing Speed, Episodic Memory, Attentional Control, and Visuospatial Function). We will perform a confirmatory factor analysis on the cognitive data and determine whether the exercise intervention influences performance as measured by these factors. There is no min and max values. These are generated from a confirmatory factor analysis that normalizes the scores around 0 (being the mean). As such, positive values reflect better performance and negative values reflect poorer cognitive performance. Since the scores are standardized we can calculate the changes in standard deviations - e.g., a shift of 0.5 would be an improvement of ½ standard deviation in performance based on the sample average.
Baseline and 12 months
Secondary Outcomes (1)
Change in brain morphology (Volume)
Baseline and 12 months
Other Outcomes (86)
Change in white matter lesions
Baseline and 12 months
Change in hippocampal subfield volumes
Baseline and 12 months
Change in cortical thickness
Baseline and 12 months
- +83 more other outcomes
Study Arms (3)
150 Minutes Week
EXPERIMENTALParticipants engage in supervised 12 month moderate intensity aerobic exercise intervention with goal of maintaining 150 minutes of exercise per week.
225 Minutes Week
EXPERIMENTALParticipants engage in supervised 12 month moderate intensity aerobic exercise intervention with goal of maintaining 225 minutes of exercise per week.
Stretch and Tone
ACTIVE COMPARATORParticipants engage in supervised 12 month non-cardiorespiratory activity intervention. This group has focus on improving balance, flexibility, and strength.
Interventions
This group will complete aerobic based exercise 150 minutes per week. Participants will obtain minutes through supervised on site exercise and home based exercise. An exercise duration of 30 minutes will be achieved by the forth week of the program and be maintained for the duration of the intervention. Heart rate will be monitored to ensure proper intensity levels. Participants will also be instructed to exercise at home for 30 minutes for two other days of the week at a similar intensity. The prescribed intensity will be 50-60% of the maximum heart rate reserve for weeks one to six and 60-75% for the remainder of the program. Participants in the walking conditions will wear heart rate monitors and be encouraged to walk within their target heart rate zone. During the Covid-19 pandemic shutdown, all intervention exercise was been shifted to home based.
This group will complete aerobic based exercise 225 minutes per week. Participants will obtain minutes through supervised on site exercise and home base exercise. A walking duration of 45 minutes will be achieved by the seventh week of the program. This will be maintained for the duration of the intervention and heart rate will be monitored to ensure proper intensity levels. Participants will be instructed to exercise at home for 45 minutes for two other days of the week at a similar intensity. The prescribed intensity will be 50-60% of the maximum heart rate reserve for weeks one to six and 60-75% for the remainder of the program. Participants in the walking conditions will wear heart rate monitors and be encouraged to walk within their target heart rate zone. During the Covid-19 pandemic shutdown, all intervention exercise has been shifted to home based.
The control condition will focus on improving balance, flexibility, and strength. This group will obtain 150 minutes per week via in person sessions, zoom sessions and home based stretching. Resistance bands, balance disks, yoga blocks, and exercise mats will be used to engage in non-cardiorespiratory activities. These are progressive in nature and include modifications to accommodate injuries, physical difficulties, etc. A new set of similar, yet slightly more challenging activities will be introduced every four weeks. During the first two weeks, participants are introduced to the new activities, and, during the second two weeks, they are encouraged to increase intensity by using more weight or more repetitions. During the current Covid-19 pandemic, all intervention exercise has been shifted to home based.
Eligibility Criteria
You may qualify if:
- Men and women 65 - 80 yrs
- Ambulatory without pain or the assistance of walking devices
- Able to speak and read English
- Exercise level of \<60 minutes per week (less than 20 minutes / 3 days week)
- Medical clearance by PCP
- Living in community for duration of the study
- Reliable means of transportation
- No diagnosis of a neurological disease
- Eligible to undergo MRI
You may not qualify if:
- Current diagnosis of a DSM-V Axis I or II disorder including Major Depression
- History of major psychiatric illness including schizophrenia (not including general anxiety disorder or depression)
- Current treatment for cancer - except non-melanoma skin
- Neurological condition (MS, Parkinson's, Dementia, MCI) or brain injury (traumatic or Stroke)
- Type I Diabetes or insulin-dependent diabetes
- Current alcohol or substance abuse
- Current treatment for congestive heart failure, angina, uncontrolled arrhythmia, DVT or other cardiovascular event
- Myocardial infarction, coronary artery bypass grafting, angioplasty or other cardiac condition in the past year
- Regular use of an assisted walking device
- Presence of metal implants (pacemaker, stents) that would be MR ineligible
- Claustrophobia
- Color Blindness
- Not fluent in English
- Not medically cleared by PCP
- Engaging in \>60 minutes of moderate intensity physical activity (more than 20 minutes day / 3 days per week)
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pittsburghlead
- National Institutes of Health (NIH)collaborator
- National Institute on Aging (NIA)collaborator
Study Sites (5)
University of Illinois
Champaign, Illinois, 15218, United States
University of Kansas
Kansas City, Kansas, 66205, United States
Northeastern University
Boston, Massachusetts, 02115, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Carnegie Mellon University
Pittsburgh, Pennsylvania, 51260, United States
Related Publications (4)
Collins AM, Mellow ML, Wan L, Smith AE, Oberlin LE, Sewell KR, Gothe NP, Fanning J, Migueles JH, Dumuid D, Miatke A, Jakicic JM, Kang C, Grove G, Huang H, Sutton BP, Marsland AL, Kamboh MI, Kramer AF, Hillman CH, Vidoni ED, Burns JM, McAuley E, Erickson KI. Association between 24-h time-use composition and brain age: The IGNITE study. Alzheimers Dement (N Y). 2025 Dec 22;11(4):e70187. doi: 10.1002/trc2.70187. eCollection 2025 Oct-Dec.
PMID: 41445670DERIVEDNorling AM, Lipsitz LA, Dufour AB, Travison TG, Sewell KR, Collins AM, Wan L, Grove G, Huang H, Oberlin LE, Jain S, Karikari TK, Morris JK, Jakicic JM, McAuley E, Kramer AF, Hillman CH, Vidoni ED, Billinger SA, Burns JM, Marsland AL, Kang C, Erickson KI. Arterial stiffness moderates the link between NfL and cognition: The IGNITE study. Alzheimers Dement. 2025 Aug;21(8):e70554. doi: 10.1002/alz.70554.
PMID: 40775489DERIVEDRipperger HS, Reed RG, Kang C, Lesnovskaya A, Aghjayan SL, Huang H, Wan L, Sutton BP, Oberlin L, Collins AM, Burns JM, Vidoni ED, Kramer AF, McAuley E, Hillman CH, Grove GA, Jakicic JM, Erickson KI. Cardiorespiratory fitness, hippocampal subfield morphology, and episodic memory in older adults. Front Aging Neurosci. 2024 Dec 19;16:1466328. doi: 10.3389/fnagi.2024.1466328. eCollection 2024.
PMID: 39749255DERIVEDRaine LB, Erickson KI, Grove G, Watrous JNH, McDonald K, Kang C, Jakicic JM, Forman DE, Kramer AF, Burns JM, Vidoni ED, McAuley E, Hillman CH. Cardiorespiratory fitness levels and body mass index of pre-adolescent children and older adults during the COVID-19 pandemic. Front Public Health. 2023 Jan 17;10:1052389. doi: 10.3389/fpubh.2022.1052389. eCollection 2022.
PMID: 36733279DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kirk I Erickson, PhD
University of Pittsburgh
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 12, 2016
First Posted
August 23, 2016
Study Start
September 6, 2017
Primary Completion
April 11, 2023
Study Completion
April 11, 2023
Last Updated
June 14, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
- Time Frame
- Will be made available after study investigators have published summary data and primary aim results. Will be available for unlimited amount of time.
- Access Criteria
- Data requests will be approved by IGNITE Executive committee. Requests can be made by completing data request form
The data from this study will be made available to outside investigators under a data-sharing agreement. The data will be available to outside investigators after publication of the primary aims and at completion of quality control assessments and data organization. The investigators expect that the data from this study will result in significant interest from internal and external investigators for secondary data analysis and ancillary project proposals, so the investigators will create an oversight committee made up of Principal and Co-Investigators for monitoring, approving, and disseminating the data along with monitoring data analysis plans and development of manuscripts. This is important for eliminating redundant analyses, results, or manuscripts.