HealthyPhase 3IGNITENCT02875301
Investigating Gains in Neurocognition in an Intervention Trial of Exercise
A Phase 3 study testing 150 Minutes Week, 225 Minutes Week and Stretch and Tone in people with Healthy and Cognitive Function 1, Social, run by University of Pittsburgh at 5 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Cognitive Function 1, Social
- What is being tested?
- 150 Minutes Week, 225 Minutes Week and Stretch and Tone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 648 participants
- Where
- 5 sitesUnited States
- Study dates
- 6 Sep 2017to 11 Apr 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Reliable means of transportation
- No diagnosis of a neurological disease
- Eligible to undergo MRI
Who cannot join
- 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
Show all 16Show fewer
- 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)
- Traveling consecutively for 3 weeks or greater during the study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Northeastern University
Boston, Massachusetts, 02115
University of Illinois
Champaign, Illinois, 15218
University of Kansas
Kansas City, Kansas, 66205
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Carnegie Mellon University
Pittsburgh, Pennsylvania, 51260
About this study
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?
Read the detailed description
The investigators are conducting a 12-month, multi-site, randomized dose-response exercise trial (i.e., brisk walking) in 639 cognitively normal adults between 65-80 years of age. Participants will be randomized to a (a) moderate intensity aerobic exercise condition at the public health recommended dose of 150 minutes/week (N=213), (b) a moderate intensity exercise condition at 225 minutes/week (N=213), or (c) a light intensity stretching-and-toning control condition for 150 minutes per week (N=213). Participants will meet 3 days/week for site-based exercise and do home-based activity on two more days of the week for 12 months. A comprehensive state-of-the-science battery of cognitive, MRI, amyloid imaging, physiological biomarkers, cardiorespiratory fitness, physical function, and quality of life measures will be assessed at baseline and after completion of the intervention.
Due to Covid-19 pandemic, the exercise intervention was moved to fully home based during the months of March 2020 through August 2020. During this time, study participants were mailed wrist based heart rate monitors to track intensity. Exercise videos were developed and released to study participants to enhance adherence to the prescribed volume of exercise. Study participants were contacted weekly to obtain weekly exercise volume, mode and intensity. From August 2020 to end of the trial, participants will have flexibility to complete randomized goal of exercise. The study recommends three supervised sessions per week but will work with study participants who feel unsafe exercising in one of the study locations.
The outcome measures to be collected during March 2020 and July 2020 were delayed in those subjects had original intervention end date during this time. For these study participants, many signed a study consent extension and continued the intervention until study sites were allowed to re-open after careful planning and approved mitigation plans at each respective university. Once approved to re-open, participants were scheduled for their post assessment outcome collection.
Specific Aims include:
- Cognitive Enhancement: Using a comprehensive neuropsychological battery and the NIH Toolbox, the investigators will test (a) whether a 12-month moderate intensity exercise intervention improves cognitive performance in older adults and (b) whether the improvements occur in a dose-dependent manner. Hypothesis: PA will enhance cognitive performance non-uniformly with the greatest effects occurring for executive and declarative memory functions. The investigators also predict that these improvements will follow a dose-dependent trajectory with 225 minutes/week of PA demonstrating greater improvements than 150 minutes/week of PA.
- Brain Augmentation: The investigators will test (a) whether a 12-month PA intervention augments MRI markers of brain health and (b) whether changes happen in a dose-dependent manner. Hypothesis: PA will most profoundly influence the volume, microstructural white matter integrity, cerebral blood flow, and connectivity of regions supporting declarative memory (e.g., hippocampus) and executive function (e.g., prefrontal cortex; PFC). Further, the investigators predict that 225 minutes/week will result in greater effects than 150 minutes/week. The investigators predict that these changes in brain outcomes will mediate the cognitive improvements in Aim 1.
- Biomediators: The investigators will test the hypothesis that cardiometabolic, inflammatory, and neurotrophic changes mediate improvements in brain and cognition. Hypothesis: (1) decreases in pro-inflammatory cytokines, (2) decreases in central adiposity, arterial stiffness, and insulin resistance, and (3) increases in brain-derived neurotrophic factor (BDNF) levels will statistically mediate changes in cognitive performance (Aim 1) and brain health (Aim 2), and that the strength of this mediating relationship might vary as a function of certain apriori moderating variables of interest
- Moderators: To examine subgroups (i.e., individual differences) that attenuate or magnify the effect of the intervention on cognitive, brain, and physiological systems to better understand the factors that predict 'responders' versus 'non-responders' to the intervention. The investigators will examine three categories of variables: (1) demographic (e.g., age) (2) genetic (e.g., APOE), and (3) baseline Aβ burden. Hypothesis: The favorable effects of PA on brain and cognition will be greatest for older individuals with greater Aβ burden, and in those with a genetic susceptibility for accelerated cognitive decline.
- Amyloid Diminution: We will test (a) assess Amyloid deposition changes in response to physical activity and (b) whether changes occur in a dose-dependent manner and (c) examine baseline Amyloid as a moderator of intervention effects and (d) examine changes in Amyloid as a mediator of changes in brain and cognition. Hypothesis: We predict that Aβ burden will be attenuated over the course of the intervention for the aerobic exercise groups compared to control group. Further, we predict that 225 minutes/week of aerobic exercise will result in a greater effect on Aβ than 150 minutes/week
- Exploratory Aims: The investigators will explore (a) whether baseline brain health metrics predict adherence and compliance to 12-months of PA, and (b) the utility of multi-modal brain imaging analytical approaches to more comprehensively understand the effects of PA on the aging brain.
- Conditions
- Healthy, Cognitive Function 1, Social
- Being tested
- 150 Minutes Week, 225 Minutes Week, Stretch and Tone
- Keywords
- Exercise, Brain Health, Dose Response, Cognition
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
150 Minutes WeekBehavioural
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.
225 Minutes WeekBehavioural
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.
Stretch and ToneBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 150 Minutes Week | Experimental | Participants engage in supervised 12 month moderate intensity aerobic exercise intervention with goal of maintaining 150 minutes of exercise per week. Receives: Behavioral: 150 Minutes Week |
| 225 Minutes Week | Experimental | Participants engage in supervised 12 month moderate intensity aerobic exercise intervention with goal of maintaining 225 minutes of exercise per week. Receives: Behavioral: 225 Minutes Week |
| Stretch and Tone | Active comparator | Participants engage in supervised 12 month non-cardiorespiratory activity intervention. This group has focus on improving balance, flexibility, and strength. Receives: Behavioral: Stretch and Tone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 months
Secondary outcomes (1)
Change in brain morphology (Volume)
MRI will be used to measure average hippocampal volume and determine changes in volume over the course of the intervention.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study start6 Sep 2017
- Primary completion11 Apr 2023
- Study completion11 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study participants will be randomly assigned to one of three exercise intervention arms.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 648 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Kirk Erickson, PhD, University of Pittsburgh
- Investigators
- Kirk I Erickson, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875301
- Sponsor's protocol ID
- STUDY19070071
- Other IDs
- R01AG053952, R01AG060050
- Acronym
- IGNITE
- Status last verified
- Jun 2024
- First submitted
- 12 Aug 2016
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Norling AM, Collins AM, Sewell KR, Wan L, Grove G, Huang H, Hughes TM, Gepner AD, Sekikawa A, Oberlin LE, Karikari TK, Morris JK, Jakicic JM, Rogers RJ, Forman DE, McAuley E, Kramer AF, Hillman CH, Vidoni ED, Billinger SA, Burns JM, Marsland AL, Kang C, Erickson KI. Decomposed arterial stiffness and NfL-cognition association in older adults: The IGNITE study. Alzheimers Dement (Amst). 2026 Nov 2;18(4):e70507. doi: 10.1002/dad2.70507. eCollection 2026 Oct-Dec.
PubMed 42979025Martin-Fuentes I, Inagaki TK, Solis-Urra P, Oberlin LE, Sewell KR, Karikari TK, Zeng X, Kang C, Morris JK, Ripperger HS, Grove GA, Huang H, Sutton BP, Wan L, Vidoni ED, Marsland AL, Hillman CH, McAuley E, Kramer AF, Burns JM, Erickson KI. Loneliness relates to smaller hippocampal subfield volumes in individuals with elevated plasma pTau217: results from IGNITE. Geroscience. 2026 Oct 23. doi: 10.1007/s11357-026-02614-z. Online ahead of print.
PubMed 42909777Wan L, Kang C, Harrison R, Solis-Urra P, Sewell KR, Oberlin LE, Jain S, Huang H, Grove G, Kamboh MI, Sutton BP, Snitz BE, Kramer AF, McAuley E, Burns JM, Hillman CH, Vidoni ED, Marsland AL, Karikari TK, Morris J, Erickson KI. Neurobiological markers across joint profiles of subjective cognitive decline and objective cognitive function in older adults. Alzheimers Dement. 2026 Aug;22(8):e71743. doi: 10.1002/alz.71743.
PubMed 42576170Molina-Hidalgo C, Villarroel MA, Oberlin LE, Harrison R, Marsland AL, Urdaneta C, Huang H, Jain S, Wan L, Collins AM, Mack M, Grove G, Kramer AF, Hillman CH, Jakicic JM, Vidoni E, Burns J, McAuley E, Kang C, Gujral S, Erickson KI. Sex as a moderator of the association between cardiorespiratory fitness and depressive symptoms in older adults. J Gerontol B Psychol Sci Soc Sci. 2026 Mar 10;81(4):gbag013. doi: 10.1093/geronb/gbag013.
PubMed 41691469Collins 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.
PubMed 41445670Norling 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.
PubMed 40775489Ripperger 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.
PubMed 39749255Raine 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.
PubMed 36733279
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Gains in Neurocognition in an Intervention Trial of Exercise
- ClinicalTrials.gov ID
- NCT02875301
- Acronym / sponsor ID
- IGNITE / STUDY19070071
- Conditions
- Healthy, Cognitive Function 1, Social
- Keywords
- Exercise, Brain Health, Dose Response, Cognition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 648 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Aging (NIA)
- Study start
- 6 Sep 2017 (actual)
- Primary completion
- 11 Apr 2023 (actual)
- Study completion
- 11 Apr 2023 (actual)
- First posted
- 23 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
The investigators are conducting a 12-month, multi-site, randomized dose-response exercise trial (i.e., brisk walking) in 639 cognitively normal adults between 65-80 years of age. Participants will be randomized to a (a) moderate intensity aerobic exercise condition at the public health recommended dose of 150 minutes/week (N=213), (b) a moderate intensity exercise condition at 225 minutes/week (N=213), or (c) a light intensity stretching-and-toning control condition for 150 minutes per week (N=213). Participants will meet 3 days/week for site-based exercise and do home-based activity on two more days of the week for 12 months. A comprehensive state-of-the-science battery of cognitive, MRI, amyloid imaging, physiological biomarkers, cardiorespiratory fitness, physical function, and quality of life measures will be assessed at baseline and after completion of the intervention.
Due to Covid-19 pandemic, the exercise intervention was moved to fully home based during the months of March 2020 through August 2020. During this time, study participants were mailed wrist based heart rate monitors to track intensity. Exercise videos were developed and released to study participants to enhance adherence to the prescribed volume of exercise. Study participants were contacted weekly to obtain weekly exercise volume, mode and intensity. From August 2020 to end of the trial, participants will have flexibility to complete randomized goal of exercise. The study recommends three supervised sessions per week but will work with study participants who feel unsafe exercising in one of the study locations.
The outcome measures to be collected during March 2020 and July 2020 were delayed in those subjects had original intervention end date during this time. For these study participants, many signed a study consent extension and continued the intervention until study sites were allowed to re-open after careful planning and approved mitigation plans at each respective university. Once approved to re-open, participants were scheduled for their post assessment outcome collection.
Specific Aims include:
- Cognitive Enhancement: Using a comprehensive neuropsychological battery and the NIH Toolbox, the investigators will test (a) whether a 12-month moderate intensity exercise intervention improves cognitive performance in older adults and (b) whether the improvements occur in a dose-dependent manner. Hypothesis: PA will enhance cognitive performance non-uniformly with the greatest effects occurring for executive and declarative memory functions. The investigators also predict that these improvements will follow a dose-dependent trajectory with 225 minutes/week of PA demonstrating greater improvements than 150 minutes/week of PA.
- Brain Augmentation: The investigators will test (a) whether a 12-month PA intervention augments MRI markers of brain health and (b) whether changes happen in a dose-dependent manner. Hypothesis: PA will most profoundly influence the volume, microstructural white matter integrity, cerebral blood flow, and connectivity of regions supporting declarative memory (e.g., hippocampus) and executive function (e.g., prefrontal cortex; PFC). Further, the investigators predict that 225 minutes/week will result in greater effects than 150 minutes/week. The investigators predict that these changes in brain outcomes will mediate the cognitive improvements in Aim 1.
- Biomediators: The investigators will test the hypothesis that cardiometabolic, inflammatory, and neurotrophic changes mediate improvements in brain and cognition. Hypothesis: (1) decreases in pro-inflammatory cytokines, (2) decreases in central adiposity, arterial stiffness, and insulin resistance, and (3) increases in brain-derived neurotrophic factor (BDNF) levels will statistically mediate changes in cognitive performance (Aim 1) and brain health (Aim 2), and that the strength of this mediating relationship might vary as a function of certain apriori moderating variables of interest
- Moderators: To examine subgroups (i.e., individual differences) that attenuate or magnify the effect of the intervention on cognitive, brain, and physiological systems to better understand the factors that predict 'responders' versus 'non-responders' to the intervention. The investigators will examine three categories of variables: (1) demographic (e.g., age) (2) genetic (e.g., APOE), and (3) baseline Aβ burden. Hypothesis: The favorable effects of PA on brain and cognition will be greatest for older individuals with greater Aβ burden, and in those with a genetic susceptibility for accelerated cognitive decline.
- Amyloid Diminution: We will test (a) assess Amyloid deposition changes in response to physical activity and (b) whether changes occur in a dose-dependent manner and (c) examine baseline Amyloid as a moderator of intervention effects and (d) examine changes in Amyloid as a mediator of changes in brain and cognition. Hypothesis: We predict that Aβ burden will be attenuated over the course of the intervention for the aerobic exercise groups compared to control group. Further, we predict that 225 minutes/week of aerobic exercise will result in a greater effect on Aβ than 150 minutes/week
- Exploratory Aims: The investigators will explore (a) whether baseline brain health metrics predict adherence and compliance to 12-months of PA, and (b) the utility of multi-modal brain imaging analytical approaches to more comprehensively understand the effects of PA on the aging brain.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Study participants will be randomly assigned to one of three exercise intervention arms.
| Arm | Type | Receives |
|---|---|---|
| 150 Minutes Week | Experimental | Behavioral: 150 Minutes WeekParticipants engage in supervised 12 month moderate intensity aerobic exercise intervention with goal of maintaining 150 minutes of exercise per week. |
| 225 Minutes Week | Experimental | Behavioral: 225 Minutes WeekParticipants engage in supervised 12 month moderate intensity aerobic exercise intervention with goal of maintaining 225 minutes of exercise per week. |
| Stretch and Tone | Active comparator | Behavioral: Stretch and ToneParticipants engage in supervised 12 month non-cardiorespiratory activity intervention. This group has focus on improving balance, flexibility, and strength. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 150 Minutes WeekThis 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. | Behavioural | 150 Minutes Week |
| 225 Minutes WeekThis 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. | Behavioural | 225 Minutes Week |
| Stretch and ToneThe 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. | Behavioural | Stretch and Tone |
Primary outcome
Change in Cognitive Function
Time frame: Baseline and 12 months
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.
1 secondary outcome
Change in brain morphology (Volume)
Time frame: Baseline and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Derived from this study: PubMed 42979025Norling AM, Collins AM, Sewell KR, Wan L, Grove G, Huang H, Hughes TM, Gepner AD, Sekikawa A, Oberlin LE, Karikari TK, Morris JK, Jakicic JM, Rogers RJ, Forman DE, McAuley E, Kramer AF, Hillman CH, Vidoni ED, Billinger SA, Burns JM, Marsland AL, Kang C, Erickson KI. Decomposed arterial stiffness and NfL-cognition association in older adults: The IGNITE study. Alzheimers Dement (Amst). 2026 Nov 2;18(4):e70507. doi: 10.1002/dad2.70507. eCollection 2026 Oct-Dec.
- Derived from this study: PubMed 42909777Martin-Fuentes I, Inagaki TK, Solis-Urra P, Oberlin LE, Sewell KR, Karikari TK, Zeng X, Kang C, Morris JK, Ripperger HS, Grove GA, Huang H, Sutton BP, Wan L, Vidoni ED, Marsland AL, Hillman CH, McAuley E, Kramer AF, Burns JM, Erickson KI. Loneliness relates to smaller hippocampal subfield volumes in individuals with elevated plasma pTau217: results from IGNITE. Geroscience. 2026 Oct 23. doi: 10.1007/s11357-026-02614-z. Online ahead of print.
- Derived from this study: PubMed 42576170Wan L, Kang C, Harrison R, Solis-Urra P, Sewell KR, Oberlin LE, Jain S, Huang H, Grove G, Kamboh MI, Sutton BP, Snitz BE, Kramer AF, McAuley E, Burns JM, Hillman CH, Vidoni ED, Marsland AL, Karikari TK, Morris J, Erickson KI. Neurobiological markers across joint profiles of subjective cognitive decline and objective cognitive function in older adults. Alzheimers Dement. 2026 Aug;22(8):e71743. doi: 10.1002/alz.71743.
- Derived from this study: PubMed 41691469Molina-Hidalgo C, Villarroel MA, Oberlin LE, Harrison R, Marsland AL, Urdaneta C, Huang H, Jain S, Wan L, Collins AM, Mack M, Grove G, Kramer AF, Hillman CH, Jakicic JM, Vidoni E, Burns J, McAuley E, Kang C, Gujral S, Erickson KI. Sex as a moderator of the association between cardiorespiratory fitness and depressive symptoms in older adults. J Gerontol B Psychol Sci Soc Sci. 2026 Mar 10;81(4):gbag013. doi: 10.1093/geronb/gbag013.
- Derived from this study: PubMed 41445670Collins 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.
- Derived from this study: PubMed 40775489Norling 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.
- Derived from this study: PubMed 39749255Ripperger 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.
- Derived from this study: PubMed 36733279Raine 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirk I Erickson, PhD principal investigator
University of Pittsburgh
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 150 Minutes Week, 225 Minutes Week and Stretch and Tone in people with Healthy and Cognitive Function 1, Social, run by University of Pittsburgh at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cognitive Function (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02875301, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.