CompletedPhase 3

Investigating Gains in Neurocognition in an Intervention Trial of Exercise

United States648 participantsStarted 2017-09-06

Plain-language 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?

Who can participate

Age range

65 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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) * Traveling consecutively for 3 weeks or greater during the study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Cognitive Function

Timeframe: Baseline and 12 months

Trial details

NCT IDNCT02875301

SponsorUniversity of Pittsburgh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-11

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