Effects of a Bicycling Intervention on Cognitive Skills and Cardiovascular Health (NCT02453178) | Clinical Trial Compass
CompletedNot Applicable
Effects of a Bicycling Intervention on Cognitive Skills and Cardiovascular Health
United States33 participantsStarted 2015-07
Plain-language summary
Although exercise is known to delay cognitive decline and decrease our risk of Alzheimer's Disease, there is a lack of understanding of how exercise protects the aging brain. The proposed research takes a novel approach to this problem by testing the concept that there are acute, direct effects of exercise in the same brain regions that are affected by chronic exercise training. If the investigators are successful, the acute paradigm will allow us to determine the critical exercise parameters that modulate brain function in humans using only a single exercise dose.
Who can participate
Age range
60 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:
* Eligible to participate in an aerobic exercise intervention based on the Physical Activity Readiness Questionnaire, and corrected vision of 20/40.
* Because our older adult sample is over the age of 40, we will also require completion of a detailed health history questionnaire and further eligibility for the exercise intervention will be determined following approval from a physician that monitored electrocardiography (ECG) response during a maximal aerobic fitness test that is part of the second study visit described below.
Exclusion Criteria:
* Not between the ages of 60 and 80 years old
* Not fluent in English
* Score \< 26 (out of 30) on the Montreal Cognitive Assessment (MoCA)
* Inability to comply with experimental instructions
* Qualify as "high risk" for acute cardiovascular event by the published standards of the American College of Sports Medicine
* Left-handed
* Previous diagnosis of neurological, metabolic, or psychiatric condition, and no previous brain injury associated with loss of consciousness
* Inability to complete an MRI
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
1
Functional brain network integrity: the strength of the correlation between fluctuating functional magnetic resonance imaging (fMRI) signal in different brain regions of the Default Mode Network (DMN) and the Executive Control Network (ECN) at rest
Timeframe: Change from baseline functional network integrity at 12-weeks