Up-2 Study: Cognitively Engaging Walking Exercise and Neuromodulation to Enhance Brain Function in Older Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of Florida
About this trial
Declines in cognitive function and walking function are highly intertwined in older adults. A therapeutic approach that combines complex (cognitively engaging) aerobic walking exercise with non-invasive electrical brain stimulation may be effective at restoring lost function. This study tests whether electrical stimulation of prefrontal brain regions is more beneficial than sham stimulation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 65+
Objective executive function decline, based on standardized cognitive assessments.
Subjective cognitive decline, based on the question: "During the past 12 months, have you experienced confusion or memory loss that is happening more often or getting worse?"
Ability to walking independently for 6 minutes (use of cane permitted)
Disqualifiers
Major cognitive disorder that interferes with independence
Percentile score less than 10th percentile on standardized cognitive assessments
Medications that are thought to influence tDCS neuroplasticity.
Contraindications to tDCS or MRI.
Trial design
Design model
Parallel
Treatments tested in this trial
Walking Exercise
Behavioralaerobic walking exercise using complex (cognitively engaging) walking tasks
Prefrontal Active tDCS
Device20 minutes of 2 milliamp transcranial direct current stimulation (tDCS) of prefrontal regions, delivered at each session
Prefrontal Sham tDCS
Device30 seconds of 2 milliamp transcranial direct current stimulation (tDCS) of prefrontal regions, delivered at each session
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Walking Exercise plus active tDCSActive comparator 2 interventions
Group B: Walking Exercise plus sham tDCSSham comparator 2 interventions
Trial outcomes
Primary outcomes
1
walking speed for obstacle task negotiation task
change in walking speed from baseline to post intervention (or follow-up) timepoint
Time frame
baseline, post-intervention (an average of 6 weeks after baseline), follow-up (an average of 12 weeks after post-intervention)2
score on test of executive function
change in score from baseline to post intervention (or follow-up) timepoint
Time frame
baseline, post-intervention (an average of 6 weeks after baseline), follow-up (an average of 12 weeks after post-intervention)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Florida
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov