Up-2 Study: Cognitively Engaging Walking Exercise and Neuromodulation to Enhance Brain Function in Older Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Walking Exercise, Prefrontal Active tDCS, Prefrontal Sham tDCS.
- Who it may be relevant to
- Registry conditions: Cognitive Dysfunction, Mobility Limitation, Frail Elderly. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cognitively Engaging Walking Exercise and Neuromodulation to Enhance Brain Function in Older Adults
Overview
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.
Detailed description
Efficacy of transcranial direct current stimulation (tDCS) combined with complex (cognitively engaging) walking exercise in older adults. The primary outcome measures are executive function (computer-based assessment battery) and complex walking function (speed on an obstacle negotiation task). This will be a two-site trial conducted at the University of Florida (lead site) and Brooks Rehabilitation Hospital, which is necessary to achieve enrollment targets and will allow us to develop a multi-site research infrastructure for a future Phase 3 multi-site trial. The study will enroll up to 120 older adult women and men, who exhibit mild to moderate decline of executive function. All experimental groups will receive the same complex walking intervention, which will focus on use of cognitively engaging tasks such as obstacle crossing, accurate foot placement, and walking on complaint surfaces. Each session will consist of 30 minutes of walking. For tDCS, the active treatment group will receive 20 minutes of 2mA tDCS over prefrontal regions F3/F4 ("treatment group"). The second group is a sham control group. tDCS will be delivered simultaneously with complex walking exercise for 18 sessions over a 6-week period. Assessments will be conducted at baseline, post intervention (within one week), and 12 weeks post-intervention.
Interventions
- Behavioral Walking Exercise
aerobic walking exercise using complex (cognitively engaging) walking tasks - Device Prefrontal Active tDCS
20 minutes of 2 milliamp transcranial direct current stimulation (tDCS) of prefrontal regions, delivered at each session - Device Prefrontal Sham tDCS
30 seconds of 2 milliamp transcranial direct current stimulation (tDCS) of prefrontal regions, delivered at each session
Primary outcome measures
- walking speed for obstacle task negotiation task [Time frame: baseline, post-intervention (an average of 6 weeks after baseline), follow-up (an average of 12 weeks after post-intervention)]
- score on test of executive function [Time frame: baseline, post-intervention (an average of 6 weeks after baseline), follow-up (an average of 12 weeks after post-intervention)]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- University of Florida — Gainesville
- Brooks Rehabilitation — Jacksonville
Identifiers
NCT: NCT05830942 · IRB202300001 · PRO00046897 · R01AG081477 · 1R01AG081477-01 · IRB202300002