Up-2 Study: Cognitively Engaging Walking Exercise and Neuromodulation to Enhance Brain Function in Older Adults

Last updated: May 5, 2025
Sponsor: University of Florida
Overall Status: Active - Recruiting

Phase

N/A

Condition

Memory Loss

Mental Disability

Dementia

Treatment

Walking Exercise

Prefrontal Active tDCS

Prefrontal Sham tDCS

Clinical Study ID

NCT05830942
IRB202300001
IRB202300002
1R01AG081477-01
PRO00046897
R01AG081477
  • Ages > 65
  • All Genders

Study Summary

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

Inclusion

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 orgetting worse?"

  • Ability to walking independently for 6 minutes (use of cane permitted)

Exclusion

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.

Study Design

Total Participants: 120
Treatment Group(s): 3
Primary Treatment: Walking Exercise
Phase:
Study Start date:
April 15, 2024
Estimated Completion Date:
April 30, 2027

Study 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.

Connect with a study center

  • University of Florida

    Gainesville, Florida 32610
    United States

    Active - Recruiting

  • Brooks Rehabilitation

    Jacksonville, Florida 32653
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.