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

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT05830942
Status
Recruiting
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Conditions

  • Cognitive Dysfunction
  • Frail Elderly
  • Mobility Limitation

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Walking Exercise — BEHAVIORAL
    aerobic walking exercise using complex (cognitively engaging) walking tasks
  • Prefrontal Active tDCS — DEVICE
    20 minutes of 2 milliamp transcranial direct current stimulation (tDCS) of prefrontal regions, delivered at each session
  • Prefrontal Sham tDCS — DEVICE
    30 seconds of 2 milliamp transcranial direct current stimulation (tDCS) of prefrontal regions, delivered at each session

Study Details

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.

Key Dates

Start date
Apr 15, 2024
Status verified
Jun 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Walking Exercise plus active tDCS
    The walking exercise will focus on use of complex walking tasks such as obstacle crossing, accurate foot placement, and walking on compliant surfaces. Each session will consist of 30 minutes of walking. Active tDCS will be delivered over prefrontal cortex.
  • Sham Comparator: Walking Exercise plus sham tDCS
    The walking exercise will focus on use of complex walking tasks such as obstacle crossing, accurate foot placement, and walking on compliant surfaces. Each session will consist of 30 minutes of walking. Sham tDCS will be delivered over prefrontal cortex.

Primary Outcome Measure

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) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32610
David J Clark, ScD
[email protected]
352-376-1611
Brooks RehabilitationJacksonvilleFlorida32653
Emily J Fox, PhD
[email protected]

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University of Florida· Gainesville, FLBrooks Rehabilitation· Jacksonville, FL

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