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

NCT05830942 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-05-08

No results posted yet for this 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.

Conditions

  • Cognitive Dysfunction
  • Mobility Limitation
  • Frail Elderly

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

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • University of Florida

    lead OTHER

Principal Investigators

  • David J Clark, ScD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-15
Primary Completion
2027-04-30
Completion
2027-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05830942 on ClinicalTrials.gov