Recruiting

Cognitively Engaging Walking Exercise & Neuromodulation

Sponsor:

University of Florida

Code:

NCT05830942

Conditions

Cognitive Dysfunction

Mobility Limitation

Frail Elderly

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Walking Exercise

Prefrontal Active tDCS

Prefrontal Sham tDCS

Study Details

Brief 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

Study ID

NCT05830942

Start date

Apr 15, 2024

Status verified date

Jun, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Walking Exercise

aerobic walking exercise using complex (cognitively engaging) walking tasks

Prefrontal Active tDCS

20 minutes of 2 milliamp transcranial direct current stimulation (tDCS) of prefrontal regions, delivered at each session

Prefrontal Sham tDCS

30 seconds of 2 milliamp transcranial direct current stimulation (tDCS) of prefrontal regions, delivered at each session

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) ]
  • 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) ]

Central Contacts and Locations

Central contacts

David J Clark, ScD

352-376-1611davidclark@ufl.edu

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Contacts

David J Clark, ScD

352-376-1611davidclark@ufl.edu

Brooks Rehabilitation

Recruiting

Jacksonville, Florida, United States, 32653

Contacts

Emily J Fox, PhD

ejfox@phhp.ufl.edu

More Information

Sponsor

University of Florida

Last update posted

Jun 3, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-06-03.