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NCT Number: NCT05830942

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

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.

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Key information

Conditions

Cognitive Dysfunction Cognition Disorders Frail Elderly Mental Disorders Mobility Limitation Neurocognitive Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida, Gainesville, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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)

    change in walking speed from baseline to post intervention (or follow-up) timepoint

  2. 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)

    change in score from baseline to post intervention (or follow-up) timepoint

Study contacts

Contact information is provided by the study sponsor or research team.

David J Clark, ScD

CONTACT

[email protected]

352-376-1611 ext. 105244

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Cognitively Engaging Walking Exercise and Neuromodulation to Enhance Brain Function in Older Adults

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 26, 2023
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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