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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-15

Study Completion Date

2027-04-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Cognitive Dysfunction Mobility Limitation Frail Elderly

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Walking Exercise

Intervention Type BEHAVIORAL

aerobic walking exercise using complex (cognitively engaging) walking tasks

Prefrontal Active tDCS

Intervention Type DEVICE

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

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.

Group Type SHAM_COMPARATOR

Walking Exercise

Intervention Type BEHAVIORAL

aerobic walking exercise using complex (cognitively engaging) walking tasks

Prefrontal Sham tDCS

Intervention Type DEVICE

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

Interventions

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Walking Exercise

aerobic walking exercise using complex (cognitively engaging) walking tasks

Intervention Type BEHAVIORAL

Prefrontal Active tDCS

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

Intervention Type DEVICE

Prefrontal Sham tDCS

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No