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

Primary Purpose

Cognitive Dysfunction, Mobility Limitation, Frail Elderly

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Walking Exercise
Prefrontal Active tDCS
Prefrontal Sham tDCS
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Dysfunction

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    Walking Exercise plus active tDCS

    Walking Exercise plus sham tDCS

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    walking speed for obstacle task negotiation task
    change in walking speed from baseline to post intervention (or follow-up) timepoint
    score on test of executive function
    change in score from baseline to post intervention (or follow-up) timepoint

    Secondary Outcome Measures

    Full Information

    First Posted
    April 11, 2023
    Last Updated
    September 18, 2023
    Sponsor
    University of Florida
    Collaborators
    National Institute on Aging (NIA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05830942
    Brief Title
    Up-2 Study: Cognitively Engaging Walking Exercise and Neuromodulation to Enhance Brain Function in Older Adults
    Official Title
    Cognitively Engaging Walking Exercise and Neuromodulation to Enhance Brain Function in Older Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2024 (Anticipated)
    Primary Completion Date
    June 30, 2027 (Anticipated)
    Study Completion Date
    June 30, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Florida
    Collaborators
    National Institute on Aging (NIA)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cognitive Dysfunction, Mobility Limitation, Frail Elderly

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Walking Exercise plus active tDCS
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Walking Exercise plus sham tDCS
    Arm Type
    Sham Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Walking Exercise
    Intervention Description
    aerobic walking exercise using complex (cognitively engaging) walking tasks
    Intervention Type
    Device
    Intervention Name(s)
    Prefrontal Active tDCS
    Intervention Description
    20 minutes of 2 milliamp transcranial direct current stimulation (tDCS) of prefrontal regions, delivered at each session
    Intervention Type
    Device
    Intervention Name(s)
    Prefrontal Sham tDCS
    Intervention Description
    30 seconds of 2 milliamp transcranial direct current stimulation (tDCS) of prefrontal regions, delivered at each session
    Primary Outcome Measure Information:
    Title
    walking speed for obstacle task negotiation task
    Description
    change in walking speed from baseline to post intervention (or follow-up) timepoint
    Time Frame
    baseline, post-intervention (an average of 6 weeks after baseline), follow-up (an average of 12 weeks after post-intervention)
    Title
    score on test of executive function
    Description
    change in score from baseline to post intervention (or follow-up) timepoint
    Time Frame
    baseline, post-intervention (an average of 6 weeks after baseline), follow-up (an average of 12 weeks after post-intervention)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    David J Clark, ScD
    Phone
    352-376-1611
    Ext
    105244
    Email
    davidclark@ufl.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David J Clark, ScD
    Organizational Affiliation
    University of Florida
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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