Home-Based Walking for Thinking Skills in Persons With TBI

Part of paid clinical trials in East Hanover, New Jersey.

Sponsor
Kessler Foundation
Study ID
NCT07733284
Phase
EARLY_PHASE1
Status
Recruiting

Conditions

  • Traumatic Brain Injury (TBI) Patients

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Walking — BEHAVIORAL
    One group will complete 3-months of walking exercise at home. The exercise program is based on activity guidelines for people with TBI and will be monitored by a trained exercise leader. You will be asked to walk 3 times per week. The first two weeks will require you to walk for 10 minutes at a time, and that duration will increase throughout the 3-months. You will have a dedicated trainer to help get started, answer questions, and support you throughout the programs. You will have regular meetings with this trainer by video conference (Zoom). You will be sent a FitBit to wear on your wrist while exercising to track your steps, and that you will be allowed to keep when the study ends.

Study Details

The purpose of this research study is to investigate the effects of a home-based 3-month long walking exercise program on cognitive (thinking) performance in persons with TBI. As a participant, you will complete this 3-month exercise program now or after a 3-month wait period.

Key Dates

First listed
Jul 29, 2026
Start date
Apr 15, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Behavioral: Exercise
    One group will complete 3-months of walking exercise at home. The exercise program is based on activity guidelines for people with TBI and will be monitored by a trained exercise leader. You will be asked to walk 3 times per week. The first two weeks will require you to walk for 10 minutes at a time, and that duration will increase throughout the 3-months. You will have a dedicated trainer to help get started, answer questions, and support you throughout the programs. You will have regular meetings with this trainer by video conference (Zoom). You will be sent a FitBit to wear on your wrist while exercising to track your steps, and that you will be allowed to keep when the study ends.
  • No Intervention: Wait List
    The other group will stick to a regular routine during this 3-month period (i.e., wait-list group).

Primary Outcome Measure

Adverse Events [ Time Frame: Through study completion, which is 3 months for intervention and 6 months for wait list. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Kessler FoundationEast HanoverNew Jersey07936
Carly Wender, PhD
973-324-8388

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