Recruiting
Early Phase 1

Walking Exercise

Sponsor:

Kessler Foundation

Code:

NCT07733284

Conditions

Traumatic Brain Injury (TBI) Patients

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Walking

Study Details

Brief summary:

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.

Conditions

Traumatic Brain Injury (TBI) Patients

Study ID

NCT07733284

Start date

Apr 15, 2026

Status verified date

Jul, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Definitive TBI diagnosis at least 1 year prior, verified by medical records
  • Self-report problems with thinking skills since the TBI diagnosis (e.g., processing information, learning or remembering, organizing, multitasking)
  • Between the ages of 18 and 65
  • Access to internet and email
  • Fluent in English
  • Can walk at a brisk pace without using an assistive device
  • Not fallen due to mobility issues from their TBI in the past 6 months
  • Do not currently meet public health guidelines for physical activity
  • Have problems with thinking performance

Exclusion Criteria:

  • I currently have uncontrolled major depression
  • I have a history of schizophrenia, bipolar disorder I or II, or substance-abuse disorders
  • I am regularly taking medications that can affect my thinking, such as antipsychotics or benzodiazepines. Study staff will review my medications to determine if I am taking any that would make me ineligible for this study
  • I have known/diagnosed cardiovascular disease including uncontrolled hypertension, diabetes, or kidney disease
  • I am unable to make everyday decisions on my own

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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).

Interventions

Walking

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Carly Wender, PhD

973-324-8388cwender@kesslerfoundation.org

Locations

Kessler Foundation

Recruiting

East Hanover, New Jersey, United States, 07936

Contacts

Carly Wender, PhD

973-324-8388cwender@kesslerfoundation.org

More Information

Sponsor

Kessler Foundation

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Keywords

  • walking
  • thinking
  • fitbit
  • exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2026-07-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.