Home-Based Walking for Thinking Skills in Persons With TBI

NCT07733284 | Recruiting Early Phase 1

• 1 other identifier: E-1314-26
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

walking; thinking; fitbit; exercise

Outcome Measures

Primary Outcomes (3)

• Adverse Events

  Safety will be primarily measured as adverse events, specifically during the remote walking intervention.

  Through study completion, which is 3 months for intervention and 6 months for wait list.

• Adherence

  Adherence is measured as the number of exercise sessions attended compared to the number of total sessions prescribed.

  Through study completion, which is 3 months for intervention and 6 months for wait list.

• Compliance

  Compliance will be measured as the number of exercise sessions completed as prescribed (i.e., intensity and duration).

  Through study completion, which is 3 months for intervention and 6 months for wait list.

Secondary Outcomes (3)

• Processing Speed

  Baseline and follow-up (12-weeks post-baseline)

• Learning/Memory

  Baseline and follow-up (12-weeks post-baseline)

• Executive function

  Baseline and follow-up (12-weeks post-baseline)

Study Arms (2)

Behavioral: Exercise

EXPERIMENTAL

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.

Behavioral: Walking

Wait List

NO INTERVENTION

The other group will stick to a regular routine during this 3-month period (i.e., wait-list group).

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.

Behavioral: Exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kessler Foundation: lead

Study Sites (1)

Kessler Foundation

East Hanover, New Jersey, 07936, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Motor Activity

Interventions

Walking

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Behavior

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Central Study Contacts

Carly Wender, PhD

CONTACT

973-324-8388; cwender@kesslerfoundation.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 29, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: These data will be shared upon completion of data collection (estimated 12/2026) and will be available for three years.
• Access Criteria: Interested parties can request data be shared directly form the PI.

Locations

US (1)