NCT07733284 · Kessler Foundation
Home-Based Walking for Thinking Skills in Persons With TBI
(SWEAT-TBI)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
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 measures
Adverse Events
Time frame: Through study completion, which is 3 months for intervention and 6 months for wait list.
Safety will be primarily measured as adverse events, specifically during the remote walking intervention.
Adherence
Time frame: Through study completion, which is 3 months for intervention and 6 months for wait list.
Adherence is measured as the number of exercise sessions attended compared to the number of total sessions prescribed.
Compliance
Time frame: Through study completion, which is 3 months for intervention and 6 months for wait list.
Compliance will be measured as the number of exercise sessions completed as prescribed (i.e., intensity and duration).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- East Hanover, New Jersey
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 29, 2026 · Source of record for eligibility and locations