Traumatic Brain Injury (TBI) PatientsEarly Phase 1SWEAT-TBINCT07733284
Home-Based Walking for Thinking Skills in Persons With TBI
A Early Phase 1 study testing Walking in people with Traumatic Brain Injury (TBI) Patients, run by Kessler Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury (TBI) Patients
- What is being tested?
- Walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2026to Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Feasibility of Remote Walking Exercise for Cognitive Improvement in Persons With TBI
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.
Read the detailed description
This study involves no in-person visits to Kessler Foundation and takes place at home.
The first study activity will last about 1 hour in total and will involve using videoconferencing software (Zoom) to take tests of thinking (e.g., matching shapes and number, learning a list of words). You will then complete several brief questionnaires about everyday activities and TBI symptoms over the computer.
You will then be randomly picked (like the flip of a coin) by a computer to participate in one of two groups. You will have a 50/50 chance of being placed in either group.
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.
The other group will stick to a regular routine during this 3-month period (i.e., wait-list group).
At the end of the 3-month exercise program, you will repeat the thinking tests and questionnaires. The wait-list group will be given the exercise prescription after this last Zoom session.
- Conditions
- Traumatic Brain Injury (TBI) Patients
- Being tested
- Walking
- Keywords
- walking, thinking, fitbit, exercise
- Medical subject headings
- Brain Injuries, Traumatic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WalkingBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Safety will be primarily measured as adverse events, specifically during the remote walking intervention.
Measured: 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.
Measured: 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).
Measured: Through study completion, which is 3 months for intervention and 6 months for wait list.
Secondary outcomes (3)
Processing Speed
Neuropsychological assessments will be administered to measure processing speed using the symbol digit modalities test (SDMT).
Measured: Baseline and follow-up (12-weeks post-baseline)
Learning/Memory
Neuropsychological assessments will be administered to measure processing learning and memory using the California Verbal Learning Test (CVLT).
Measured: Baseline and follow-up (12-weeks post-baseline)
Executive function
Neuropsychological assessments will be administered to measure executive function using the Delis-Kaplan Executive Function System (DKEFS).
Measured: Baseline and follow-up (12-weeks post-baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start15 Apr 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain Injury (TBI) PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carly Wender, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733284
- Sponsor's protocol ID
- E-1314-26
- Acronym
- SWEAT-TBI
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share sample data on safety measures, adherence, and compliance.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Remote Walking Exercise for Cognitive Improvement in Persons With TBI
- ClinicalTrials.gov ID
- NCT07733284
- Acronym / sponsor ID
- SWEAT-TBI / E-1314-26
- Conditions
- Traumatic Brain Injury (TBI) Patients
- Keywords
- walking, thinking, fitbit, exercise
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study involves no in-person visits to Kessler Foundation and takes place at home.
The first study activity will last about 1 hour in total and will involve using videoconferencing software (Zoom) to take tests of thinking (e.g., matching shapes and number, learning a list of words). You will then complete several brief questionnaires about everyday activities and TBI symptoms over the computer.
You will then be randomly picked (like the flip of a coin) by a computer to participate in one of two groups. You will have a 50/50 chance of being placed in either group.
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.
The other group will stick to a regular routine during this 3-month period (i.e., wait-list group).
At the end of the 3-month exercise program, you will repeat the thinking tests and questionnaires. The wait-list group will be given the exercise prescription after this last Zoom session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral: Exercise | Experimental | Behavioral: WalkingOne 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. |
| Wait List | No intervention | –The other group will stick to a regular routine during this 3-month period (i.e., wait-list group). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WalkingOne 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. | Behavioural | Behavioral: Exercise |
Primary outcome
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).
3 secondary outcomes
Processing Speed
Time frame: Baseline and follow-up (12-weeks post-baseline)
Learning/Memory
Time frame: Baseline and follow-up (12-weeks post-baseline)
Executive function
Time frame: Baseline and follow-up (12-weeks post-baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Yes. We plan to share sample data on safety measures, adherence, and compliance.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Walking in people with Traumatic Brain Injury (TBI) Patients, run by Kessler Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: Through study completion, which is 3 months for intervention and 6 months for wait list.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.