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 — BEHAVIORALOne 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: ExerciseOne 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 ListThe 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
- Carly Wender, PhD973-324-8388
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Kessler Foundation | East Hanover | New Jersey | 07936 |
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