Home-Based Walking for Thinking Skills in Persons With TBI
Purpose
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.
Condition
- Traumatic Brain Injury (TBI) Patients
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- Early Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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). |
|
Recruiting Locations
East Hanover, New Jersey 07936
More Details
- Status
- Recruiting
- Sponsor
- Kessler Foundation
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.