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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
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.
Kessler Foundation
East Hanover, New Jersey, United States
RECRUITINGAdverse Events
Safety will be primarily measured as adverse events, specifically during the remote walking intervention.
Time frame: 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.
Time frame: 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).
Time frame: Through study completion, which is 3 months for intervention and 6 months for wait list.
Processing Speed
Neuropsychological assessments will be administered to measure processing speed using the symbol digit modalities test (SDMT).
Time frame: 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).
Time frame: 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).
Time frame: Baseline and follow-up (12-weeks post-baseline)
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