Home-Based Walking for Thinking Skills in Persons With TBI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Walking.
- Who it may be relevant to
- Registry conditions: Traumatic Brain Injury (TBI) Patients. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Safety and Feasibility of Remote Walking Exercise for Cognitive Improvement in Persons With TBI
Overview
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.
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 meeti
Primary outcome measures
- Adverse Events [Time frame: Through study completion, which is 3 months for intervention and 6 months for wait list.]
- Adherence [Time frame: Through study completion, which is 3 months for intervention and 6 months for wait list.]
- Compliance [Time frame: Through study completion, which is 3 months for intervention and 6 months for wait list.]
Secondary outcome measures (3)
- 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)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Kessler Foundation — East Hanover
Identifiers
NCT: NCT07733284 · E-1314-26