Safety and Feasibility of Remote Walking Exercise for Cognitive Improvement in Persons With TBI
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Adverse Events
Study Overview
Brief 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.
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- 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
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Processing Speed(Baseline and follow-up (12-weeks post-baseline))
- Learning/Memory(Baseline and follow-up (12-weeks post-baseline))
- Executive function(Baseline and follow-up (12-weeks post-baseline))
Investigators
Carly Wender
Principal Investigator
Kessler Foundation