Home-Based Walking for Thinking Skills in Persons With TBI
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKessler Foundation
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Behavioral: ExerciseExperimental treatment 1 intervention
Group B: Wait ListNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Adverse 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.2
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.3
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.Secondary outcomes
1
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)2
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)3
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov