RECRUITING

GetUp&Go: A Randomized Controlled Trial of an Intervention to Enhance Physical Activity After TBI

Conditions

Traumatic Brain Injury physical activity mobile health

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to evaluate GetUp\&Go, a program for promoting increased physical activity in individuals at least 6 months post moderate-to-severe traumatic brain injury. GetUp\&Go is a remotely delivered 10-week program that includes one-on-one sessions with a therapist and a mobile health application (RehaBot). The main question is whether participants in the 10-week GetUp\&Go program increase their physical activity, and exhibit associated benefits in mental and physical health, relative to those who are put on a waitlist. * Question 1: Do participants who receive immediate treatment with GetUp\&Go show more increased physical activity, measured by accelerometer activity counts per day, and improve more on secondary outcomes, such as self-reported physical activity, emotional function, fatigue, sleep, pain, and health-related quality of life, compared to their baseline, relative to those who are put on a waitlist? * Question 2: Do participants who have continued access to the mobile health component of the intervention, RehaBot, show better maintenance of physical activity gains compared to those who no longer have access to RehaBot? * Question 3: Are individual participant characteristics associated with participants' response to the treatment program?

Official Title

GetUp&Go: A Randomized Controlled Trial of a Theory-Based Intervention to Enhance Physical Activity in Chronic, Moderate-Severe Traumatic Brain Injury

Quick Facts

Study Start:2023-12-19

Study Completion:2027-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06028334

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age ≥18 * TBI (open or closed), sustained at least 6 months prior to enrollment, of at least complicated-mild/moderate severity as evidenced by loss or alteration of consciousness ≥ 30 minutes; and/or post-traumatic amnesia (PTA) ≥ 24 hours, not due to intoxication/sedation and documented prospectively from the injury; and/or positive neuroimaging findings consistent with TBI * Fully weight bearing on lower limbs and able to walk indoors and outdoors without the assistance of another person * Cognitively able to participate in treatment as judged by ability to travel independently within the community * Able to communicate adequately in English for participation in the treatment protocols * Informed consent given by participant	* Contraindications to increasing PA as judged by study physician, using an exam based on published screening tools * Medical or psychiatric instability, including current psychosis or severe uncontrolled substance misuse, as assessed using items from the SCID/MINI/ASSIST, or suicidal ideation with intent or plan, as assessed by the Columbia-Suicide Severity Rating Scale, screening version * Significant physical or intellectual disability predating the TBI * Neurodegenerative disorder, e.g., Parkinson's disease * Insufficiently inactive, i.e., reporting \> 23 weekly moderate/vigorous activity units on the Godin Leisure-Time Exercise Questionnaire * Planned surgery or other hospitalization during the succeeding 9 months * Physical or sensory disability (e.g., blindness; severe bimanual incoordination) that prevents use of a smartphone

Inclusion Criteria

Exclusion Criteria

* Age ≥18
* TBI (open or closed), sustained at least 6 months prior to enrollment, of at least complicated-mild/moderate severity as evidenced by loss or alteration of consciousness ≥ 30 minutes; and/or post-traumatic amnesia (PTA) ≥ 24 hours, not due to intoxication/sedation and documented prospectively from the injury; and/or positive neuroimaging findings consistent with TBI
* Fully weight bearing on lower limbs and able to walk indoors and outdoors without the assistance of another person
* Cognitively able to participate in treatment as judged by ability to travel independently within the community
* Able to communicate adequately in English for participation in the treatment protocols
* Informed consent given by participant

* Contraindications to increasing PA as judged by study physician, using an exam based on published screening tools
* Medical or psychiatric instability, including current psychosis or severe uncontrolled substance misuse, as assessed using items from the SCID/MINI/ASSIST, or suicidal ideation with intent or plan, as assessed by the Columbia-Suicide Severity Rating Scale, screening version
* Significant physical or intellectual disability predating the TBI
* Neurodegenerative disorder, e.g., Parkinson's disease
* Insufficiently inactive, i.e., reporting \> 23 weekly moderate/vigorous activity units on the Godin Leisure-Time Exercise Questionnaire
* Planned surgery or other hospitalization during the succeeding 9 months
* Physical or sensory disability (e.g., blindness; severe bimanual incoordination) that prevents use of a smartphone

Contacts and Locations

Study Contact

Amanda Rabinowitz, PhD

CONTACT

215 663-6526

amanda.rabinowitz@jefferson.edu

Lauren Krasucki, DPT, MPH

CONTACT

lauren.krasucki@jefferson.edu

Principal Investigator

Amanda Rabinowitz, PhD

PRINCIPAL_INVESTIGATOR

Albert Einstein Healthcare Network

Study Locations (Sites)

Moss Rehabilitation Research Institute

Elkins Park, Pennsylvania, 19027

United States

Collaborators and Investigators

Sponsor: Albert Einstein Healthcare Network

Amanda Rabinowitz, PhD, PRINCIPAL_INVESTIGATOR, Albert Einstein Healthcare Network

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-19

Study Completion Date2027-08-31

Study Record Updates

Study Start Date2023-12-19

Study Completion Date2027-08-31

Terms related to this study

Keywords Provided by Researchers

physical activity
mobile health

Additional Relevant MeSH Terms

Traumatic Brain Injury