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

NCT06028334 | Recruiting

• 1 other identifier: iRISID-2023-1533
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Traumatic Brain Injury

Keywords

physical activity; mobile health

Outcome Measures

Primary Outcomes (3)

• Average activity counts/minute

  Actigraphy derived average activity counts/minute from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period

  Baseline

• Average activity counts/minute

  Actigraphy derived average activity counts/minute from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period

  10 weeks after initial randomization

• Average activity counts/minute

  Actigraphy derived average activity counts/minute from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period

  10 weeks after completing GetUp&Go intervention

Secondary Outcomes (27)

• Percent (%) time sedentary

  Baseline

• Percent (%) time sedentary

  10 weeks after initial randomization

• Percent (%) time sedentary

  10 weeks after completing GetUp&Go intervention

• Percent (%) time engaged in moderate-vigorous physical activity (MVPA)

  Baseline

• Percent (%) time engaged in moderate-vigorous physical activity (MVPA)

  10 weeks after initial randomization

Study Arms (2)

Immediate Treatment

EXPERIMENTAL

The 10-week GetUp\&Go intervention will be delivered entirely remotely, with 2 weekly sessions with a therapist delivered over videoconference (Zoom for Healthcare) followed by 3 sessions in weeks 3, 5, and 8, over Zoom or phone according to participant preference. The overall goal of the intervention is to develop and support a personalized plan to increase physical activity and decrease sedentary behavior, in concert with the unique capabilities, opportunities, and motivational factors of each participant. In session 2 and thereafter, RehaBot will be supplied to participants to deliver therapeutic ingredients to supplement those provided by the therapist.

Behavioral: GetUp&Go

Waitlist

PLACEBO COMPARATOR

A 10-week waitlist with baseline and outcome assessment, followed by receipt of the full GetUp\&Go program.

Behavioral: GetUp&Go with 10-Week Delay

Interventions

GetUp&Go BEHAVIORAL

A behavioral treatment combining personalized activity planning and a mobile health application for supporting adherence to activity plans.

Immediate Treatment

GetUp&Go with 10-Week Delay BEHAVIORAL

No assigned treatment during the waitlist phase. Participants in the WL group will be offered the GetUp\&Go intervention, which combines personalized activity planning and a mobile health application, after collection of the primary outcome measure.

Waitlist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein Healthcare Network: lead
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator

Study Sites (1)

Moss Rehabilitation Research Institute

Elkins Park, Pennsylvania, 19027, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Motor Activity

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Behavior

Study Officials

• Amanda Rabinowitz, PhD

  Albert Einstein Healthcare Network

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda Rabinowitz, PhD

CONTACT

215 663-6526; amanda.rabinowitz@jefferson.edu

Lauren Krasucki, DPT, MPH

CONTACT

lauren.krasucki@jefferson.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This project will use masked outcome assessment, with special precautions taken to prevent inadvertent unmasking. These include a "script" reminding participants not to discuss any of their experiences in the trial. Any instances of inadvertent unmasking will be recorded for later analysis of their influence.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Institute Scientist

Model Details: This is a waitlist controlled randomized trial. All participants will receive the GetUp\&Go treatment program. Participants will be randomly assigned with a 50% chance of either receiving immediate treatment (IT) with the 10-week program, or going on a 10-week waitlist, after which they will start the GetUp\&Go program.

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: September 8, 2023
• Study Start: December 19, 2023
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: March 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: All data from this trial will be submitted to FITBIR within one year of the completion of the award, per the FITBIR submission schedule for clinical trials.
• Access Criteria: Projects must be specified for research purposes only (not commercial) with the intention to enhance knowledge for the benefit of human health. Individuals requesting access must have a medical or scientific degree or position relevant for the request. Individuals must be affiliated with a research, industry, or non-profit institution/business/organization. All data access requests must be signed by an individual legally authorized to sign on behalf of the institution/business/organization.

Locations

US (1)