GetUp&Go: a Randomized Controlled Trial of a Theory-Based Intervention to Enhance Physical Activity in Chronic, Moderate-Severe Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Average activity counts/minute
研究概览
简要总结
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?
详细描述
The investigators will conduct a Randomized Controlled Trial (RCT) of a novel, remotely delivered physical activity (PA) promotion program, called GetUp&Go-a name selected by focus group participants with moderate-to-severe traumatic brain injury (msTBI). It will be theoretically based, use objective measurement of PA as a primary outcome, and incorporate varied types and amounts of home- and neighborhood-based PA and ways to reduce sedentary behavior, according to participant preferences. Moreover, using a 2-phase design as described below, the investigators will test a method for enhancing longer-term gains in PA using mobile technology, in addition to gains acquired during the first phase of intervention.
Trial design. Participants will undergo baseline testing (T1) and will then be randomized 1:1 to either immediate treatment in GetUp&Go (IT) or waitlist (WL) for 10 weeks. After testing for the primary outcome (T2), the waitlist group will receive GetUp&Go for 10 weeks followed by a T2b evaluation for that group. This phase is called the "A phase", for Acquisition.
Following completion of the GetUp&Go intervention, all participants-regardless of initial group allocation-will be randomized 1:1 to one of two conditions for an additional 10 weeks, the "Follow-Through" (FT) phase. Half of participants will be randomized to the RehaBot condition (RB), which provides continued use of the chatbot to support individualized PA plans, but with no further therapist contact. Participants in the No RehaBot (No RB) condition will not have access to the chatbot. The final evaluation, T3, will occur after the 10-week Follow-Through phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Average activity counts/minute
时间窗: 10 weeks after completing GetUp&Go intervention
Actigraphy derived average activity counts/minute from wrist-worn Actigraph GT3XP averaged over 4 consecutive-wear days over a 7-day period
次要结局
- Emotional function(10 weeks after completing GetUp&Go intervention)
- Subjective pain(10 weeks after completing GetUp&Go intervention)
- Percent (%) time sedentary(10 weeks after completing GetUp&Go intervention)
- Average daily step count(10 weeks after completing GetUp&Go intervention)
- Self-reported PA(10 weeks after completing GetUp&Go intervention)
- Sleep Quality(10 weeks after completing GetUp&Go intervention)
- Health-related Quality of Life(10 weeks after completing GetUp&Go intervention)
- Percent (%) time engaged in moderate-vigorous physical activity (MVPA)(10 weeks after completing GetUp&Go intervention)
- Fatigue(10 weeks after completing GetUp&Go intervention)
研究者
Amanda Rabinowitz
Institute Scientist
Albert Einstein Healthcare Network