Commentary
Video
Author(s):
"We've developed the Get Moving Trial, which is a randomized controlled phase 1/2 trial to demonstrate the safety, feasibility and efficacy of a home-based pre-op program that is personalized," says Sarah P. Psutka, MD, MSc.
During an interview at the 2024 American Urological Association Annual Meeting, Sarah P. Psutka, MD, MSc, discussed the study, “The ‘Get Moving Trial’: A Phase I/II RCT of Home-Based (P)Rehabilitation ((P)REHAB) with ExerciseRx in Muscle-Invasive Bladder Cancer (MIBC): Study protocol for a Randomized Controlled Trial.” Psutka is an associate professor of urology and the associate director of urologic oncology at the University of Washington in Seattle.
Video Transcript:
This is an investigator-initiated trial that we are running at the University of Washington and Fred Hutch. One of the wonderful organizations that I've had the opportunity to work with over the last couple of years is the Bladder Cancer Advocacy Network. They've been phenomenally supportive of our research and trying to understand different ways that we can use a data driven approach to risk stratifying patients and evaluating candidacy for care to try to help patients understand what risks and benefits of treatments might look like for them. But another neat thing that we do is we get to participate in their Think Tank every summer. One of the sessions I've been running the last couple of years has focused on trying to help patients think about how they can start to engage in their care and participate in what's called prehabilitation, or perioperative optimization. There has been this resounding call from the patients saying, "Why isn't this something that's more widely available? Why aren't prehabilitation programs more widely available? Why aren't they something that I can access wherever I am?" This is a really exciting research field. It's widely expanding, it's just rocketing, which is really neat that a lot of people are putting a ton of resources into trying to understand how we can help optimize patients for therapy and how we can help maybe make patients better candidates for therapy. We're talking about a very vulnerable patient population. One of my colleagues, Hannah Hunter, is a physical medicine and rehab doc and a cancer rehab specialist. I sat down with one of our partners in sports medicine to start thinking about, well, why can't we make a prehab protocol that's actually pragmatic? A lot of the studies that have been done, some of them have moved the needle on things like physical function, but have been a little bit more restrictive in terms of the patient populations who could access them. So, we started thinking about whether we could leverage principles of digital health. So, cell phone-based apps to deliver exercise restrictions, but we wanted to take it one step further and wanted to talk about personalized prehab. Because let's face it, everybody needs a little something different to get them ready for the stress of surgery.
We're focusing on an exercise intervention, that is something that is going to be home-based, so everyone can do it at home. It's got to be scalable, something that people can access and not have to come to a gym or a hospital, not have to be observed. We have to be able to prove that people are doing it, so we have to be able to evaluate the adherence rates. And it has to be very targeted to a patient population that's undergoing abdominal surgery. So, we've developed the Get Moving Trial, which is a randomized controlled phase 1/2 trial to demonstrate the safety, feasibility and efficacy of a home-based pre-op program that is personalized. We're hoping to enroll about 128 patients. The goal is to randomize 102, we expect about a 20% drop out based on the prehab literature that's out there. These are personalized exercise interventions, so our participants who are randomized to the prehab arm will undergo a comprehensive assessment with our physical medicine rehab team and receive a personalized exercise prescription that is targeting things like balance, core strength, and mobility. It's exercise interventions that are pretty short and sweet, 30 minutes or less to be done 4 days a week. And it's all delivered through a cell phone-based app. It's called ExerciseRX, [and] that was developed by our team, our sports medicine team for work in trauma populations, in which we have worked with a group of patients and patient advocates to refine for a cancer patient population. In addition to looking at whether or not patients are able to complete the exercises and carrying them out, we're also looking at things like whether or not it moves the needle on physical function, performance assessment. So, we use short physical performance battery, and then also a number of other [measures such as] active time, sedentary time, [and] of course clinical outcomes after surgery such as complications and length of stay, feasibility, utility, patient experience, and quality of life. So, long answer to your question, but it's something we're really excited about. We've been open and enrolling since December. We have 9 patients on trial right now. We're really excited about this endeavor. We have a wonderful team that's working together and a wonderful team of physical medicine, rehab and sports med docs, our urology research program at the University of Washington, and then also an amazing group of engineers who are supporting the rollout of this digital health application. So, that's a little bit about it.
This transcription has been edited for clarity.