It’s no surprise that the COVID-19 pandemic has negatively impacted the segment of the global scientific research community that’s engaged in clinical trials. In the first year of the pandemic, enrolment in clinical trials (other than those for COVID-19 vaccines) plummeted as potential participants understandably shied away from risk and many researchers changed their focus. The number of studies also dipped dramatically—one analysis of US research studies from February to May 2020 found that the number of studies initiated was only 57 percent of what would have been expected had the pandemic not occurred.
One study here in BC that has seen enrolment issues is EPIC-SCI, which stands for Exercise Guidelines Promotion and Implementation in Chronic Spinal Cord Injury (EPIC-SCI): A Randomized Controlled Trial.
The study was spearheaded by ICORD and UBC Okanagan researcher Dr. Kathleen Martin Ginis. She and her team at the Kelowna-based SCI Action Canada Lab set out to evaluate improvements in SCI-related chronic pain in participants who volunteered to follow the International SCI Exercise Guidelines for six months. Here at SCI BC, we were pleased to be consulted during the design of this study, because we know how many peers are severely impacted by chronic pain—and just how few effective treatments there are for it.
The study got underway in 2020, just before the seriousness of COVID-19 became apparent. It has an ambitious goal of recruiting 86 participants from either the Okanagan or Vancouver, who will be randomly allocated to one of two groups. Participants in one group will be asked to immediately follow an exercise program for six months. Participants in the other group (the control group) will be asked not to change their daily lifestyle for six months, and then begin the six-month exercise program. Regardless of when they start, each participant will be given access to a personal trainer to help them set up their exercise program, consisting of two to three hours of exercise per week at home or in a local fitness facility.
Over the course of their six month exercise program, each participant will be required to make three visits to the testing sites (UBC Okanagan in Kelowna or Blusson Spinal Cord Centre in Vancouver), where they would be asked to provide blood samples, complete fitness tests, and take a brief test to see how the body responds to pressure and cold stimuli applied to the arm. In addition, the researchers will contact the participants by phone each week to provide them with motivational support and advice to help them stay on track with their exercise program.
“We initially recruited nine people before the pandemic started, so we really started off with a bang those first three months,” says Martin Ginis. “But we were quickly put on pause due to the COVID-19 pandemic. We have been actively up and running again since this past March, but we’ve struggled to regain the level of interest. Across both the Okanagan and Vancouver sites, we have now had around 26 participants consent to participate in the trial. Of these, 11 participants are currently participating in the intervention, and the remainder have completed their time in the study.”
We have heard anecdotally that it’s been challenging to recruit participants for other studies as well, but this study has been especially challenging,” says Kenedy Olsen, a recent graduate of UBC Okanagan’s Bachelor of Human Kinetics Program who is Clinical Research Coordinator in Martin Ginis’ lab. “Initially, we believe there was hesitancy to participate in research post-pandemic due to the uncertainty of the risks. We would like to reassure people that we have extensive safety precautions in place for in-person visits to protect against COVID-19, and the majority of involvement in this study can be completed remotely as well. If anyone is hesitant to participate because of the risk of COVID-19, we are able to provide PPE as well as ensure our entire staff is wearing it as well during visits. We want to ensure all participants and staff members are kept safe during this process.”
But Olsen admits that there are other obstacles discouraging would-be participants from signing on.
“One of the biggest issues we’re now facing is that individuals are viewing the six-month time commitment as a challenge,” she says. “However, realistically, we only need participants to come to the lab three times. All exercise programs and counselling can be done from home, so if individuals are planning travel or other ventures, this hopefully shouldn’t be a barrier to participating.”
While Martin Ginis concedes that low enrolment has been disheartening, she remains optimistic that more volunteers will come forward—particularly if they understand that their participation is a potential opportunity to be a part of meaningful change.
“We designed this project to create a place for individuals with SCI to become more physically active and we are here to help them do so,” she says. “We want to do this study for the SCI community, and the science and results we get out of it is just a bonus in our eyes. This research project was designed with the input of over 250 people living with SCI and SCI clinicians. This is research designed by people with SCI for people with SCI. We take pride in being a lab that works with the community to ensure the projects we are completing will have meaningful results and actually impact the lives of the people they’re designed to help.”
Additionally, says Olsen, there are perks for individual participants.
“Benefits include receiving a personalized exercise program and two visits with a personal trainer,” she says. “If you live in Vancouver, you can use PARC, and in Kelowna, the UBCO adaptive exercise gym is available to participants as well. However, if you are beyond the distance of these sites, our personal trainer will visit your home or gym with you to ensure you are safely and effectively able to complete your exercise program. You’ll also receive individualized weekly exercise coaching sessions to help keep you on track. We cover gas costs for travelling to and from the testing site, and we also provide a gift card honorarium at the end of the study.”
She adds that participants can learn a lot about their bodies and pain from participating, gain insight about their overall fitness levels, and see what it’s like to go through exercise fitness testing.
“Lastly,” she says, “we hope that anyone who participates in our study will be set up for a lifetime of physical activity participation with all the support we provide during this intervention. We have heard from our participants how they are having some of the best workouts of their life based on the program our trainer makes for them. Many of our participants appear to have greater confidence in the gym and exercise setting after completing this study as well.”
We wanted to hear the thoughts of some SCI BC peers who have signed up to participate in the study. Vancouver’s Jessica Kruger and Kamloops’ William McCreight agreed.
“I finished the study in October,” says Kruger, an incomplete quadriplegic who, as a member of BC’s quad rugby development team, is always physically active. “I’m always keen to participate with studies when time allows for the advancement of knowledge surrounding SCI, and this one just so happened to align pretty nicely with my upcoming wedding, so the added accountability aspect definitely appealed to me. It was definitely a good experience. I felt like, being an active and athletic person, there wasn’t a ton of new knowledge, but the accountability aspect was huge to get me going to the gym more regularly, especially after COVID—if I skip the gym and only I know, not a big deal, but if I skip it and I’m messing up a research study, there are higher stakes.”
McCreight, who is also quadriplegic, was randomly placed in the control group. After no changes in his routine for six months, he’s just started the six month exercise component.
“I liked the idea of helping students with their studies,” he says. “I saw the ad for the study and wanted to take advantage of having a workout routine that was set up specially for myself by a personal trainer. I wanted to train hard for the upcoming wheelchair rugby season. The experience on the control side was okay—I was trying hard to not change my daily routine because of my commitment to the study. Now that I’m done the first half of the study things are going well. I’m enjoying the change in my routine and look forward to my workouts.”
Would Kruger and McCreight recommend participating in EPIC-SCI to other peers? “Definitely,” Kruger says. “It would be especially beneficial to people who are a bit uncertain about what sort of exercises and workouts they should do at the gym.”
McCreight agrees. “If someone has the interest and time, I would recommend this study to them. Just remember you may be on the control side to start. It’s a great group of people and it is a fun atmosphere. The adaptive equipment is great to work with—even for individuals with hand impairment. They’ll adjust your workout routine accordingly to your function.”
Martin Ginis and Olsen are optimistic that peer endorsements like this will help bring about a successful conclusion to the study. “We’re hopeful that, by the end of 2023, we’ll meet our goal of 86 participants, but we want to be realistic as well. When creating research proposals, we factor in potentially having participants drop out or recruiting issues, so we make our expectations a bit more fitting. At the bare minimum, we still need around 65 participants in this study.”
If you’re interested, you can learn more about EPIC-SCI and determine if you’re eligible to participate by visiting icord.org/studies/2021/11/epic-sci. You can also contact Bobo Tong by email (bobo.tong@ubc.ca) or phone (778.581.6487).
This article was originally published in the Winter 2022 issue of The Spin. Read more stories from this issue, including:
- Gynecological care
- ARow & aSki access
- Adaptive motorcycles
And more!
