The STEADFAST research study and how you can participate
Not all research studies require participants. Some, however, do offer the chance for the public to participate, and the Stacking Exercises AIDS the Decline in FVC and Sick Time (STEADFAST) study is currently looking for people to participate in its work on breath stacking techniques and Duchenne muscular dystrophy.
moveit! asked STEADFAST’s principal investigator, Dr. Sherri Katz of the Children’s Hospital of Eastern Ontario (CHEO), some questions about the study, what it involves and how people who are interested can participate.
Q: What is the STEADFAST study about?
A: Breathing complications are the main reason for sickness and death in individuals with Duchenne muscular dystrophy. A technique called “lung volume recruitment” (LVR) is performed using a device consisting of a face mask or mouthpiece and a self-inflating bag. The self-inflating bag is squeezed to push air into the lungs to help inflate them. This helps clear the airways of secretions by increasing the forcefulness of a cough, and it may reduce areas of lung collapse and prevent pneumonia.
We are currently conducting a randomized controlled trial in multiple locations that involves using LVR twice daily in conjunction with conventional treatment. This will be compared to conventional treatment alone, and the impact of LVR therapy on lung function, respiratory infections, hospitalizations and quality of life will be evaluated. If it is effective, this simple treatment eventually will become part of the worldwide standard of care for individuals with Duchenne muscular dystrophy, improving their lung function and quality of life.
Q: What would I need to do as participant in the study?
A: This study is currently recruiting boys aged 6–16 years who have Duchenne muscular dystrophy at nine pediatric centres across Canada. Participants are randomly assigned to receive conventional treatment or a combination of conventional treatment and twice daily LVR. The LVR therapy takes approximately 15 minutes to be administered.
Every six months, there will be a follow-up with patients that involves pulmonary function tests and questionnaires. Study visits can be coordinated with regularly scheduled clinic visits. Participants in the study are followed for two years. To date, 63 individuals from across Canada have been enrolled in the study.
Q: Why should I participate in the study?
A: In retrospective studies in adults, use of LVR has been shown to slow pulmonary function decline in Duchenne muscular dystrophy. Although LVR has been recommended in clinical care guidelines for respiratory management of Duchenne muscular dystrophy—particularly during times of respiratory difficulty—its optimal frequency and duration of use are unknown. This study will determine whether regular use of LVR twice daily slows decline in lung function and/or improves respiratory symptoms. The results of this study will be used to inform recommendations about how LVR should be incorporated into care plans for individuals with Duchenne muscular dystrophy.
Q: Who do I contact if I am interested in participating in the study?
A: Individuals interested in participating in the study should contact the Study Research Coordinator, Ms. Lynda Hoey, at email@example.com. Ms. Hoey will direct them to the nearest participating study site.
STEADFAST is taking place in the following cities: Vancouver, Edmonton, Calgary, London, Hamilton, Toronto and Edmonton. Enrollment in the study will close at the end of May 2016, so if you are interested in participating, be sure to contact the Coordinator at firstname.lastname@example.org!