The STEADFAST research study and how you can participate

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Credit: Dr. Doug McKim, Respirologist, Ottawa Hospital Rehabilitation Centre

Credit: Dr. Doug McKim, Respirologist, Ottawa Hospital Rehabilitation Centre

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 lhoey@cheo.on.ca. 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 lhoey@cheo.on.ca!

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2 Responses

  1. Claudette Petersen says:

    Hi I am inquiring on behalf of my son,Robert who has DMD and uses the LVR, will there be a study for the older guys, who could benefit from this if it is self inflating,by self inflating do you mean it will inflate on its own or does the patient or caregiver still have to conduct the inflating by squeezing the apparatus itself?

    • musclecanada says:

      We reached out to Dr. Sherri Katz, STEADFAST’s principal investigator, Children’s Hospital of Eastern Ontario (CHEO) and Dr. Doug McKim, Respirologist, Ottawa Hospital Rehabilitation Centre for a response to your question.

      Dr. Katz – “We are not currently conducting a study in older individuals, although we have published retrospective data demonstrating benefit of regular LVR therapy in this population. The self-inflating bag is somewhat of a misnomer, as it does not actually inflate itself and would require squeezing by the patient or a caregiver. The most automated method of delivery of LVR would be with an inexsufflator.”

      Dr. McKim – “If the young man uses LVR regularly research will not be any more helpful to him personally. He just needs regular follow up and measurement of VC and peak cough flows before and with LVR.”

      Thanks for your question!

      Do you want to keep informed about developments in neuromuscular research and what is happening in the Muscular Dystrophy Canada community? Join Us and stay connected – http://www.muscle.ca/we-can-help/join-us-stay-connected/

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