Presentation Abstract

Tracking Adverse Events During Exercise Programs for Wheelchair Users

Researchers have an ethical obligation under the Good Clinical Practices for human subjects research to obtain participants consent to all procedures, which includes describing potential risks as well as potential benefits. Notably, human subject committees require that researchers record, track, and report adverse events related to intervention procedures. The process includes assessing not only the relationship of the event to the intervention procedures, but also the severity and outcome of the event and to regularly reassess the risk to benefit ratio. Most exercise-related adverse events reported by studies in the general population and among sedentary, chronically ill, or older populations are musculoskeletal injuries with the risk of injury associated with increased exercise intensity, volume, and obesity. Although less common, there is also a risk of falls and cardiovascular events during or after exercise. Investigators are asked to reassess the risk to benefit ratio following each intervention-related adverse event. Because wheelchair users rely upon use of their upper extremities for activities of daily living for years or decades, the risk of exercise causing musculoskeletal injuries should be of great concern for researchers investigating physical activity among wheelchair users. The risk of these injuries is of particular concern for wheelchair users who perform arm-based exercise. Tracking and recording intervention-related adverse events is Good Clinical Practice and should be included in publications. This presentation will describe a standardized approach for tracking adverse events during physical activity or exercise trials that include those directly related to the intervention and those that capture the array of health events participants experience during the study period. Data will be presented from my research program derived from three federally-funded trials (n=334) that targeted increasing the time that participants spent engaged in physical activity over 24 weeks to 52 weeks. Our research team has refined a coding system that categories health events as being related to exercise, musculoskeletal injuries and pain related to the primary disability, other disability-related secondary health problems, other health problems unrelated to the disability that include chronic illnesses and seasonal illnesses plus major health issues and surgeries. The data reveal that exercise-related injuries tend to be infrequent and minor whereas disability-related health events are much more frequent, can be severe, sometimes require hospitalization and surgery and have much greater negative effects on participant retention and intervention effectiveness. Data based on tracking all health-related events during physical activity trials expose notable trends that impact study results, yet have not received adequate attention, which will be described in greater detail during the presentation.

About Dr. Froehlich-Grobe

Katherine Froehlich-Grobe received her master’s and doctoral training in behavioral psychology from the University of Kansas and is currently the Acting Director of Research at Baylor Scott & White Institute for Rehabilitation after spending 16 years in academic settings. Dr. Froehlich-Grobe brings 20 years of research experience conducting studies that explore and promote the health and function of individuals with physical disabilities. She has been awarded federal funding from the NIH, Centers for Disease Control and Prevention (CDC), NIDILRR, and private foundations for her research program in support of developing and testing evidence- and theory-based strategies to promote behavior change around dietary intake and physical activity for individuals with physical disabilities, including SCI. Dr. Froehlich-Grobe’s research has explored both perceived and environmental barriers to exercise facing people with mobility impairment and conducted several pilot studies designed to address exercise barriers faced by wheelchair users, which included lack of available and affordable transportation and accessible equipment combined with teaching behavioral self-management strategies to initiate regular exercise. She has 30 peer-reviewed publications and has presented at numerous professional conferences at the national level.

Dr. Froehlich-Grobe did not disclose any conflicts of interest for this workshop.