Background: Post-stroke recovery trials pose distinct recruitment and retention challenges, and understanding the financial requirements of conducting randomized controlled trials is crucial to ensure sufficient resources for successful study execution. The purpose of this analysis was to quantify the costs at a single site with a large catchment area of the Moderate-Intensity Exercise Versus High-Intensity Interval Training to Recover Walking Post-Stroke, HIT Stroke Trial.
Methods: To determine cost, study expense reports were gathered and divided into four categories: oversight, recruitment, retention, and outcome assessments. Categories were then further divided into chronological order for initial contact and prescreening, consenting, initial screening, and baseline testing. The 12-week intervention was divided into 4-week blocks: intervention block 1, post 4-week outcome testing, intervention block 2, post 8-week outcome testing, intervention block 3, and post 12-week outcome testing.
Results: Total direct cost for site execution was $539,768 with cost per participant approximated as $35,984. Oversight costs accounted for 65.8% of the budget at $355,661. To achieve goals related to inclusive participant recruitment ($21,923) and retention ($28,009), our site costs totaled $49,932. Direct study-related costs included screening assessments ($5,905), baseline assessments ($15,028), intervention ($76,952), and outcome assessments ($36,288).
Conclusion: Clinical trials on walking rehabilitation and exercise, especially those involving multiple assessment visits, require intensive oversight. This cost analysis provides important and critical insight into the expenses required to successfully execute an exercise-based walking rehabilitation trial in the United States.
Keywords: Aerobic Exercise; Cerebrovascular Accident; Recruitment; Rehabilitation; Retention; Walking.