Exercise Intervention Research in Stroke: Optimizing Outcomes Through Treatment Fidelity

Abstract Background: Demonstrating the treatment fidelity of an intervention is a key methodological requirement of any trial testing the impact of the intervention. Purpose: The purpose of this report was to serve as a model for evaluating treatment fidelity in stroke exercise intervention studies and to provide evidence for treatment fidelity in the Exercise Training for Hemiparetic Stroke Intervention Development Study. Methods: Treatment fidelity was evaluated based on study design, training of interventionists, and delivery and receipt of the intervention. Results: There were some concerns about design fidelity as the control group and intervention group traveled to the study location together and received different exercise programs in the same facility. With regard to training of interventionists, observations were utilized to help maintain adherence to the protocol. There was strong support for the delivery and receipt of the intervention with participants exposed to the anticipated number of exercise sessions. As per study protocol, there was evidence that progress toward the proposed physical activity goal was made. Treatment fidelity findings are reported using cumulative data rather than at points throughout the study. Thus the findings may be conservative with regard adherence, for example, to time spent in exercise. Conclusion: In addition to assurance of true testing of the intervention in this study, treatment fidelity of this work provides a useful model for replication and critically important information to better understand the type, dose, and length of exposure to exercise interventions that is needed to optimize stroke recovery.