Abstract
Exercise has several known benefits in the prevention and treatment of chronic diseases. The implementation of exercise interventions within clinical trials presents numerous inherent challenges including participant safety, exercise adherence and ensuring the fidelity and standardization of the exercise intervention across multiple clinical sites. Previous clinical exercise interventions have been successfully implemented in trials involving diabetes, cardiovascular disease, smoking cessation, and depression. However, to date, the potential benefits of exercise in the treatment of stimulant drug abusers have not been systematically investigated. The STimulant Reduction Intervention using Dosed Exercise (STRIDE) study is designed to investigate the augmentation of treatment as usual with either vigorous exercise or health education. This paper outlines the rationale and considerations that went into the design of the STRIDE exercise intervention, balancing the potential benefit of a vigorous exercise intervention with the demands of addiction treatment and lifestyle rehabilitation. The design of this protocol required a high level of flexibility across all components of the intervention to allow our unique population the ability to integrate in their exercise training sessions while maintaining a maximum level of safety in a population with high levels of co-morbidities and musculoskeletal limitations. The following manuscript addresses the challenges inherent in clinical exercise trials and presents the specific considerations that went into the design and implementation of an exercise intervention customized for use in a clinical trial involving stimulant drug abusers.
► The rationale and design of a clinical exercise intervention is described. ► Stimulant abusers with multiple co-morbidities need enhanced safety procedures. ► Details of the structure the intervention teams and medical screening process. ► Prescription of a clinical dose of exercise based on kilocalories of energy expenditure. ► Strategies for promoting intervention adherence.