Physical activity and sleep disturbances in individuals with alcohol use disorder: protocol of the APhysOH pilot study for a randomized controlled trial

Abstract Background Physical activity has been shown to improve sleep and may serve as an effective adjunctive therapy in the treatment of alcohol use disorder (AUD). However, few studies have examined the impact of Adapted Physical Activity (APA) programs on sleep in individuals with AUD. This pilot randomized controlled trial (RCT), APhysOH, aims to assess the feasibility of an RCT evaluating the effects of an APA intervention on sleep, alcohol use, and mental and physical health outcomes in individuals with AUD. Methods Forty participants will be recruited and randomized to either an intervention group, referred to as the supervised group ( n = 30), or a control group, referred to as the autonomous group ( n = 10). The intervention consists of a 12-week APA program tailored to the abilities of patients with AUD and designed to improve sleep. It includes aerobic and resistance-based exercises delivered through three one-hour morning sessions per week. The control group will continue usual care and receive educational material on the benefits of physical activity for AUD and sleep. The primary objective of this study is to assess feasibility. Secondary objectives are to evaluate the impact of a supervised APA program on sleep, addiction severity, physical fitness, functional capacity, and mental health in patients with AUD. Both objective and subjective measures will be used, including biomarkers, actigraphy, physical performance tests, validated questionnaires, and diaries recording sleep, physical activity, and alcohol consumption. Discussion Findings from this pilot RCT protocol will inform the design of future large-scale trials by evaluating the feasibility of this type of intervention. The study will also generate preliminary data to estimate the potential effects of APA on sleep, addiction severity, and physical and mental health in individuals with AUD. Trial registration ClinicalTrials.gov identifier: NCT06706349. Registered on 2 June 2024; last updated on 26 November 2024. Sponsor: CHU Besançon, France.