Centre for Alcohol and Drug Research, Stavanger University Hospital, Stavanger, Norway.
Department of Addiction Medicine, Bergen Addiction Research, Haukeland University Hospital, Bergen, Norway.
Trials. 2024 Feb 29;25(1):155. doi: 10.1186/s13063-024-07993-2.
Substance use disorder is associated with unhealthy lifestyle choices, resulting in adverse social and health consequences. People with opioid use disorder receiving opioid agonist therapy, in particular, have high morbidity and reduced quality of life. Physical activity is recommended as an adjunctive treatment for people with substance use disorder, but there is minimal evidence from randomized controlled trials on the effects of this among people with substance use disorder receiving opioid agonist therapy.
BAReAktiv is a multicentre randomized controlled trial. The study aims to recruit 324 patients receiving opioid agonist therapy (parallel groups randomized 1:1 to integrated exercise intervention or control, superiority trial). A 16-week group-based integrated exercise intervention with workouts twice a week. The exercise program consists of endurance and resistance training. The target group will be patients 18 years and older receiving opioid agonist therapy in outpatient clinics in several centers in Western Norway. The primary outcome of the study is the effect on psychological distress measured by Hopkins' symptom checklist with ten items. Secondary outcome measures include physical functioning assessed with a 4-min step test, activity level, fatigue symptoms, quality of life, and changes in inflammation markers. This study will provide improved knowledge on the effects of an integrated exercise program in opioid agonist therapy.
Systematically integrating exercise programs for people receiving opioid agonist therapy could lead to a shift towards a stronger focus on health behaviors in outpatient care. Integrating exercise could benefit patient recovery and reduce disease burden. Further scale-up will be considered if the provided exercise program is safe and effective.
ClinicalTrials.gov. NCT05242848. Registered on February 16, 2022.
物质使用障碍与不健康的生活方式选择有关，导致不良的社会和健康后果。接受阿片类药物激动剂治疗的阿片类药物使用障碍患者尤其患有高发病率和降低的生活质量。身体活动被推荐作为物质使用障碍患者的辅助治疗方法，但在接受阿片类药物激动剂治疗的物质使用障碍患者中，随机对照试验中关于这种治疗效果的证据很少。
BAReAktiv 是一项多中心随机对照试验。该研究旨在招募 324 名接受阿片类药物激动剂治疗的患者（平行组 1:1 随机分为综合运动干预组或对照组，优效性试验）。每周两次的基于小组的综合运动干预，每次锻炼。运动方案包括耐力和阻力训练。目标人群将是在挪威西部几个中心的门诊接受阿片类药物激动剂治疗的 18 岁及以上患者。该研究的主要结果是通过霍普金斯症状清单的 10 项评估心理困扰的效果。次要结果包括用 4 分钟台阶测试评估的身体功能、活动水平、疲劳症状、生活质量和炎症标志物的变化。这项研究将提供关于综合运动方案在阿片类药物激动剂治疗中的效果的更好的知识。
系统地将运动方案整合到接受阿片类药物激动剂治疗的人群中，可能会导致在门诊护理中更加注重健康行为。整合运动可能有益于患者的康复并减轻疾病负担。如果提供的运动方案安全有效，将进一步考虑扩大规模。
ClinicalTrials.gov。NCT05242848。注册于 2022 年 2 月 16 日。
