Jensen Marie-Louise, Storebø Ole Jakob, Bjerrum Merete Bender, Vamosi Marianne
Roskilde University, Roskilde, Denmark
Research Director of Center of Evidence-Based Psychiatry, Psychiatric Research Unit, Region Zealand Psychiatry, Denmark, Department of Psychology, Faculty of Health Science, University of Southern Denmark, Denmark.
BMJ Open. 2024 Dec 22;14(12):e093241. doi: 10.1136/bmjopen-2024-093241.
Attention deficit hyperactivity disorder (ADHD) is a common neurodevelopmental disorder among children and adolescents. The disorder negatively influences their academic performance and social relations, and their quality of life (QoL) is lower than that of peers without ADHD. The majority of children and adolescents with ADHD are treated with medication that potentially has an insufficient effect or frequently occurring adverse events. Physical activity is thought to alter the physiology of ADHD by affecting the same catecholaminergic system in the brain which is targeted by medication.
This protocol is written in accordance with the 'Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols' guideline. Randomised clinical trials with participating children and adolescents between the ages of 3 and 18 years with a primary diagnosis of ADHD or hyperkinetic disorder will be included in the systematic review. The main objective of the review is to examine the effect of physical activity on QoL, executive functions, symptoms and functional impairment in this population. Previous systematic reviews on the effect of physical activity in children and adolescents with ADHD have several methodological and conceptual limitations. These reviews, for example, included both randomised and non-randomised clinical trials or had restrictions regarding the frequency and intensity of the physical activity interventions they included. The present review will include the newest studies in the field and follow the main principles outlined in the 'Cochrane Handbook for Systematic Reviews of Interventions'. Furthermore, it will be the first review in the field to include QoL as an outcome and to apply trial sequential analysis as part of the meta-analysis.
As the systematic review is a secondary analysis of data from primary trials, approval from an ethics committee is not required. The results of the review will be published in a peer-reviewed scientific journal and presented at relevant conferences.
This protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO) on 16 August 2024 (CRD42024576670).
注意缺陷多动障碍（ADHD）是儿童和青少年中常见的神经发育障碍。该障碍对他们的学业成绩和社会关系产生负面影响，其生活质量（QoL）低于无ADHD的同龄人。大多数患有ADHD的儿童和青少年接受药物治疗，但其效果可能不足或经常出现不良事件。体育活动被认为可通过影响大脑中与药物作用靶点相同的儿茶酚胺能系统来改变ADHD的生理状态。
本方案是根据“系统评价与Meta分析方案的首选报告项目”指南编写的。系统评价将纳入年龄在3至18岁之间、初步诊断为ADHD或多动障碍的参与随机临床试验的儿童和青少年。该评价的主要目的是研究体育活动对该人群生活质量、执行功能、症状和功能损害的影响。先前关于体育活动对ADHD儿童和青少年影响的系统评价存在若干方法学和概念上的局限性。例如，这些评价既包括随机临床试验，也包括非随机临床试验，或者对所纳入的体育活动干预的频率和强度有限制。本评价将纳入该领域的最新研究，并遵循《Cochrane干预措施系统评价手册》中概述的主要原则。此外，这将是该领域首次将生活质量作为一项结局指标纳入，并将试验序贯分析应用于Meta分析的一部分。
由于该系统评价是对原始试验数据的二次分析，因此无需伦理委员会批准。评价结果将发表在同行评审的科学期刊上，并在相关会议上展示。
本方案于2024年8月16日在国际前瞻性系统评价注册库（PROSPERO）注册（CRD42024576670）。
