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趣味游戏对肺炎儿童呼吸功能和依从性的影响:一项随机对照试验。

PubMed 学科轮询 · 2026-09-07

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摘要 背景:社区获得性肺炎对儿童健康构成重大威胁。传统的呼吸康复由于儿童认知能力有限,往往依从性较差。本研究旨在评估一种基于趣味游戏干预对肺炎患儿呼吸功能、运动能力和康复依从性的影响。 方法:开展了一项单中心、双组、平行对照随机对照试验。从深圳一家三级医院招募了170名肺炎恢复期且符合纳入标准的儿童,随机分为干预组或对照组。最终154名参与者(每组77名)完成了研究。对照组接受常规呼吸训练和健康教育。干预组参加为期8周的趣味游戏项目,包括呼吸训练游戏(如“吹灭小蜡烛”)、体育活动游戏(如“节律呼吸跑”),并辅以互动反馈机制和个性化调整。干预前后分别测量两组的肺功能(FEV1/FVC比值)、运动能力(6分钟步行距离,6MWD)和康复依从性(Frankl和Houpt量表评分)。 结果:两组患者在干预前的基线特征和结局指标差异均无统计学意义(P > 0.05)。8周干预后,与对照组相比,干预组肺功能(FEV1/FVC:84.69 ± 2.34 vs. 74.43 ± 2.27,P < 0.001)和运动能力(6MWD:593.63 ± 19.91 m vs. 556.35 ± 30.48 m,P < 0.001)改善更显著。依从性方面,干预后Frankl评分(3.87 ± 0.34 vs. 3.10 ± 0.60)和Houpt评分(2.91 ± 0.86 vs. 3.19 ± 0.78)显示干预组的合作意愿和治疗完成情况显著优于对照组(P < 0.05)。 结论:趣味游戏干预能显著改善肺炎患儿的肺功能和运动能力,同时有效提高康复治疗中的依从性和完成率。该方法经济、可行且有效,为儿科肺炎的临床护理与康复实践提供了新策略。 临床试验注册:https://www.chictr.org.cn/showproj.html?proj=269965。 《柳叶刀》近期研究结果指出,儿童肺炎是全球公共卫生威胁()。肺炎仍是全世界儿童死亡的首位感染性原因。由于免疫系统未成熟和呼吸道尚在发育(),儿童尤为易感。根据世界卫生组织(WHO)2019年的数据(),肺炎导致逾70万儿童死亡,其中发展中国家负担尤为沉重。在中国,儿童肺炎年发病例数约为2100万,居全球第二位()。该病常病程迁延反复,其中7%至13%的病例可进展为需要住院治疗的危重疾病,严重损害儿童的生长发育和生活质量,同时给其家庭带来沉重负担。尽管在诊断、治疗和预防方面已取得进步,但持续的挑战包括医疗资源受限和抗生素耐药问题()。 胸部物理治疗是处理大多数呼吸系统疾病的重要辅助措施,肺康复是其基本组成部分()。肺康复是儿童呼吸系统疾病管理的核心()。然而,美国胸科学会(ATS)指出,儿童肺康复与成人项目不同,必须根据儿童的年龄和认知能力进行调整()。有效的儿童肺康复需要根据儿童的认知能力进行个体化调整,而传统的以临床医生为主导的模式可能难以满足这一要求。对于认知和理解能力有限的儿童,这种方法往往无法激发其主动参与,导致依从性差和康复效果不理想。 游戏是童年的一种固有属性。通过将游戏元素融入有吸引力的活动中,基于游戏的干预能使儿童在轻松愉快的氛围中完成呼吸康复任务。与常规护理相比,构建一个强调自我决定理论关键概念并提供新颖、有吸引力且具有支架式支持的干预措施的治疗环境,可以增强儿童的参与度()。尽管基于趣味性的游戏引导模式在处理其他疾病方面已显示出成功(, ),但其在儿童肺炎呼吸康复中的应用仍处于探索阶段。因此,本研究探讨该模式如何促进肺炎恢复期儿童在呼吸康复中的依从性与疗效,为改善该人群的结局提供新视角。 方法 研究设计 这项为期8周、双组、平行分组的随机对照试验之前有一个计划阶段,以最终确定趣味游戏干预方案()。 趣味游戏干预方案。 随机分组与分配隐藏 本研究采用区组随机化,固定区组大小为4。分配序列通过基于网络的随机化服务(www.randomization.com)生成。为确保分配隐藏,该序列被放入按顺序编号、不透明、密封的信封中。一名未参与受试者招募或结局收集的工作人员仅在每位参与者完成所有基线评估并正式入组后打开信封。 盲法 由于干预的性质,无法对干预实施者或参与者实施分组盲法。然而,我们尽一切努力减少潜在偏倚:(1)结局评估者在整个研究过程中对分组分配保持盲态;(2)所有干预程序均采用标准化脚本和方案实施;(3)数据分析由一名在最终分析完成前不知道分组代码的研究者进行。 研究对象 肺炎恢复期儿童于2025年5月1日至2025年9月30日期间被纳入。符合条件的参与者患有非重症肺炎,并在接受康复干预前已达到临床稳定。排除患有需要加强呼吸支持或机械通气的重症肺炎的儿童,或患有严重并发症的儿童。纳入标准为:(1)肺炎的临床诊断,经实验室和影像学检查确诊,并分类为();(2)年龄在3至12岁之间;(3)临床稳定,定义为体温正常持续≥3天,症状显著缓解(如咳嗽、呼吸急促),且无影像学进展,由具有>10年临床经验的医生确定;(4)由父母或法定监护人提供书面知情同意。 排除标准为:(1)存在严重并发症(如脓胸、需要机械通气的呼吸衰竭);(2)合并重大全身性疾病(如先天性心脏病、免疫缺陷性疾病);(3)认知障碍导致无法理解游戏说明(如智力残疾);(4)任何其他严重限制参与游戏干预的情况(如严重肌肉骨骼疾病、活动性传染病);(5)同时参加另一项临床研究。 样本量 采用显著性水平(α)为0.05、检验效能(1-β)为0.80的双侧检验,以确保统计效能。基于初步预试验数据,预期游戏引导模式对护理依从性和治疗结果的改善具有中等效应量(Cohen's d = 0.5)。G*Power软件计算出每组所需样本量为68名受试者。为考虑潜在的失访,该数字增加了20%,得出最终总样本量为170名受试者,以确保研究结果的可靠性。 所有主要分析均按照符合方案(PP)原则进行,仅纳入完成干预且无重大方案偏离的参与者。研究期间在多个时间点收集数据。基线评估在干预前1天进行。用力肺活量(FVC)和第一秒用力呼气容积(FEV1)由经过统一培训的技术人员使用儿童肺功能仪测量。6分钟步行试验(6MWT)由指定护士在室内走廊实施。基线人口统计学和临床特征,包括年龄、性别、病程和初始治疗依从性,由同组受过培训的护士通过家长访谈记录。最终结局数据在8周干预完成时收集,重复所有基线测量,并记录研究期间的总依从率和完成率。为确保数据完整性,研究助理每周对所有已收集数据进行交叉核对。 伦理审查 所有参与者均同意数据匿名化。本研究经深圳市人民医院伦理委员会批准(批准号:LL-KY-2025074-01),并在中国临床试验注册中心注册(注册号:ChiCTR2500101623)。 干预方法 在我们的临床环境中,肺康复通常被纳入儿童肺炎恢复期的管理,尤其适用于那些临床稳定后仍有残留呼吸道症状或运动能力受损的患儿。然而,针对儿童肺炎的标准化肺康复方案仍尚未充分建立。既往研究表明,持续数周的呼吸康复干预可改善呼吸系统疾病患儿的呼吸功能、运动能力和治疗依从性(,)。因此,考虑到儿童适应康复活动及达到可测量的功能改善所需的时间,本研究选择了8周干预期。该干预是一项为期8周的结构化、游戏引导式呼吸康复方案。其核心组成部分是通过适龄游戏进行每日呼吸康复训练,旨在训练呼吸控制、改善通气,并促进体力活动中的呼吸协调。这些游戏选自标准化干预手册,并与儿童的发育水平和康复目标相匹配。 该干预由康复治疗师和负责护士实施。康复治疗师负责选择合适的游戏、演示正确的呼吸和动作技巧、在必要时调整难度水平,并确保活动达到预期的康复目标。负责护士协助日常实施,在训练前后提供简短的健康教育,监测安全性和儿童配合情况,并在每次训练后完成保真度检查表。 照护者在家庭练习期间支持干预的实施。他们的角色是帮助儿童完成分配的游戏、鼓励配合、记录训练的完成情况和时长,并报告家庭训练中遇到的任何困难。照护者不得自行修改干预内容或强度;任何必要的调整均与康复治疗师或负责护士讨论。 为提高可重复性和干预保真度,所有干预实施者均遵循标准化操作程序手册,并在实施前完成培训。每次训练均使用保真度核查清单进行检查,最低可接受分数设为85%。研究团队还每周进行督导,包括审查干预进展,并亲自或通过录像随机观察部分训练场次。依从性通过每日出勤记录和照护者完成的居家训练日志进行评估。健康教育被用作辅助组成部分而非核心干预。在干预第一天,照护者参加了一次60分钟的小组课程,解释呼吸康复的原理及游戏引导训练的使用。在8周干预期间,护士在每日训练前后提供简短教育,并每周举行一次20分钟的强化课程,以回顾居家练习、解决照护者报告的困难,并强化正确的训练方法。向照护者提供了一本健康手册,包括带图示的游戏说明、常见康复问题及每周目标设定表()。 对照组健康教育以常规康复知识宣教为主,并在干预开始时进行一次60分钟的集中培训,内容包括反复肺炎患儿日常护理要点,如保暖、饮食禁忌、用药规范等,同时示范腹式呼吸、缩唇呼吸等标准呼吸训练动作。护理人员对家属进行现场指导,例如示范如何将手轻轻放在患儿腹部以感受膈肌运动并评估操作方法。干预期间采用“定期指导+每日监测”的模式,具体为每周2次、每次15分钟的针对性指导。每周第1次指导对呼吸训练完成情况进行检查,并对家属不规范的辅助动作进行纠正;每周第2次指导则针对患儿居家症状观察展开,讲解如何通过咳嗽频率、痰液性状等判断临床变化,以及出现异常情况时如何恰当应对。 结局指标 肺功能为主要结局指标,运动耐量和康复依从性作为次要结局指标进行评估。 肺功能检查 在干预前后进行测试,以测量用力肺活量(FVC)和第一秒用力呼气容积(FEV1)。计算FEV1/FVC比值,数值越高表示肺功能越好。肺功能检查(PFTs)在站立位进行,严格遵守中国肺功能检查指南()。 运动能力 运动能力采用6分钟步行试验(6MWT)进行评估。指导儿童在一条30米长、平坦、笔直的走廊上以尽可能快的速度来回行走6分钟。按规定的时间间隔给予标准化的时间提醒和鼓励,并记录步行总距离(6分钟步行距离,6MWD)。 康复依从性与完成情况 康复依从性采用互补的Frankl和Houpt行为评定量表()进行评估。Frankl量表从1分(肯定不配合)到4分(肯定配合)的4级评分,评估儿童的主观合作意愿。Houpt量表从1分(治疗中断)到6分(优秀)的6级评分,评估治疗执行的实际效果。 两名研究者使用 EpiData 3.1 独立录入数据,并使用 IBM SPSS 26.0 进行统计分析。统计师对分组分配保持盲态。连续变量使用 Kolmogorov–Smirnov 检验进行正态性检验。正态分布数据以均数 ± 标准差表示,非正态分布数据以中位数和四分位数间距表示。使用 Bartlett 检验评估方差齐性。对于正态分布的连续变量,组间比较采用独立样本 t 检验,组内基线与干预后数值的比较采用配对样本 t 检验。非正态分布的连续变量组间比较采用 Mann–Whitney U 检验,组内比较采用 Wilcoxon 符号秩检验。分类变量以频数和百分比表示,并酌情采用卡方检验或 Fisher 精确检验进行比较。 结果 结局评估完成情况 如CONSORT流程图()所示,170名儿童在资格评估后被随机分配。其中,2名儿童无法完成基线评估,因此被排除在最终分析之外。基线评估不完整的原因可能包括:因年龄小配合度有限、难以理解并遵循标准化评估指令、在肺功能检测中无法执行技术上可接受的呼吸动作,以及在肺炎恢复后运动评估期间出现暂时不适或疲劳。在某些情况下,由于注意力持续时间有限或对不熟悉测试程序感到焦虑,儿童无法完成为获得可靠测量结果所需的重复尝试。 参与者入组的CONSORT流程图。 纳入最终分析的所有参与者均在基线和干预后完成了预定的肺功能评估和6分钟步行测试。 基线特征 两组间任何基线人口统计学或临床特征均未发现统计学显著差异(P > 0.05)。观察组男性占54.5%,女性占45.5%,对照组男性占51.9%,女性占48.1%。观察组平均年龄为6.8 ± 2.3岁,对照组为7.1 ± 2.1岁。平均体重分别为22.3 ± 5.8 kg和21.6 ± 5.5 kg。平均病程分别为3.2 ± 1.5天和3.0 ± 1.4天。城市居民分别占两组人数的62.3%和58.4%。大多数监护人具有大专及以上学历(54.5%和53.2%),较低学历水平的分布均衡。两组的主要医疗保险均为城乡居民医保(>84%)。基础疾病发生率分别为15.6%和13.0%。这种人口学特征的一致性证实了两组在干预研究中的可比性()。 受试者一般特征(N = 154)。 肺功能 在基线和干预后使用肺功能仪评估肺功能。记录第1秒用力呼气容积(FEV1)和用力肺活量(FVC)的实测值(升),并用于评估研究期间肺功能的变化()。 干预前后结局([[Inline Image]]±s)。 运动能力 运动能力通过6分钟步行距离(6MWD)进行测量。每名儿童在一条30米长的笔直平坦路线上尽可能快地行走6分钟。整个测试过程中提供标准化的语言鼓励和时间提醒。最终位置记录为终点()。 依从性与完成情况 使用Frankl和Houpt行为评定量表评估依从性,这两个量表分别评估主观意愿和实际程序完成情况。Frankl量表采用4级评分来评估合作意愿:1(明确否定)、2(否定)、3(肯定)、4(明确肯定)。Houpt量表采用5级评分评估行为对操作执行的影响,从1(优秀,治疗完成)到5(中止,未实施治疗)。Houpt量表是一种行为评定量表,用于评估儿童在治疗过程中的合作程度,分数越高表明行为越好,操作完成越成功()。 两组之间所有基线变量的差异均无统计学意义(P > 0.05)。 讨论

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【Abstract】 BACKGROUND: Community-acquired pneumonia poses a significant threat to children's health. Traditional respiratory rehabilitation often suffers from poor adherence due to children's limited cognitive abilities. This study aimed to evaluate the effects of a fun game-based intervention on respiratory function, exercise capacity, and rehabilitation compliance in children with pneumonia. METHODS: A single-center, two-arm, parallel-group randomized controlled trial was conducted. A total of 170 children recovering from pneumonia and meeting the inclusion criteria were recruited from a tertiary hospital in Shenzhen and randomly allocated to either an intervention group or a control group. Ultimately, 154 participants (77 per group) completed the study. The control group received conventional respiratory training and health education. The intervention group participated in an 8-week fun game-based program, including respiratory training games (e.g., "Blow Out the Little Candle"), physical activity games (e.g., "Rhythmic Breathing Run"), along with interactive feedback mechanisms and personalized adjustments. Pulmonary function (FEV1/FVC ratio), exercise capacity (6-min walk distance, 6MWD), and rehabilitation compliance (Frankl and Houpt scale scores) were measured in both groups before and after the intervention. RESULTS: No statistically significant differences were found in baseline characteristics or outcome measures between the two groups before the intervention (P > 0.05). After the 8-week intervention, the intervention group showed significantly greater improvement in pulmonary function (FEV1/FVC: 84.69 ± 2.34 vs. 74.43 ± 2.27, P < 0.001) and exercise capacity (6MWD: 593.63 ± 19.91 m vs. 556.35 ± 30.48 m, P < 0.001) compared to the control group. Regarding compliance, post-intervention Frankl scores (3.87 ± 0.34 vs. 3.10 ± 0.60) and Houpt scores (2.91 ± 0.86 vs. 3.19 ± 0.78) indicated significantly better cooperation willingness and treatment completion in the intervention group (P < 0.05). CONCLUSION: The fun game-based intervention significantly improves pulmonary function and exercise capacity, while effectively enhancing compliance and completion rates in the rehabilitation of children with pneumonia. This approach is economical, feasible, and effective, offering a novel strategy for clinical nursing and rehabilitation practice in pediatric pneumonia. CLINICAL TRIAL REGISTRATION: https://www.chictr.org.cn/showproj.html?proj=269965. 【Introduction】 Recent findings in The Lancet identify childhood pneumonia as a global public health threat (). Pneumonia remains the leading infectious cause of child mortality worldwide. Children are particularly vulnerable due to their immature immune systems and developing respiratory tracts (). According to World Health Organization (WHO) data from 2019 (), pneumonia resulted in over 700,000 child deaths, with a disproportionate burden in developing countries. In China, childhood pneumonia incidence is approximately 21 million cases, the world's second highest (). The disease often follows a prolonged and recurrent course, with 7% to 13% of cases progressing to severe, life-threatening illness requiring hospitalization, This severely compromises children's growth, development, and quality of life while placing a substantial burden on their families. Although advances have been made in diagnosis, treatment, and prevention, persistent challenges include constrained medical resources and antibiotic resistance (). Chest physiotherapy is a crucial adjunctive measure in managing most respiratory diseases, with pulmonary rehabilitation forming a fundamental component (). Pulmonary rehabilitation is the core of respiratory disease management in children (). However, the American Thoracic Society (ATS) has indicated that pediatric pulmonary rehabilitation differs from adult programs and must be tailored to children's age and cognitive abilities (). Effective pediatric pulmonary rehabilitation requires individualized adjustments based on the child's cognitive capacity, whereas the traditional clinician-led model may struggle to meet this requirement. For children with limited cognitive and comprehension abilities, this approach often fails to stimulate active participation, leading to poor adherence and suboptimal rehabilitation outcomes. Game is an innate aspect of childhood. By incorporating gaming elements into engaging activities, game-based interventions allow children to complete respiratory rehabilitation tasks in a relaxed and enjoyable atmosphere. Compared with standard care, constructing a therapeutic environment that emphasizes key concepts of self-determination theory and delivers interventions that are novel, engaging, and scaffolded can enhance children's engagement (). Although the fun-based game-guided model has shown success in managing other conditions (, ). Its application in pediatric pneumonia respiratory rehabilitation remains exploratory. This study therefore investigates how this model promotes compliance and efficacy in the respiratory rehabilitation of children recovering from pneumonia, offering new perspectives for improving outcomes in this population. 【Methods】 【Study design】 This 8-week, two-arm, parallel-group randomized controlled trial was preceded by a planning phase to finalize the fun games intervention protocol (). Fun games intervention protocol. 【Randomization and allocation concealment】 This study used block randomization with a fixed block size of 4. The allocation sequence was generated using a web-based randomization service (www.randomization.com). To ensure allocation concealment, the sequence was placed in sequentially numbered, opaque, sealed envelopes. A staff member who was not involved in participant recruitment or outcome collection opened the envelopes only after each participant had completed all baseline assessments and was formally enrolled. 【Blinding】 Due to the nature of the intervention, it was not feasible to blind the interventionists or the participants to group assignment. However, we made every effort to minimize potential bias: (1) outcome assessors were kept blind to group allocation throughout the study; (2) all intervention procedures were delivered using standardized scripts and protocols; and (3) data analysis was performed by a researcher who was unaware of group codes until the final analysis was completed. 【Study subjects】 Children in the recovery phase after pneumonia were enrolled between May 1, 2025, and September 30, 2025. Eligible participants had non-severe pneumonia and had achieved clinical stability before receiving the rehabilitation intervention. Children with severe pneumonia requiring intensive respiratory support or mechanical ventilation, or those with severe complications, were excluded. Inclusion criteria were: (1) a clinical diagnosis of pneumonia, confirmed by laboratory and imaging findings and classified (); (2) age between 3 and 12 years; (3) clinical stability, defined as normal body temperature for ≥3 days, substantial resolution of symptoms (e.g., cough, tachypnea), and absence of radiographic progression, as determined by a physician with >10 years of clinical experience; and (4) provision of written informed consent by a parent or legal guardian. Exclusion criteria were: (1) presence of severe complications (e.g., empyema, respiratory failure necessitating mechanical ventilation); (2) concomitant major systemic diseases (e.g., congenital heart disease, immunodeficiency disorders); (3) cognitive impairments precluding comprehension of game instructions (e.g., intellectual disability); (4) any other condition severely limiting participation in the play intervention (e.g., severe musculoskeletal disorders, active infectious diseases); and (5) concurrent enrollment in another clinical study. 【Sample size】 A two-sided test with a significance level (α) of 0.05 and a power (1-β) of 0.80 was used to ensure statistical power. Based on preliminary pilot data, a medium effect size (Cohen's d = 0.5) was anticipated for the improvement in nursing compliance and treatment outcomes with the game-guided model. G*Power software calculated a required sample size of 68 participants per group. To account for potential attrition, this number was increased by 20%, yielding a final total sample of 170 participants to ensure the reliability of the findings. 【Data collection】 All primary analyses were performed according to the per-protocol (PP) principle, including only participants who completed the intervention without major protocol deviations. Data were collected at multiple time points throughout the study. Baseline assessments were conducted 1 day prior to the intervention. Forced vital capacity (FVC) and forced expiratory volume in one second (FEV1) were measured by uniformly trained technicians using pediatric spirometers. The 6-min walk test (6MWT) was administered by designated nurses in an indoor corridor. Baseline demographic and clinical characteristics, including age, gender, disease duration, and initial treatment adherence, were recorded by the same trained nurses through parental interviews. Final outcome data were collected upon completion of the 8-week intervention, repeating all baseline measurements and documenting total adherence and completion rates for the study period. To ensure data integrity, research assistants performed weekly cross-checks of all collected data. 【Ethical review】 All participants consented to data anonymization. The study was approved by the Ethics Committee of Shenzhen People's Hospital (Approval No. LL-KY-2025074-01) and registered with the Chinese Clinical Trial Registry (Registration No.: ChiCTR2500101623). 【Intervention methods】 In our clinical setting, pulmonary rehabilitation is routinely incorporated into the management of children recovering from pneumonia, particularly for those with residual respiratory symptoms or impaired exercise capacity after clinical stabilization. However, standardized pulmonary rehabilitation protocols for pediatric pneumonia remain insufficiently established. Previous studies have demonstrated that respiratory rehabilitation interventions lasting several weeks can improve respiratory function, exercise capacity, and treatment adherence in children with respiratory diseases (, ). Therefore, considering the time required for children to adapt to rehabilitation activities and achieve measurable functional improvement, an 8-week intervention period was selected in this study. The intervention was a structured, game-guided respiratory rehabilitation program delivered over 8 weeks. Its core component was daily respiratory rehabilitation through age-appropriate games designed to train breathing control, improve ventilation, and promote respiratory coordination during physical activity. The games were selected from a standardized intervention manual and were matched to the child's developmental level and rehabilitation goals. The intervention was delivered by rehabilitation therapists and responsible nurses. Rehabilitation therapists were responsible for selecting appropriate games, demonstrating the correct breathing and movement techniques, adjusting the difficulty level when necessary, and ensuring that the activities met the intended rehabilitation goals. Responsible nurses assisted with daily implementation, provided brief health education before and after the sessions, monitored safety and child cooperation, and completed fidelity checklists after each session. Caregivers supported the intervention during home practice. Their role was to help the child complete the assigned games, encourage cooperation, record session completion and duration, and report any difficulties encountered during home training. Caregivers were not allowed to independently modify the intervention content or intensity; any necessary adjustment was discussed with the rehabilitation therapist or responsible nurse. To improve reproducibility and intervention fidelity, all interventionists followed a standardized operating procedure manual and completed training before implementation. Each session was checked using a fidelity checklist, with 85% set as the minimum acceptable score. The research team also conducted weekly supervision, including review of intervention progress and random observation of selected sessions either in person or by video recording. Adherence was assessed using daily attendance records and caregiver-completed home training logs. Health education was used as a supporting component rather than the core intervention. On the first day of intervention, caregivers received a 60-min group session explaining the rationale for respiratory rehabilitation and the use of game-guided training. During the 8-week intervention, nurses provided brief education before and after daily sessions, and a 20-min weekly reinforcement session was held to review home practice, address caregiver-reported difficulties, and reinforce correct training methods. A Health Handbook was provided to caregivers, including illustrated game instructions, common rehabilitation questions, and weekly goal-setting tables (). Intervention protocol for games. In the control group, health education focused on disseminating conventional rehabilitation knowledge. A 60-min centralized training session was also conducted at the start of the intervention. This session covered essential daily care points for recurrent pneumonia, such as maintaining warmth, dietary restrictions, and medication standards, alongside demonstrations of standard respiratory training movements like diaphragmatic and pursed-lip breathing. Nursing staff provided on-site guidance to family members, for instance, by showing them how to place hands gently on the child's abdomen to feel diaphragmatic movement and assess technique. During the intervention, a “regular guidance plus daily monitoring” format was implemented through targeted 15-min sessions held twice weekly. The first weekly session reviewed the completion of respiratory exercises and corrected any non-standard assistance from family members. The second session addressed the observation of the child's symptoms at home, explaining how to evaluate clinical changes through cough frequency and sputum characteristics, as well as appropriate responses to any abnormalities. 【Outcome measures】 Pulmonary function was designated as the primary outcome measure, whereas exercise capacity and rehabilitation compliance were evaluated as secondary outcome measures. 【Pulmonary function test】 Test was performed before and after the intervention to measure forced vital capacity (FVC) and forced expiratory volume in one second (FEV1). The FEV1/FVC ratio was calculated, with a higher value indicating better lung function. Pulmonary function tests (PFTs) were performed in the standing position, in strict compliance with the Chinese guidelines for pulmonary function testing (). 【Exercise capacity】 Exercise capacity was assessed using the 6-min walk test (6MWT). Children were instructed to walk back and forth as quickly as possible along a 30-meter, flat, straight corridor for 6 min. Standardized time reminders and encouragement were provided at regular intervals, and the total distance walked (6-min walking distance, 6MWD) was recorded. 【Rehabilitation compliance and completion】 Rehabilitation compliance was evaluated using the complementary Frankl and Houpt behavior rating scales (). The Frankl scale rates a child's subjective willingness to cooperate on a 4-point scale from 1 (definitely negative) to 4 (definitely positive). The Houpt scale rates the actual effectiveness of treatment execution on a 6-point scale from 1 (treatment interrupted) to 6 (excellent). 【Data analysis】 Two researchers independently entered the data using EpiData 3.1, and statistical analyses were performed using IBM SPSS 26.0. The statistician remained blinded to group allocation. Continuous variables were tested for normality using the Kolmogorov–Smirnov test. Normally distributed data are presented as mean ± standard deviation, whereas non-normally distributed data are presented as median and interquartile range. Homogeneity of variance was assessed using Bartlett's test. For normally distributed continuous variables, between-group comparisons were performed using independent-samples t-tests, and within-group comparisons between baseline and post-intervention values were performed using paired-samples t-tests. Non-normally distributed continuous variables were compared using the Mann–Whitney U test for between-group comparisons and the Wilcoxon signed-rank test for within-group comparisons. Categorical variables are presented as frequency and percentage and were compared using the chi-square test or Fisher's exact test, as appropriate. 【Results】 【Completion of outcome assessments】 As shown in the CONSORT flow diagram (), 170 children were randomized after eligibility assessment. Among them, 2 children were unable to complete the baseline assessments and were therefore excluded from the final analysis. The reasons for incomplete baseline assessments may have included limited cooperation due to young age, difficulty understanding and following standardized assessment instructions, inability to perform technically acceptable respiratory maneuvers during pulmonary function testing, and temporary discomfort or fatigue during exercise assessment after pneumonia recovery. In some cases, children were unable to complete repeated attempts required to obtain reliable measurements because of limited attention span or anxiety associated with unfamiliar testing procedures. CONSORT flow diagram of participant enrollment. All participants included in the final analysis completed the scheduled pulmonary function assessment and 6-min walk test at baseline and post-intervention. 【Baseline characteristics】 No statistically significant differences were found in any baseline demographic or clinical characteristics between the groups (P > 0.05). The observation group was 54.5% male and 45.5% female, compared to 51.9% male and 48.1% female in the control group. Mean age was 6.8 ± 2.3 years in the observation group and 7.1 ± 2.1 years in the control group. Mean weight was 22.3 ± 5.8 kg and 21.6 ± 5.5 kg, respectively. Mean illness duration was 3.2 ± 1.5 days and 3.0 ± 1.4 days. Urban residents comprised 62.3% and 58.4% of the groups, respectively. Most guardians had a college education or higher (54.5% and 53.2%), with balanced distributions across lower education levels. The primary medical insurance for both groups was urban-rural resident insurance (>84%). The incidence of underlying diseases was 15.6% and 13.0%, respectively. This demographic consistency confirms the groups' comparability for the intervention study (). General participant characteristics (N = 154). 【Pulmonary function】 Pulmonary function was assessed using spirometry at baseline and after the intervention. Forced expiratory volume in 1 sec (FEV1) and forced vital capacity (FVC) were recorded as measured values in liters and were used to evaluate changes in pulmonary function over the study period (). Pre-post intervention outcomes ([[Inline Image]]±s). 【Exercise capacity】 Exercise capacity was measured via the 6-min walking distance (6MWD). Each child walked as quickly as possible along a 30-meter straight, flat course for 6 min. Standardized verbal encouragement and time reminders were provided throughout the test. The final position was recorded as the endpoint (). 【Compliance and completion】 Compliance was evaluated using both the Frankl and Houpt behavior rating scales, which assess subjective willingness and actual procedural completion, respectively. The Frankl scale rates cooperative willingness on a 4-point scale: 1 (definitely negative), 2 (negative), 3 (positive), and 4 (definitely positive). The Houpt scale rates the behavioral impact on procedure execution on a 5-point scale from 1 (excellent, treatment completed) to 5 (aborted, no treatment rendered). The Houpt scale is a behavioral rating tool used to assess a child's cooperation during treatment, with higher scores indicating better behavior and more successful procedure completion (). There were no statistically significant differences in all baseline variables between the groups (P > 0.05). 【Discussion】 I

English
Effects of fun games on respiratory function and compliance in children with pneumonia: a randomized controlled trial.
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