Table_5_Feasibility and Potential Effectiveness of a Smartphone Zero-Time Exercise Intervention for Promoting Physical Activity and Fitness in Patients With Coronary Heart Disease: A Pilot Randomized Controlled Trial.pdf

BackgroundZero-time Exercise (ZTEx), a simple strength- and stamina-enhancing physical activity (PA) requiring no extra equipment, can potentially increase PA and fitness. This pilot trial examined the feasibility and potential effectiveness of a smartphone ZTEx intervention to promote PA and fitness in patients with coronary heart disease (CHD).
MethodsA parallel-group assessor-blinded pilot randomized controlled trial was conducted on Chinese patients with stable coronary heart disease (CHD) in three cardiology clinics. The experimental group received a 15-min brief individual face-to-face session and a 12-week ZTEx instant messaging with 28 picture e-messages and a smartphone ZTEx application (ZTExApp). The control group received the same duration of individual session and number and format of e-messages, but the content was healthy eating and breathing exercise. The feasibility was assessed based on: attrition rate, usage, response rate and perception of the intervention. The outcome evaluation included primary outcome (PA), fitness, exercise self-efficacy and intention, perceived happiness and health, and quality of life. A linear mixed model was used with intention-to-treat analysis adjusting for sex, age and baseline values. A semi-structured interview was conducted to collect feedback from the experiment group.
ResultsOne hundred thirty-nine patients (mean age 59.8 ± 6.6; 71.2% male) were randomized to the experimental group (n = 70) or control group (n = 69), and 80% (56/70) and 82% (57/69) of patients completed the 12-week follow-up assessment, respectively. The attrition rate was 18.7%. The experimental group reported that ZTEx was feasible to integrate PA into their daily life and appreciated the picture e-messages, and 95% of them sent feedback to us, but only 19.6% (13/70) of the participants entered their PA information into the e-diary of the ZTExApp. The experimental group had a significantly greater increase in time spent walking [mean difference (95% CI): 155.3 (10.1, 300.4), P = 0.04, Cohen's d = 0.34] than the control group.
ConclusionsThis pilot study showed using a brief ZTEx face-to-face session with picture e-messages empowered patients with CHD to integrate PA into daily life. Future definitive trials with a longer follow-up and a more user-friendly ZTExApp interface are necessary to determine the effectiveness of the smartphone ZTEx intervention in enhancing PA and related outcomes.
Trial RegistrationThe research protocol was registered at the Hong Kong University Clinical Trials Registry (HKUCTR) on 22 Jul 2016 (Study identifier: HKUCTR-2165) and was also retrospectively registered at the National Institutes of Health (identifier number: NCT03464331) on 14 March 2018.

背景：零耗时运动（Zero-time Exercise, ZTEx）是一种无需额外装备的简易力量与耐力提升型身体活动（Physical Activity, PA），有望提升受试者的身体活动水平与健康状态。本先导试验旨在探讨智能手机端ZTEx干预方案在冠心病（Coronary Heart Disease, CHD）患者中推广身体活动、改善健康水平的可行性与潜在效果。方法：本研究于三家心脏科诊所针对中国稳定性冠心病患者开展平行组、评估者设盲的先导随机对照试验。实验组受试者接受15分钟简短个体面对面指导课程，以及为期12周、包含28条图片电子讯息的ZTEx即时通讯服务，搭配智能手机ZTEx应用程序（ZTExApp）。对照组受试者接受相同时长的个体指导课程，以及相同数量与格式的电子讯息，但讯息内容为健康饮食与呼吸训练。可行性评估指标包括脱落率、使用情况、应答率及受试者对干预措施的认知评价。结局评估涵盖主要结局（身体活动）、健康水平、运动自我效能与意愿、感知幸福与健康状况，以及生活质量。本研究采用线性混合模型结合意向性治疗分析，校正性别、年龄及基线值。此外对实验组开展半结构化访谈以收集反馈意见。结果：本研究共纳入139例患者（平均年龄59.8±6.6岁；男性占比71.2%），随机分配至实验组（n=70）与对照组（n=69），两组12周随访评估完成率分别为80%（56/70）与82%（57/69），整体脱落率为18.7%。实验组受试者反馈称，ZTEx便于将身体活动融入日常生活，且认可图片电子讯息的形式，其中95%的受试者提交了反馈，但仅19.6%（13/70）的参与者在ZTExApp的电子日志中录入了自身身体活动信息。实验组步行时长的增幅显著高于对照组[均值差（95%置信区间）：155.3（10.1, 300.4），P=0.04，Cohen's d=0.34]。结论：本先导研究表明，结合图片电子讯息的简短ZTEx面对面指导课程，可帮助冠心病患者将身体活动融入日常生活。未来需开展随访周期更长、ZTExApp界面更易用的确证性试验，以明确智能手机端ZTEx干预方案在提升身体活动及相关结局指标中的有效性。试验注册：本研究方案于2016年7月22日在香港大学临床试验注册中心（HKUCTR）注册（研究编号：HKUCTR-2165），并于2018年3月14日在美国国立卫生研究院（NIH）进行回顾性注册（注册号：NCT03464331）。