Ma Shuangliang, Chen Zhongxiu, Zhang Junyan, Liu Jiani, Xu Lin, Huang Baotao, Zhou Mingang, Wang Hua, Chen Yong, Wang Mian, Li Chen, He Yong
Department of Cardiology, West China Hospital of Sichuan University, Chengdu, Sichuan, China.
Rehabilitation Medicine Center, West China Hospital of Sichuan University, Chengdu, China.
Digit Health. 2025 Jul 25;11:20552076251360885. doi: 10.1177/20552076251360885. eCollection 2025 Jan-Dec.
Prior research has shown that home-based cardiac rehabilitation (HBCR) and center-based cardiac rehabilitation (CR) achieve comparable clinical outcomes in patients at low to moderate cardiovascular risk. However, the effectiveness of HBCR in high-risk patients remains uncertain. This study evaluates the efficacy of a DTx-integrated, multidisciplinary HBCR program as an alternative to usual care in high-risk patients following percutaneous coronary intervention (PCI).
The DTx-HBCR trial is a parallel-arm, randomized controlled trial that will enroll 366 high-risk patients undergoing PCI at West China Hospital of Sichuan University. Participants will be randomly assigned in a 1:1 ratio to either a 6-month DTx-HBCR group (intervention group) or a 6-month usual care group (control group). Following the intervention period, both groups will be observed for an additional 6-month follow-up without active intervention. Outcome assessments will be conducted at baseline and at 3, 6, and 12 months post-randomization. The primary outcome is the between-group difference in functional capacity at 6 months, assessed by the 6-minute walk test. Key secondary outcomes include changes in cardiovascular health metrics (i.e., smoking status, blood pressure, glycosylated hemoglobin, lipid profile, body mass index, and physical activity), health-related quality of life, psychological well-being, and adherence to evidence-based cardioprotective medications. All analyses will be conducted according to the intention-to-treat principle.
The DTx-HBCR trial is a novel randomized controlled clinical study designed to evaluate the efficacy of DTx-integrated HBCR program in improving functional capacity in high-risk patients following PCI. This DTx-integrated intervention has the potential to enhance cardiovascular health outcomes in this high-risk population.
NCT06542575 (ClinicalTrials.gov).
先前的研究表明，家庭心脏康复（HBCR）和中心心脏康复（CR）在心血管风险低至中度的患者中可取得相当的临床效果。然而，HBCR在高危患者中的有效性仍不确定。本研究评估了一种集成数字疗法（DTx）的多学科HBCR计划作为经皮冠状动脉介入治疗（PCI）后高危患者常规护理替代方案的疗效。
DTx-HBCR试验是一项平行组随机对照试验，将招募366例在四川大学华西医院接受PCI的高危患者。参与者将按1:1的比例随机分配到6个月的DTx-HBCR组（干预组）或6个月的常规护理组（对照组）。干预期结束后，两组将在无积极干预的情况下再进行6个月的随访观察。结局评估将在基线以及随机分组后的3、6和12个月进行。主要结局是6个月时通过6分钟步行试验评估的两组间功能能力差异。关键次要结局包括心血管健康指标（即吸烟状况、血压、糖化血红蛋白、血脂谱、体重指数和身体活动）的变化、健康相关生活质量、心理健康以及对循证心脏保护药物的依从性。所有分析将按照意向性分析原则进行。
DTx-HBCR试验是一项新颖的随机对照临床研究，旨在评估集成DTx的HBCR计划对改善PCI后高危患者功能能力的疗效。这种集成DTx的干预措施有可能改善这一高危人群的心血管健康结局。
NCT06542575（ClinicalTrials.gov）。
