Department of Nursing, Zhongshan Hospital, Fudan University, Shanghai, China.
Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai, China.
BMJ Open. 2024 Mar 7;14(3):e080042. doi: 10.1136/bmjopen-2023-080042.
Transcatheter aortic valve replacement (TAVR) is a standard treatment for aortic stenosis, particularly in older adults. Reduced exercise capacity and frailty significantly impact outcomes in TAVR patients, yet current management lacks strategies to address these issues. This study aims to assess the effectiveness of home-based mobile-guided exercise-based cardiac rehabilitation in TAVR patients, led by a multidisciplinary team with clear progression milestones.
The study involves 90 patients aged 60-89 in a single centre who will be randomised to a 3-month novel multidomain exercise intervention or routine care. Outcome assessors will be blinded towards group allocation. The primary outcome is the 6-min walk distance at month 3. The secondary outcomes include the 6-min walk distance at month 6, physical function measured by total Short Physical Performance Battery score and exercise adherence measured by the Exercise Adherence Rating Scale at months 3 and 6. Additional outcome measures, including rehospitalisations, death, handgrip strength, frailty (Fried Criteria and Essential Toolset), cognitive function (Mini-Mental State Examination), quality of life (EuroQol 5-Dimension 5-Level), nutritional status (Mini-Nutritional Assessment), anxiety (General Anxiety Disorder-7), depression (Geriatric Depression Scale), sleep (Pittsburgh Sleep Quality Index), functional capacity (Duke Activity Status Index), clinical indices (body mass index, symptoms, signs, left ventricular ejection fraction (LVEF), N-Terminal Pro-Brain Natriuretic Peptide, etc) and social support (Lubben Social Network Scale-6), along with comprehensive cost analysis, enhance the study's significance. The study's findings hold crucial implications for crafting an effective exercise-focused cardiac rehabilitation strategy for TAVR patients. Community implementation not only deepens understanding but also fosters the potential integration of exercise-based cardiac rehabilitation into self-care, promising enhanced patient adherence and overall cardiovascular health management.
Ethical approval was obtained from the Zhongshan Hospital, Fudan University Ethics Committee (B2022-062R). Results will be disseminated to local stakeholders and the research community through publications and conferences.
NCT05989594.
经导管主动脉瓣置换术（TAVR）是治疗主动脉瓣狭窄的标准方法，尤其适用于老年患者。运动能力下降和虚弱显著影响 TAVR 患者的预后，但目前的治疗方法缺乏解决这些问题的策略。本研究旨在评估由多学科团队领导、具有明确进展里程碑的基于家庭的移动指导下心脏康复对 TAVR 患者的有效性。
该研究纳入了来自单一中心的 90 名年龄在 60-89 岁的患者，他们将被随机分配到为期 3 个月的新型多领域运动干预组或常规护理组。结果评估者将对分组情况进行盲法评估。主要结局指标是第 3 个月时的 6 分钟步行距离。次要结局指标包括第 6 个月时的 6 分钟步行距离、总短体生理性能电池评分测量的身体功能以及第 3 个月和第 6 个月时的运动依从性测量的运动依从性评分量表。其他结局指标包括再住院、死亡、握力、虚弱（Fried 标准和基本工具集）、认知功能（简易精神状态检查）、生活质量（EuroQol 5 维 5 级）、营养状况（迷你营养评估）、焦虑（广泛性焦虑障碍 7 项）、抑郁（老年抑郁量表）、睡眠（匹兹堡睡眠质量指数）、功能能力（杜克活动状态指数）、临床指标（体重指数、症状、体征、左心室射血分数（LVEF）、N 端脑利钠肽前体等）和社会支持（Lubben 社会网络量表-6），同时进行全面的成本分析，增强了研究的意义。该研究的结果对制定有效的以运动为重点的 TAVR 患者心脏康复策略具有重要意义。社区实施不仅加深了理解，还促进了基于运动的心脏康复纳入自我护理，有望提高患者的依从性和整体心血管健康管理。
该研究已获得复旦大学中山医院伦理委员会的批准（B2022-062R）。结果将通过出版物和会议向当地利益相关者和研究界传播。
NCT05989594。
