Prehabilitation to Improve Functional and Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Replacement: TAVR-FRAILTY Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Change in Score on short physical performance battery (SPPB) test
研究概览
简要总结
Transcatheter aortic valve replacement (TAVR) is a treatment alternative among high-risk elderly with aortic stenosis, however, mortality remains high. Fifty percent of patients undergoing TAVR exhibit frailty, a syndrome associated with poor survival. It is unknown whether interventions to improve frailty before TAVR (prehabilitation) will improve outcomes after TAVR. This study plans to evaluate whether simple cardiac exercise interventions to improve physical performance before TAVR improves outcomes after TAVR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility for TAVR
- •Able to exercise
- •Able to come for follow-up visits
- •Able to give informed consent
排除标准
- •New York Heart Association (NYHA) Class III/IV congestive heart failure (CHF)
- •Presyncope or syncope as presentation
- •Acute coronary syndrome
- •Unable to exercise
- •Sustained ventricular arrhythmia
- •Stroke with neurological deficit
- •Advanced Parkinson's
- •Participated in an exercise program
研究组 & 干预措施
Prehabilitation
Will receive 4 weeks of supervised exercised prescription before they undergo TAVR and will monitor and record, improvement if any, in the short-term physical performance battery score
干预措施: Prehabilitation (Other)
Usual care
Will receive usual care
干预措施: Usual Care (Other)
结局指标
主要结局
Change in Score on short physical performance battery (SPPB) test
时间窗: Baseline, approximately 1 year
次要结局
未报告次要终点