A Prospective Trial to Evaluate the Utility of Focused Frailty Interventions on Patients Undergoing Evaluation for Left Ventricular Assist Device (LVAD) Placement
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 试验地点
- 2
- 主要终点
- Change in frailty marker gait speed
研究概览
简要总结
This study is a pilot study evaluating the feasibility and early efficacy of cardiac rehabilitation to improve frailty and symptoms in patients with advanced heart failure (NYHA class III-IV), who are being considered for LVAD therapy.
详细描述
Frailty in patients with advanced heart failure is not thoroughly described, but in those studies that assessed frailty, it was a common phenomenon. Furthermore, some data suggest an association between pre-LVAD implant frailty and post-implant complications and survival. Interventions for frailty have been utilized in various populations, including the elderly frail and the frail from cardiovascular causes. These interventions target physical strengthening and endurance and have been shown on occasion to improve functional outcomes. The current study, a pilot study, seeks to assess frailty in a prospective cohort of patients being evaluated in Heart Failure Clinic for consideration of LVAD implantation due to NYHA class III-IV dyspnea and enroll these patients in a six-week focused cardiac rehabilitation protocol aimed at improving frailty and functional independence. The primary endpoint of the study is improvement in frailty markers at the end (gait speed, handgrip strength), and secondary endpoints include improvement in the indices of quality of life and symptomatology via validated questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Candidate for a Left Ventricular Assist Device (LVAD)
- •Advanced Heart Failure as determined by New York Heart Association classification III or IV
排除标准
- •Unable to perform physical activities required by protocol due to anatomic or musculoskeletal comorbidities
- •Physical activity is contraindicated
研究组 & 干预措施
Cardiac Rehabilitation
Strength Training for Frailty:
All patients enrolled will be enrolled in 6 weeks of cardiac rehabilitation for the pilot study.
干预措施: Strength Training for Frailty (Other)
结局指标
主要结局
Change in frailty marker gait speed
时间窗: Baseline, 6 weeks
Frailty is assessed by the strength of a participant's gait speed, measured using a commercial device.
Change in frailty marker handgrip strength
时间窗: Baseline, 6 weeks
Frailty is assessed by the strength of a participant's handgrip, measured using a commercial device.
次要结局
- Change in New York Heart Association (NYHA) classification(Baseline, 6 weeks)
- Change in KCCQ score(Baseline, 6 weeks)
- Change in Minnesota Living with Heart Failure (MLHF) score(Baseline, 6 weeks)
