跳至主要内容
临床试验/NCT03132441
NCT03132441撤回不适用

A Prospective Trial to Evaluate the Utility of Focused Frailty Interventions on Patients Undergoing Evaluation for Left Ventricular Assist Device (LVAD) Placement

Mayo Clinic2 个研究点 分布在 1 个国家开始时间: 2017年4月最近更新:
适应症
干预措施

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

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

Experimental

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)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sudhir Kushwaha

MD

Mayo Clinic

研究点 (2)

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