跳至主要内容
临床试验/NCT05726565
NCT05726565已完成不适用

Impact of Cardiac Rehabilitation on Acute Heart Failure Patients With Cognitive Impairment

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 247 人开始时间: 2015年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
247
试验地点
1
主要终点
composite of all-cause mortality or HF hospitalization

研究概览

简要总结

In heart failure patients, neuropsychological disorders have been prospectively linked to frequent hospitalizations, recurrent cardiac events, and mortality. Cognitive dysfunction is also a frequent comorbidity in heart failure (HF) patients. The benefit of cardiac rehabilitation between patients with cognitive dysfunction and patients without cognitive dysfunction is unknown. Investigators hypothesize that patients with cognitive dysfunction benefit more from cardiac rehabilitation programs than patients without cognitive dysfunction.

详细描述

Investigators retrospectively reviewed HF patients discharged from acute HF hospitalizations between March 2015 and May 2021 at the heart failure center, Kaohsiung Chang Gung Memorial Hospital. Cognitive function was assessed with the Luria-Nebraska Neuropsychological Battery-Screening test (LNNB-S) Chinese version by an experienced psychologist. Participants may have cognitive impairment when their LNNB-S >=10. A heart failure disease management program was delivered to all patients before discharge, including an HF specialist nurse education program, dietitian consultation, physiatrist consultation, and psychologist consultation and assessment. Participants were advised to receive phase II cardiac rehabilitation (CR) after the cardiopulmonary exercise test (CPET) within one month. Moderate continuous aerobic exercise training was prescribed individually according to the CPET result. Participants who received at least one exercise session of phase II CR were considered as receiving CR. Other participants were considered non-receiving CR. Kaplan-Meier curves and log-rank test were constructed to compare the composite endpoint and all-causes mortality in four groups (Group a: Candidates without cognitive impairment and receiving CR. Group b: Candidates without cognitive impairment and not-receiving CR. Group c: Candidates with cognitive impairment and receiving CR. Group d: Candidates with cognitive impairment and not-receiving CR.)

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • acute HF patients with reduced ejection fraction (left ventricular ejection fraction, LVEF <=40%) and discharged alive from the hospital.
  • Completed cognitive and psychological functional assessment.
  • Aged >= 20 years of age, male or female.
  • Received heart failure disease management coordinated by an HF specialist nurse as described before.

排除标准

  • Estimated survival time < 6 months.
  • Long-term bedridden for more than 3 months.
  • Terminal heart status.
  • Cannot cooperate with all functional studies.

结局指标

主要结局

composite of all-cause mortality or HF hospitalization

时间窗: March, 2015 ~ May, 2021

Number of participants that had an occurrence of the mortality which is defined as all-cause mortality or occurrence of HF hospitalization

次要结局

  • all-cause mortality(March, 2015 ~ May, 2021)
  • recurrent HF hospitalization(March, 2015 ~ May, 2021)
  • Change From Baseline to Month 6 and Month 12 for the Kansas City Cardiomyopathy Questionnaire 12 (KCCQ 12) Clinical Summary Score(March, 2015 ~ May, 2021)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验