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临床试验/NCT07122479
NCT07122479进行中(未招募)不适用

Prevention of Hospital Acquired Deconditioning in Hospitalized Acute Leukemia Patients

Northwell Health4 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年10月27日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
50
试验地点
4
主要终点
Assess Effectiveness of Prescribed Physical Exercise Program

研究概览

简要总结

This study aims to decrease the incidence of hospital acquired deconditioning (HAD) and to help standardize daily physical exercise monitoring in acute leukemia patients with anticipated prolonged duration of hospital stay. The investigators hypothesize that implementing a patient-reported adherence log of their recommended standard daily set of exercises will help reduce proportion of hospital acquired deconditioning in acute leukemia patients. The investigators also hypothesize that less adherent patients will have more inpatient hospital related events and decreased health related quality of life.

详细描述

Hospital-associated deconditioning (HAD), or post-hospital syndrome, describes the physical, cognitive, and functional decline that develops during hospitalization. Acute leukemia patients require inpatient chemotherapy treatments that often impose a minimal hospital stay of 21 days. While physical activity is recommended, its prescription and monitoring are not standardized, often leading to deconditioning developing before physical activity is urged.

This study aims to decrease the incidence of hospital acquired deconditioning (HAD) and to help standardize daily physical exercise monitoring in acute leukemia patients with anticipated prolonged duration of hospital stay. The investigators hypothesize that implementing a patient-reported adherence log of their recommended standard daily set of exercises will help reduce proportion of hospital acquired deconditioning in acute leukemia patients. The investigators also hypothesize that less adherent patients will have more inpatient hospital related events and decreased health related quality of life.

The intervention is a three-prong approach to reduce hospital acquired deconditioning in patients with anticipated prolonged length of stay for acute leukemia chemotherapy at North Shore University Hospital. The intervention includes 1) providing a set of daily physical exercises to patient according to their baseline performance status as assessed by physical therapist, 2) maintaining a patient-completed daily log of physical exercise adherence and 3) standardize the monitoring of physical exercise by the healthcare team by its inclusion in daily progress notes.

The results will assess the effectiveness of this intervention in reducing the occurrence proportion of HAD in the intervention group compared to historical controls. Additionally, the investigators will assess the correlation between patient reported adherence rate to the occurrence of hospital related events as well as its impact on health-related quality of life.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-99
  • Patient admitted to North Shore University Hospital on 7Monti floor
  • Diagnosis of acute leukemia (AML or ALL)
  • Admitted for treatment with remission inducing therapy either in frontline, relapsed or salvage setting with anticipated hospital length of stay of at least 10 days
  • ECOG 0-3 on day of induction.

排除标准

  • Patients admitted for >14 days prior to initiation of treatment.
  • Baseline altered mental status defined by Glasgow coma scale with score less than 15, that does not resolve within first 7 days of treatment as this would preclude participation in physical activity program.
  • Baseline disability that would prevent participation in physical activity program.
  • CML in acute blast phase.

结局指标

主要结局

Assess Effectiveness of Prescribed Physical Exercise Program

时间窗: 12 months

daily log of physical exercise adherence and 3) standardize the monitoring of physical exercise by the healthcare team by its inclusion in daily progress notes.

次要结局

  • assess the correlation between patient-reported adherence rate (%) of daily physical exercise(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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