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临床试验/NCT04094636
NCT04094636Unknown不适用

Physical Training During Hospital Admission With Community-Acquired Pneumonia

Nordsjaellands Hospital2 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
210
试验地点
2
主要终点
Length of hospital stay

研究概览

简要总结

The purpose of this study is to assess the effect of standard usual care combined with daily supervised physical training during hospitalization with community-acquired pneumonia (CAP) compared to standard usual care alnone.

详细描述

Community-acuired pneumonia (CAP) is a leading cause of hospitalization worldwide. Despite increased focus on mobilization, hospitalization is associated with bed rest. Bed rest with low levels of physical activity leads to functional deline as well as increased risk of complications.

This study is a randomized controlled trial, which investigates the effect of standard usual care combined with daily supervised physical training in patients hospitalized with CAP compared to standard usual care alone.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients 18 years of age or older admitted to hospital with CAP defined as a new infiltrate on chest X-ray/CT and minimum one of the following symptoms: temperature <35˚C or ≥38˚C, cough, pleuritic chest pain, dyspnea, or focal chest signs on auscultation.
  • Patients should have an expected admission length of ≥72 hours.
  • Patients should be able to move their legs.

排除标准

  • Patients unable to give written consent.
  • Hospital admission within the last 14 days.
  • Severe immunosuppression (cancer chemotherapy ≤28 days, neutropenia ≤1000 cells/μL, ≥20 mg prednisolone-equivalent/day >14 days or other immunosuppressive drugs, HIV infection, former transplant).

结局指标

主要结局

Length of hospital stay

时间窗: From admission until discharge (an average of 5 days)

Number of stays in hospital

次要结局

  • Readmissions Number of readmissions(3-months from discharge)
  • Mortality(6-months from discharge)
  • Changes in total lean mass(Day 1, day 5, discharge, 1- and 3-months from discharge)
  • Changes in total fat mass(Day 1, day 5, discharge, 1- and 3-months from discharge)
  • Changes in total fat-free mass(Day 1, day 5, discharge, 1- and 3-months from discharge)
  • Health-related quality of life(Day 1, discharge, 1-, 3- and 6-months from discharge)
  • Activities of daily living(Day 1, discharge, 1 month from discharge and 3 months from discharge)
  • Muscle strength(At day 1, day 5, discharge, 1- and 3-months after discharge)
  • Functional ability(Day 1, day 5, discharge, 1- and 3-months after discharge)
  • Systemic inflammation(Daily during admission (day 0 to 5), 1- and 3-months after discharge)
  • Physical activity monitoring(During admission (up to 7 days), 7 days from discharge, 7 days from 1- and 3 months follow-up)

研究者

发起方
Nordsjaellands Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Camilla Koch Rysoe

Principal investigator, MSc

Nordsjaellands Hospital

研究点 (2)

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