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临床试验/NCT05886842
NCT05886842已完成不适用

Reliability of 30 Seconds Sit-to-stand and Timed Up and Go in Adults With Long Covid

European University Cyprus1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2022年12月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
1
主要终点
Reliability of 30 seconds Sit to stand

研究概览

简要总结

The goal of this study is to test the reliability (with a test-retest process) of 30 seconds Sit to Stand and Timed Up and Go in an adult population with long-covid, hospitalised in a rehabilitation center.

详细描述

Since December 2019, Covid-19 has affected millions of people worldwide, leaving many of them with symptoms such as fatigue, (muscle) weakness and dyspnoea, even months after their infection (long covid). Rehabilitation centers were established to aid this new group of patients. This study's aim is to test the reliability of 2 outcome measures for patients with long covid. 30 seconds Sit-To-Stand and Timed Up And Go tests are not specific to a disease but they evaluate functionality, mobility and endurance. They are easy to perform in a clinical setting as they do not require specific equipment. The reliability of the above tests has yet to be established in people with long covid.

A sample size of 19 people will be used. A difference in reliability of 0.9 and 0.7 at 80% power and a 5% level of significance using two ratings was set. Based on two testing sessions, an x value of 0.05, and a power of 0.80, a minimal sample size of 19 patients was identified (Karagiannis et al., 2020).

19 patients with long covid from the rehabilitation center will take both tests in a single day and 3 days later they will take the tests again with no physical therapy intervention in between the measurements.

For the statistical analysis, ICC (Intra-class correlation coefficients), SEM (standard error of measurement) and Bland-Altman plot will be used. These tests evaluate test-retest reliability, through the identification of the agreement of patient's scores between the 2 measurements and they evaluate the measurement precision (Savva et al, 2014).

研究设计

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

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

  • Adults who were infected with COVID-19 virus in the last 6 months and were diagnosed with long-covid
  • Patients must be willing to give written consent for participation in the study
  • Negative rapid test for COVID-19

排除标准

  • People under 18 years of age
  • Significant cognitive and psychiatric impairments (inability to follow simple commands or give consent)
  • Refuse to give consent

结局指标

主要结局

Reliability of 30 seconds Sit to stand

时间窗: Two occasions within approximately three days to establish intra rater reliability

Test-retest that assess the reliability of 30 seconds Sit to Stand

Reliability of Timed Up and Go

时间窗: Two occasions within approximately three days to establish intra rater reliability

Test-retest that assess the reliability of Timed Up and Go

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marina Kloni

Marina Eleni Kloni, BSc, MSc, MA

European University Cyprus

研究点 (1)

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