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临床试验/NCT05852821
NCT05852821已完成不适用

The 5 Repetitions Sit-to-stand Test, Carried Out Remotely Via Videoconference, in Patients With COPD: Is There a Learning Effect?

Korian2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年4月18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
40
试验地点
2
主要终点
the variation in time of 5STS between first assay and fifth assay during the first visit (V1).

研究概览

简要总结

The purpose of this clinical study is to determine if a learning effect exists when the 5STS is assessed remotely via videoconference in patients with COPD.

详细描述

Pulmonary rehabilitation (PR) is an essential therapy for improving exercise tolerance and quality of life in patients with chronic respiratory disease. It is now available remotely thanks to advances in information and communication technologies. Pulmonary telerehabilitation facilitates care access for patients living far from specialized centers. It requires, for a complete and coherent transposition, to be able to evaluate the patients remotely in order to measure the evolution of their functional capacities and to ensure their follow-up. Among the tests already implemented at home and remotely via video-conference, the 5-repetition sit-to-stand test (5STS) is the most suitable. This test requires only a short time to perform, little space and no specific equipment. However, two major limits remain to be checked before being able to consider its remote and routine implementation. First of all, it is important to study its feasibility. Moreover, like other functional tests, it raises the question of a possible learning effect (LE). In the perspective of a current use of the 5STS remotely, it is therefore also essential to assess the existence of a potential LE which would condition the methods of administering the test and its interpretation.

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

  • Patients with a diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
  • Obtaining oral informed consent after a minimum reflection period of 24 hours
  • Patient with internet access at home and a tool allowing the realization of a videoconference (smartphone or computer)

排除标准

  • Patients who had a recent exacerbation (less than 4 weeks)
  • Patients physically unable to get up from a chair and sit down without help
  • Patients with significant and unstable cardiovascular disease
  • Any acute or chronic pathology (orthopedic, neurological, psychiatric or causing a major cognitive disorder) limiting the performance of a functional test
  • Inability or difficulty using digital tools
  • Subjects in a period of relative exclusion compared to another protocol
  • Adults protected by law or patient under guardianship or curatorship
  • Subjects deprived of liberty by a judicial or administrative decision
  • Current or planned pregnancy during the study period
  • Pregnant or breastfeeding women
  • Patients not affiliated to a French social security scheme or not benefiting from such a scheme

结局指标

主要结局

the variation in time of 5STS between first assay and fifth assay during the first visit (V1).

时间窗: 1 day

次要结局

  • the variation in time of 5STS between the first visit (V1) and the second visit (V2).(2 days)
  • the variation in time of 5STS between the second visit (V2) and the third visit (V3).(1 month)
  • The number of patients excluded because of the video-conference tool(through study completion, an average of 1 year)
  • Patient satisfaction(1 month)
  • the variation in time of 5STS between each trial at the first visit (V1).(1 day)
  • The number of tests not carried out(through study completion, an average of 1 year)
  • The reproducibility of the remote test(1 month)
  • The number of connection failures(through study completion, an average of 1 year)

研究者

发起方
Korian
申办方类型
Other
责任方
Sponsor

研究点 (2)

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