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临床试验/NCT02708719
NCT02708719已完成不适用

Development of a Minimal Important Difference for the 1-minute Sit-to-stand Test

Schön Klinik Berchtesgadener Land1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2016年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
105
试验地点
1
主要终点
MID of the 1-minute-STST

研究概览

简要总结

The purpose of this study is to determine the minimal important difference (MID) for the 1-minute-sit-to-stand-test (STST) with an anchor-based method.

详细描述

In this study we develop the minimal important difference for the 1-minute sit-to-stand-test (STST) with an anchor-based method.

First step of this study is to find out the differences in the number of repetitions during 1-minute STST, 6-minute walk distance and health-related quality of life from pre to post inpatient pulmonary Rehabilitation program (3 weeks Duration) in the Schoen-Klinik Berchtesgadener Land.

In Addition, Balance tests on the Leonardo-Mechanograph will be performed and the Hospital Anxiety and Depression Scale (HADS) and Chronic Respiratory Questionnaire (CRQ) will be assessed.

For the second step we will use an anchor-based approach to estimate the MID of the STST. 6MWD and CRQ are used as anchors for which the MID has been established before.

研究设计

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

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Patients with COPD (GOLD-Stage II to IV)
  • •Ability to stand-up and walk
  • •written informed consent

排除标准

  • •orthopaedic or other comorbidities that prevent patients from performing the STST, 6MWT or exercise Training
  • •acute exacerbation
  • •heart failure, acute coronary syndrome

研究组 & 干预措施

Pulmonary rehabilitation

Other

multimodal pulmonary Rehabilitation program (3 weeks Duration)

干预措施: Pulmonary rehabilitation (Procedure)

结局指标

主要结局

MID of the 1-minute-STST

时间窗: 21 days

Change of maximum 1-minute sit-to-stand repititions

次要结局

  • 6-minute-walk distance(21 days)
  • CRQ Score(21 days)

研究者

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

Klaus Kenn

Prof. Dr. Klaus Kenn

Schön Klinik Berchtesgadener Land

研究点 (1)

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