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临床试验/NCT07193173
NCT07193173进行中(未招募)不适用

Is the Two-minute Step Test an Alternative to the Six-minute Walk Test in Pulmonary Hypertension?: Validation of 2 Minute Step Test

Saglik Bilimleri Universitesi2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2025年9月15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
35
试验地点
2
主要终点
2 Minute Step Test

研究概览

简要总结

The aim of this observational study is to evaluate the validity of the 2-minute step test in assessing functional capacity in pulmonary hypertension.

详细描述

Pulmonary hypertension (PH) is a progressive cardiopulmonary disorder characterized by elevated pulmonary artery pressure, which can lead to right ventricular dysfunction and ultimately heart failure. Right heart catheterization is used to diagnose the disease, and individuals are diagnosed with PH when the mean pulmonary artery pressure is 20 mmHg or higher. Exercise intolerance is one of the key features of PH. The 6-minute walk test (6MWT) is the most commonly used test method in PH centers for assessing functional exercise capacity and plays a key role in the evaluation and management of PH. However, it has significant limitations in this context. Although the 6MWT is currently recommended for assessing functional exercise capacity independently of the environment, it is not feasible in most clinics, homes, and medical offices due to the requirement for a 30-meter-long corridor. The long-standing need for a practical and effective exercise assessment tool that is independent of physical space highlights the need for new methods to assess functional capacity. The 2-minute walk test was developed by Rikli and Jones in 1999.

The test requires individuals to stand and step in place as quickly as possible for 2 minutes while raising their knees to a height between the patella and iliac crest. Performance in the test is defined as the number of steps taken on the right side within 2 minutes, reaching the criterion height. The validity and reliability of the 2-minute step test have previously been investigated in patients with back pain, cardiopulmonary rehabilitation patients, and hypertensive geriatric patients.

The aim of this study is to evaluate the validity of the 2-minute step test in assessing functional capacity in PH.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

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

入选标准

  • •Being diagnosed with pulmonary hypertension (PH)
  • •Being 18 years of age or older
  • •Agreeing to participate in the study

排除标准

  • •Acute decompensated heart failure
  • •Orthopedic or neurological disorders that prevent the test from being performed
  • •Patients who have difficulty understanding the instructions given

结局指标

主要结局

2 Minute Step Test

时间窗: 2 minutes

The 2-minute step test (2MST) is a test used to assess functional capacity. The maximum number of knee lifts the individual can perform within 2 minutes will be counted, with the minimum height occurring at the midpoint between the patella and the anterior superior iliac spine (during steady walking, without changing position). The test will be performed with a mobile ergospirometer (K5, Cosmed, Italy). Oxygen consumption, task-based heart rate, and ventilation obtained during the 2MST will be recorded. In addition, the Borg dyspnea and fatigue scale will also be included in the assessment.

次要结局

  • Functional capacity(6 minutes)
  • mMRC Dyspnea Scale(5 minutes)

研究者

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

Pinar BASTURK MERC

Principal Investigator, Physiotherapist, PhD

Saglik Bilimleri Universitesi

研究点 (2)

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