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临床试验/NCT07357805
NCT07357805已完成不适用

Validity and Reliability of the 6-minute Stepper Test in Patients With Asthma

Gazi University1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2017年6月24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
41
试验地点
1
主要终点
6-minute Stepper Test

研究概览

简要总结

Asthma is a chronic respiratory disease that can negatively affect exercise tolerance and functional capacity due to airway inflammation, variable airflow limitation, and symptom-related activity avoidance. Reduced physical activity levels and exercise-induced symptoms often lead to physical deconditioning, which may further impair cardiorespiratory fitness and daily functional performance in individuals with asthma. There is substantial evidence supporting the use of cardiopulmonary exercise testing (CPET) for the evaluation of exercise capacity in patients with respiratory diseases. However, it is not known whether the use of the 6-minute stepper test (6-MST) is a valid and reliable test for the assessment of functional exercise capacity in patients with asthma. The aim of this study is to investigate the reliability and validity of the 6-MST for evaluating functional exercise capacity in individuals with asthma.

详细描述

Asthma is a chronic inflammatory disorder of the airways, characterized by variable airflow obstruction, bronchial hyperresponsiveness, and respiratory symptoms including wheezing, dyspnea, and chest tightness. Although pharmacological treatment remains the cornerstone of asthma management, the evaluation of functional capacity and exercise tolerance has become increasingly important, particularly in individuals with moderate to severe asthma.Cardiopulmonary exercise testing (CPET) is regarded as the gold standard for the comprehensive assessment of cardiovascular, ventilatory, and musculoskeletal system performance through a multidimensional approach. It provides detailed measurements of oxygen uptake (VO₂), carbon dioxide production (VCO₂), ventilatory thresholds, heart rate responses, and subjective symptoms such as dyspnea and fatigue related to musculoskeletal performance. Nevertheless, CPET requires specialized equipment and trained personnel and may not be feasible in all clinical settings, particularly for routine follow-up or in environments with limited technical resources. In contrast, the 6-minute stepper test (6-MST) has gained attention as a practical, low-cost alternative that requires minimal equipment for the assessment of functional capacity. The 6-MST consists of stepping up and down on a fixed-height platform for six minutes, with the total number of steps used as an indicator of endurance. Owing to its minimal space and equipment requirements, the test is well suited for outpatient settings, home-based rehabilitation programs, and telerehabilitation applications. However, it is not known whether the 6 MST is valid and reliable in assessing functional exercise capacity in patients with asthma. Therefore, the aim is to examine the validity and reliability of the 6 MST in patients with asthma. The study was planned as a retrospective study. All patients' clinical data, maximal exercise capacity, functional exercise capacity pulmonary function, dyspnea, and quality of life were assessed.The results will be analysed and interpreted using appropriate statistical analysis methods.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 18 years
  • Diagnosis of asthma established according to the Global Initiative for Asthma (GINA) guidelines
  • Use of standard asthma pharmacological treatment, including: inhaled corticosteroids (ICS), low-dose ICS in combination with long-acting β₂-agonists (LABA), or mild to high doses of ICS in combination with LABA
  • Asthma Control Test (ACT) score ≥ 20
  • Smoking history of ≤ 10 pack-years

排除标准

  • Presence of a recent respiratory tract infection
  • Use of systemic corticosteroids within the past year
  • History of smoking
  • Previous or current malignancy
  • Presence of any medical condition that could affect functional exercise capacity
  • Presence of any psychiatric disorder

研究组 & 干预措施

Patients with asthma

All patients' clinical data, maximal exercise capacity, functional exercise capacity, pulmonary function, dyspnea, and quality of life were evaluated.

结局指标

主要结局

6-minute Stepper Test

时间窗: First day

The test was performed with a stepper device positioned 20 cm above the ground. Participants were instructed to perform stepping movements as rapidly and rhythmically as possible at a self-selected pace. Standardized verbal encouragement was provided at one-minute intervals throughout the test. Participants were advised that they were permitted to pause and rest during the test if they experienced symptoms severe enough to prevent continued stepping, and that all rest periods would be included in the total test duration. Total number of step were recorded.

Oxygen consumption (Cardiopulmonary Exercise Test)

时间窗: Second day

Oxygen consumption was measured with Cardiopulmonary Exercise Test. The CPET was performed using a gradually increasing workload protocol with breath-by-breath measurement on a treadmill.

次要结局

  • Pulmonary function (Forced vital capacity (FVC))(First day)
  • Pulmonary function (Forced expiratory volume in the first second (FEV1))(First day)
  • Pulmonary function (FEV1 / FVC)(First day)
  • Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))(First day)
  • Pulmonary function (Peak flow rate (PEF))(First day)
  • Dyspnea (Modified Borg Scale)(First day)
  • Dyspnea (Modified Medical Research Council Dyspnea Scale)(First day)
  • Disease-specific Quality of Life(First day)

研究者

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

Meral Boşnak Güçlü

Prof. Dr.

Gazi University

研究点 (1)

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