Validation of the 1-minute Sit to Stand Test (1MSTS) for Assessment of Breathlessness at Exertion in Individuals With Chronic Disease in Out-patient Care
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Breathlessness intensity on BorgCR10 immediately after the 1MSTS
研究概览
简要总结
Breathlessness is a common symptom in people with chronic lung and heart diseases. It can affect daily activities, quality of life, and overall health. Current questionnaires used to assess breathlessness depend on a person's memory of symptoms and may not accurately capture breathlessness during physical activity.
This study aims to evaluate whether the one-minute sit-to-stand test (1MSTS), a simple test that involves repeatedly standing up from and sitting down on a chair for one minute, can measure breathlessness during exercise. Adults with chronic obstructive pulmonary disease (COPD), asthma, interstitial lung disease (ILD) or heart failure (HF) will participate.
Participants will attend three study visits and complete exercise tests, including the 1MSTS, a six-minute walk test (6MWT), and cardiopulmonary exercise testing (CPET). The study will assess how well breathlessness measured during the 1MSTS test reflects breathlessness during other established exercise tests, and whether the test provides reliable and responsive measurements over time.
The results may help establish the 1MSTS as a practical and easy-to-use tool for assessing exertional breathlessness in both clinical practice and research.
详细描述
Chronic breathlessness is a common and burdensome symptom among people with chronic respiratory and cardiovascular diseases. Accurate assessment of exertional breathlessness is important for clinical evaluation, monitoring of disease progression, and evaluation of treatment effects. Commonly used instruments, including symptom questionnaires, primarily rely on retrospective recall and may not adequately capture breathlessness experienced during physical activity.
The one-minute sit-to-stand test (1MSTS) is a simple, low-cost functional exercise test that can be performed in a wide range of healthcare settings. Although the test is increasingly used to assess functional capacity in patients with chronic disease, its role as a tool for assessing exertional breathlessness has not been fully established.
This prospective multicenter validation study aims to evaluate the measurement properties of breathlessness assessed during the 1MSTS in adults with chronic obstructive pulmonary disease (COPD), asthma, interstitial lung disease (ILD), and heart failure (HF). Participants will undergo repeated assessments using the 1MSTS and established exercise tests, including cardiopulmonary exercise testing (CPET) and the six-minute walk test (6MWT). Breathlessness will be assessed during exercise using standardised rating scales, and physiological responses will be recorded using conventional and sensor-based methods.
The study will examine the validity, reliability, and responsiveness of breathlessness measurements obtained during the 1MSTS. Findings from this study may support the use of the 1MSTS as a practical and accessible tool for identifying and monitoring exertional breathlessness in both clinical practice and research settings.
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
- 否
入选标准
- •Have a physician diagnosis of COPD/ILD/Asthma/HF.
- •The participant has given written consent to participate in the study
- •Age 18 years or older
- •Able to cycle
- •Able to use the legs and stand up from sitting without risk of falling
- •Able to understand and speak Swedish to participate in the study procedures, as judged by the staff.
排除标准
- •Resting peripheral oxygen saturation (SpO2) < 92%
- •hospitalisation or clinical instability during the last four weeks
- •Treatment with supplementary oxygen at rest or during exercise
- •contraindication to exercise testing in accordance with clinical practice guidelines
- •expected survival shorter than six months as judged by the Staff
- •medical conditions including acute coronary artery disease, neuromuscular disease or severe psychiatric illness.
研究组 & 干预措施
COPD
Individuals with COPD diagnosis
干预措施: 1MSTS (Diagnostic Test)
Heart Failure
Individuals with Heart Failure Diagnosis
干预措施: 1MSTS (Diagnostic Test)
ILD
Individuals with ILD diagnosis
干预措施: 1MSTS (Diagnostic Test)
Asthma
Individuals with Asthma diagnosis
干预措施: 1MSTS (Diagnostic Test)
结局指标
主要结局
Breathlessness intensity on BorgCR10 immediately after the 1MSTS
时间窗: Baseline (visit 1)
Breathlessness intensity will be assessed immediately after completion of the 1MSTS using the Borg CR10 scale (range 0-10; higher scores indicate higher intensity of breathlessness). We will evaluate construct validity by comparing breathlessness intensity (Borg CR10) at peak exercise with CPET, the 6MWT, and self-reported breathlessness on the mMRC and disease-specific questionnaires.
Test-retest reliability of breathlessness intensity measured using BorgCR10 immediately after the 1MSTS
时间窗: Baseline (two 1MSTS assessments performed during Visit 1)
Reproducibility of Borg CR10 breathlessness ratings (range 0-10; higher scores indicate higher intensity of breathlessness) obtained during repeated 1MSTS assessments.
Responsiveness of breathlessness intensity measured using the Borg CR10 immediately after the 1MSTS.
时间窗: Baseline to final follow-up visit.
Change in Borg CR10 breathlessness ratings (range 0-10; higher scores indicate higher intensity of breathlessness) immediately after 1MSTS between baseline and follow-up visits.
次要结局
- Diagnostic Accuracy of the 1MSTS for Identifying Abnormal Breathlessness(Baseline)
- Threshold Values for Pathological Breathlessness(Baseline)
- Wearable Sensor Performance Metrics(Baseline)
- Feasibility of the 1MSTS in Outpatient Care(Baseline)
- Prognostic Value of the 1MSTS(Baseline up to 10 years)
研究者
Jacob Sandberg
Postdoctoral Researcher
Blekinge Institute of Technology