Blekinge Institute of Technology
Karlskrona, Blekinge County, 37142, Sweden
NCT Number: NCT07836764
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Karlskrona, Blekinge County, 37142, Sweden
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The 1-minute Sit-to-Stand Test
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline
Comparison of the ability of the 1MSTS, mMRC, and disease-specific questionnaires to identify abnormal exertional breathlessness using CPET and the 6MWT as reference measures. Sensitivity, specificity, and discrimination performance will be evaluated.
Time frame: Baseline
Identification of clinically relevant 1MSTS breathlessness thresholds associated with abnormal exercise responses.
Time frame: Baseline
Assessment of wearable sensor-derived measures of sit-to-stand performance and their association with breathlessness severity and exercise capacity.
Time frame: Baseline
Assessment of test completion, safety, participant acceptability and practicality of the 1MSTS.
Time frame: Baseline up to 10 years
Association between 1MSTS-derived breathlessness measures and subsequent clinical outcomes
Contact information is provided by the study sponsor or research team.
Jacob Sandberg
Other
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
Acronym: V1BE
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