An observational study in COPD (Chronic Obstructive Pulmonary Disease), Asthma (Diagnosis) and Interstitial Lung Disease (ILD), sponsored by Jacob Sandberg. Not yet recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Jacob Sandberg · Observational
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.
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.
Adults with chronic cardiorespiratory disease will be recruited from outpatient and primary care clinics. The study population will include individuals with COPD, asthma, ILD, or HF who are able to perform exercise testing and attend study visits.
Exclusion Criteria:
Individuals with COPD diagnosis
Diagnostic Test: 1MSTS
Individuals with Heart Failure Diagnosis
Diagnostic Test: 1MSTS
Individuals with ILD diagnosis
Diagnostic Test: 1MSTS
Individuals with Asthma diagnosis
Diagnostic Test: 1MSTS
The 1-minute Sit-to-Stand Test
Breathlessness intensity on BorgCR10 immediately after the 1MSTS
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 (visit 1)
Test-retest reliability of breathlessness intensity measured using BorgCR10 immediately after the 1MSTS
Reproducibility of Borg CR10 breathlessness ratings (range 0-10; higher scores indicate higher intensity of breathlessness) obtained during repeated 1MSTS assessments.
Time frame: Baseline (two 1MSTS assessments performed during Visit 1)
Responsiveness of breathlessness intensity measured using the Borg CR10 immediately after the 1MSTS.
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 to final follow-up visit.
Diagnostic Accuracy of the 1MSTS for Identifying Abnormal Breathlessness
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
Threshold Values for Pathological Breathlessness
Identification of clinically relevant 1MSTS breathlessness thresholds associated with abnormal exercise responses.
Time frame: Baseline
Wearable Sensor Performance Metrics
Assessment of wearable sensor-derived measures of sit-to-stand performance and their association with breathlessness severity and exercise capacity.
Time frame: Baseline
Feasibility of the 1MSTS in Outpatient Care
Assessment of test completion, safety, participant acceptability and practicality of the 1MSTS.
Time frame: Baseline
Prognostic Value of the 1MSTS
Association between 1MSTS-derived breathlessness measures and subsequent clinical outcomes
Time frame: Baseline up to 10 years
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — De-identified individual participant data underlying the reported results will be available upon reasonable request to the study investigators, subject to applicable ethical approvals, data protection regulations, and institutional requirements.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive→