COPD (Chronic Obstructive Pulmonary Disease)V1BENCT07836764
Validation of 1 Minute Sit-to Stand Test for Assessment of Breathlessness at Exertion in Individuals With Chronic Lung Disease
An observational study of COPD (Chronic Obstructive Pulmonary Disease) and Asthma (Diagnosis), run by Jacob Sandberg at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease), Asthma (Diagnosis), Interstitial Lung Disease (ILD)
- What is being tested?
- 1MSTS
- How many people
- 120 participants
- Where
- 1 siteSweden
- Study dates
- 1 Nov 2026to Dec 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Blekinge Institute of Technology
Karlskrona, Blekinge County, 37142
Jacob Sandberg, M.D, PhD, +46734471519, jacob.sandberg@bth.se
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
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.
- Conditions
- COPD (Chronic Obstructive Pulmonary Disease), Asthma (Diagnosis), Interstitial Lung Disease (ILD)
- Being tested
- 1MSTS
- Keywords
- Breathlessness, Dyspnea, Exertional Breathlessness, One-Minute Sit-to Stand Test, COPD, Asthma, Interstitial Lung Disease, Heart Failure, Exercise testing, CPET, Six-Minute Walk Test, 6MWT, Functional Capacity, Validation Study, Sensor Technology, Wearable Sensors
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma, Disease, Lung Diseases, Interstitial, Dyspnea, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1MSTSDiagnostic test
The 1-minute Sit-to-Stand Test
| Study group | Role | What they receive |
|---|---|---|
| COPD | Individuals with COPD diagnosis Receives: Diagnostic Test: 1MSTS | |
| Heart Failure | Individuals with Heart Failure Diagnosis Receives: Diagnostic Test: 1MSTS | |
| ILD | Individuals with ILD diagnosis Receives: Diagnostic Test: 1MSTS | |
| Asthma | Individuals with Asthma diagnosis Receives: Diagnostic Test: 1MSTS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline to final follow-up visit.
Secondary outcomes (5)
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.
Measured: Baseline
Threshold Values for Pathological Breathlessness
Identification of clinically relevant 1MSTS breathlessness thresholds associated with abnormal exercise responses.
Measured: 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.
Measured: Baseline
Feasibility of the 1MSTS in Outpatient Care
Assessment of test completion, safety, participant acceptability and practicality of the 1MSTS.
Measured: Baseline
Prognostic Value of the 1MSTS
Association between 1MSTS-derived breathlessness measures and subsequent clinical outcomes
Measured: Baseline up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jacob Sandberg
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University
- Responsible party
- Sponsor-investigator, Jacob Sandberg, Blekinge Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836764
- Sponsor's protocol ID
- 2026-02720-01
- Other IDs
- 2025-07761, 2025
- Acronym
- V1BE
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.