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NCT Number: NCT07836764

Validation of 1 Minute Sit-to Stand Test for Assessment of Breathlessness at Exertion in Individuals With Chronic Lung Disease

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

1MSTS

Diagnostic Test

The 1-minute Sit-to-Stand Test

Primary outcomes

  1. Breathlessness intensity on BorgCR10 immediately after the 1MSTS

    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.

  2. Test-retest reliability of breathlessness intensity measured using BorgCR10 immediately after the 1MSTS

    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.

  3. Responsiveness of breathlessness intensity measured using the Borg CR10 immediately after the 1MSTS.

    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.

Secondary outcomes

  1. Diagnostic Accuracy of the 1MSTS for Identifying Abnormal Breathlessness

    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.

  2. Threshold Values for Pathological Breathlessness

    Time frame: Baseline

    Identification of clinically relevant 1MSTS breathlessness thresholds associated with abnormal exercise responses.

  3. Wearable Sensor Performance Metrics

    Time frame: Baseline

    Assessment of wearable sensor-derived measures of sit-to-stand performance and their association with breathlessness severity and exercise capacity.

  4. Feasibility of the 1MSTS in Outpatient Care

    Time frame: Baseline

    Assessment of test completion, safety, participant acceptability and practicality of the 1MSTS.

  5. Prognostic Value of the 1MSTS

    Time frame: Baseline up to 10 years

    Association between 1MSTS-derived breathlessness measures and subsequent clinical outcomes

Study contacts

Contact information is provided by the study sponsor or research team.

Jacob Sandberg, M.D, PhD

CONTACT

[email protected]

+46734471519

Sponsors and collaborators

Lead sponsor

Jacob Sandberg

Other

Collaborators

  • Lund University

Registry information

Official study 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

Acronym: V1BE

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 23, 2026
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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