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Starting soon Observational

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

NCT07836764 · tracked via the Priya Life Science Sweden tracker
Sponsor
Jacob Sandberg
Phase
Observational
Started
2026-11-01
Last updated
2026-09-23

Condition(s) studied

COPD (Chronic Obstructive Pulmonary Disease)Asthma (Diagnosis)Interstitial Lung Disease (ILD)

Investigational drug(s) / intervention(s)

1MSTS

1MSTS: The 1-minute Sit-to-Stand Test

Study 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.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Breathlessness intensity on BorgCR10 immediately after the 1MSTS — 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 — 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. — 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.

Trial sites (1)

FacilityCityRegionStatus
Blekinge Institute of Technology Karlskrona Blekinge County
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07836764 on ClinicalTrials.gov ↗ ← All trials in Sweden