About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
1MSTS
Diagnostic testThe 1-minute Sit-to-Stand Test
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
Secondary outcomes
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.
Threshold Values for Pathological Breathlessness
Identification of clinically relevant 1MSTS breathlessness thresholds associated with abnormal exercise responses.
Wearable Sensor Performance Metrics
Assessment of wearable sensor-derived measures of sit-to-stand performance and their association with breathlessness severity and exercise capacity.
Feasibility of the 1MSTS in Outpatient Care
Assessment of test completion, safety, participant acceptability and practicality of the 1MSTS.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Jacob Sandberg
Lead sponsor
Blekinge Institute of Technology
Sponsor institution
Lund University
Collaborator
This trial is not recruiting at the moment. You can still explore other options: