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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJacob Sandberg

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 1MSTS

    Diagnostic test

    The 1-minute Sit-to-Stand Test

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: COPD1 intervention
Group B: Heart Failure1 intervention
Group C: ILD1 intervention
Group D: Asthma1 intervention

Trial outcomes

Primary outcomes

1

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)
2

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)
3

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.

Secondary outcomes

1

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
2

Threshold Values for Pathological Breathlessness

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

Time frame
Baseline
3

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
4

Feasibility of the 1MSTS in Outpatient Care

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

Time frame
Baseline

Other outcomes

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: