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

NCT07836764 | Not Yet Recruiting

• 3 other identifiers: 2026-02720-012025-077612025
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline to final follow-up visit.

Secondary Outcomes (5)

• Diagnostic Accuracy of the 1MSTS for Identifying Abnormal Breathlessness

  Baseline

• Threshold Values for Pathological Breathlessness

  Baseline

• Wearable Sensor Performance Metrics

  Baseline

• Feasibility of the 1MSTS in Outpatient Care

  Baseline

• Prognostic Value of the 1MSTS

  Baseline up to 10 years

Study Arms (4)

COPD

Individuals with COPD diagnosis

Diagnostic Test: 1MSTS

Heart Failure

Individuals with Heart Failure Diagnosis

Diagnostic Test: 1MSTS

ILD

Individuals with ILD diagnosis

Diagnostic Test: 1MSTS

Asthma

Individuals with Asthma diagnosis

Diagnostic Test: 1MSTS

Interventions

1MSTS DIAGNOSTIC_TEST

The 1-minute Sit-to-Stand Test

Asthma; COPD; Heart Failure; ILD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jacob Sandberg: lead
• Lund University: collaborator

Study Sites (1)

Blekinge Institute of Technology

Karlskrona, Blekinge County, 37142, Sweden

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma; Disease; Lung Diseases, Interstitial; Dyspnea; Heart Failure

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Jacob Sandberg, M.D, PhD

CONTACT

+46734471519; jacob.sandberg@bth.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Postdoctoral Researcher

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 23, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 6 months after publication of the primary results and ending 5 years after publication.
• Access Criteria: De-identified individual participant data may be made available to qualified researchers upon reasonable request. Access will require approval of the proposed research project and may be subject to a data sharing agreement. Data sharing must comply with applicable ethical approvals, Swedish data protection legislation, and institutional policies.

Locations

SE (1)