[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657187":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":43,"studyPopulation":44,"armGroups":45,"interventions":63,"overallOfficials":39,"centralContacts":69,"locations":75,"responsibleParty":90,"collaborators":94,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":99,"sex":105,"minAge":106,"maxAge":39,"enrollmentInfo":107,"targetDuration":39,"studyType":110,"phases":39,"briefSummary":111,"conditions":112,"keywords":116,"overallStatus":130,"whyStopped":39,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},{"fullName":5,"class":6},"Blekinge Institute of Technology","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":21,"otherOutcomes":39},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"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)",{"measure":14,"description":15,"timeFrame":16},"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)",{"measure":18,"description":19,"timeFrame":20},"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.",[22,26,29,32,35],{"measure":23,"description":24,"timeFrame":25},"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.","Baseline",{"measure":27,"description":28,"timeFrame":25},"Threshold Values for Pathological Breathlessness","Identification of clinically relevant 1MSTS breathlessness thresholds associated with abnormal exercise responses.",{"measure":30,"description":31,"timeFrame":25},"Wearable Sensor Performance Metrics","Assessment of wearable sensor-derived measures of sit-to-stand performance and their association with breathlessness severity and exercise capacity.",{"measure":33,"description":34,"timeFrame":25},"Feasibility of the 1MSTS in Outpatient Care","Assessment of test completion, safety, participant acceptability and practicality of the 1MSTS.",{"measure":36,"description":37,"timeFrame":38},"Prognostic Value of the 1MSTS","Association between 1MSTS-derived breathlessness measures and subsequent clinical outcomes","Baseline up to 10 years",null,{"allocation":39,"interventionModel":39,"interventionModelDescription":39,"primaryPurpose":39,"observationalModel":41,"timePerspective":42,"maskingInfo":39},"COHORT","PROSPECTIVE","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.\n\nThe 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.\n\nThis 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.\n\nThe 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.","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.",[46,51,55,59],{"label":47,"type":39,"description":48,"interventionNames":49},"COPD","Individuals with COPD diagnosis",[50],"Diagnostic Test: 1MSTS",{"label":52,"type":39,"description":53,"interventionNames":54},"Heart Failure","Individuals with Heart Failure Diagnosis",[50],{"label":56,"type":39,"description":57,"interventionNames":58},"ILD","Individuals with ILD diagnosis",[50],{"label":60,"type":39,"description":61,"interventionNames":62},"Asthma","Individuals with Asthma diagnosis",[50],[64],{"type":65,"name":66,"description":67,"armGroupLabels":68,"otherNames":39},"DIAGNOSTIC_TEST","1MSTS","The 1-minute Sit-to-Stand Test",[60,47,52,56],[70],{"name":71,"role":72,"phone":73,"phoneExt":39,"email":74},"Jacob Sandberg, M.D, PhD","CONTACT","+46734471519","jacob.sandberg@bth.se",[76],{"facility":5,"status":39,"city":77,"state":78,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"Karlskrona","Blekinge County","37142","Sweden","SE",{"type":83,"coordinates":84},"Point",[85,86],15.58661,56.16156,{"lat":86,"lon":85},[89],{"name":71,"role":72,"phone":73,"phoneExt":39,"email":74},{"type":91,"investigatorFullName":92,"investigatorTitle":93,"investigatorAffiliation":5,"oldNameTitle":39,"oldOrganization":39},"SPONSOR_INVESTIGATOR","Jacob Sandberg","Postdoctoral Researcher",[95],{"name":96,"class":6},"Lund University","100657187","validation-of-1-minute-sit-to-stand-test-for-assessment-of-breathlessness-at-exertion-in-individuals-with-chronic-lung-disease-100657187",false,"NCT07836764","Validation of 1 Minute Sit-to Stand Test for Assessment of Breathlessness at Exertion in Individuals With Chronic Lung Disease","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","V1BE","Inclusion Criteria:\n\n* Have a physician diagnosis of COPD\u002FILD\u002FAsthma\u002FHF.\n* The participant has given written consent to participate in the study\n* Age 18 years or older\n* Able to cycle\n* Able to use the legs and stand up from sitting without risk of falling\n* Able to understand and speak Swedish to participate in the study procedures, as judged by the staff.\n\nExclusion Criteria:\n\n* Resting peripheral oxygen saturation (SpO2) \\\u003C 92%\n* hospitalisation or clinical instability during the last four weeks\n* Treatment with supplementary oxygen at rest or during exercise\n* contraindication to exercise testing in accordance with clinical practice guidelines\n* expected survival shorter than six months as judged by the Staff\n* medical conditions including acute coronary artery disease, neuromuscular disease or severe psychiatric illness.","ALL","18 Years",{"count":108,"type":109},120,"ESTIMATED","OBSERVATIONAL","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.\n\nThis 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.\n\nParticipants 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.\n\nThe results may help establish the 1MSTS as a practical and easy-to-use tool for assessing exertional breathlessness in both clinical practice and research.",[113,114,115],"COPD (Chronic Obstructive Pulmonary Disease)","Asthma (Diagnosis)","Interstitial Lung Disease (ILD)",[117,118,119,120,47,60,121,52,122,123,124,125,126,127,128,129],"Breathlessness","Dyspnea","Exertional Breathlessness","One-Minute Sit-to Stand Test","Interstitial Lung Disease","Exercise testing","CPET","Six-Minute Walk Test","6MWT","Functional Capacity","Validation Study","Sensor Technology","Wearable Sensors","NOT_YET_RECRUITING","2026-09-17",{"date":133,"type":134},"2026-09-23","ACTUAL",{"date":136,"type":109},"2026-11-01",{"date":138,"type":109},"2028-12",{"name":92,"class":6},1]