[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100446565":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":42,"studyPopulation":43,"armGroups":44,"interventions":39,"overallOfficials":51,"centralContacts":56,"locations":65,"responsibleParty":79,"collaborators":81,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":92,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":39,"studyType":99,"phases":39,"briefSummary":100,"conditions":101,"keywords":106,"overallStatus":68,"whyStopped":39,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"University of Leicester","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":31},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"30 days hospital re-admission rate","To calculate the percentage of readmission due to the same acute respiratory illness within 30 days from consent","30 days",{"measure":14,"description":15,"timeFrame":16},"Length of index hospital admission stay","To calculate the length of the index hospital stay","Variable (up to 52 weeks)",{"measure":18,"description":19,"timeFrame":12},"30 days mortality rate","To calculate the percentage of mortality within 30 days from consent",[21,25,28],{"measure":22,"description":23,"timeFrame":24},"Total number of hospital readmission due to same underlying chronic lung disease.","To evaluate the number of hospital readmission episodes due to same underlying chronic lung disease over a 52 weeks period.","52 weeks",{"measure":26,"description":27,"timeFrame":24},"Total number of non-hospitalised exacerbations of underlying chronic lung disease","To evaluate the number of non-hospitalised exacerbations of chronic lung disease e.g. asthma, Chronic Obstructive Pulmonary Diseases (COPD), etc. over 52 weeks",{"measure":29,"description":30,"timeFrame":24},"Time from consent to death (respiratory causes and all causes)","To measure the time from consent to death within 52 weeks from consent. This will include both respiratory and all causes of mortality",[32,35],{"measure":33,"description":34,"timeFrame":24},"Assessment of breathlessness using eMRC dyspnoea scale","To evaluate the degree of breathlessness at baseline and following recovery from acute respiratory illness using Extended MRC dyspnoea scale(eMRC). eMRC dyspnoea scale ranges from 1 to 5b with higher score indicates worse outcomes.",{"measure":36,"description":37,"timeFrame":24},"Assessment of quality of Life\u002Fsymptoms using St. George's Respiratory Questionnaire (SGRQ)","St. George's Respiratory Questionnaire (SGRQ) is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with higher scores indicating more limitations.",{"allocation":39,"interventionModel":39,"interventionModelDescription":39,"primaryPurpose":39,"observationalModel":40,"timePerspective":41,"maskingInfo":39},null,"COHORT","PROSPECTIVE","The study will recruit adults who are either admitted to hospital with an acute respiratory condition or are under the care of hospital respiratory outpatient services for a chronic respiratory disease. Acute respiratory presentations may include exacerbations of chronic lung diseases such as chronic obstructive pulmonary disease (COPD), asthma, interstitial lung disease, bronchiectasis and pleural disease, as well as acute respiratory illnesses including pneumonia, respiratory infection and pulmonary embolism. A separate healthy control group without underlying respiratory disease will also be recruited for comparison of selected exploratory measures.\n\nParticipants may be recruited during hospital admission or through respiratory outpatient services. Baseline assessments will be completed during hospitalisation or within 90 days of a routine clinical follow-up appointment, depending on the route of recruitment.\n\nParticipants recruited during an acute hospital admission may be invited to complete an early post-discharge assessment at approximately 30 days and up to three additional optional follow-up visits during the 12 months after discharge to assess clinical recovery. Participants recruited through respiratory outpatient services will be invited to undergo annual follow-up assessments. Follow-up for the main cohort will continue for up to 36 months, with permitted visit windows of up to 90 days.\n\nFollow-up assessments may be completed by telephone, during a face-to-face research visit at the Biomedical Research Centre, during a research visit for another ethically approved study, or alongside routine clinical follow-up. Participants may choose not to attend further study visits after recruitment without affecting their usual clinical care.\n\nIf a participant is admitted to hospital during study follow-up, they may be invited to complete an additional assessment during the acute admission, within 7 days of hospitalisation, followed by up to three further assessments during the subsequent 12 months. Healthcare utilisation and clinical outcome data, including subsequent hospital admissions and treatments, may also be collected remotely from primary and secondary healthcare records.\n\nStudy assessments may include clinical characteristics, symptoms, health-related quality of life, frailty, sarcopenia, physical function, muscle strength, lung function, physical activity, body composition, muscle structure and function, physiological measurements, imaging and biological samples. These data will be used to characterise recovery following acute respiratory illness, investigate hospital-associated disability, explore potential biomarkers and develop approaches to risk stratification.\n\nHealthy controls will undergo a baseline assessment only and will provide comparator data for selected exploratory outcomes.\n\nMPES SUB-STUDY:\n\nThe Muscle Phenotyping Exploratory Study (MPES) is a sub-study nested within CHESTY and will be conducted at Glenfield Hospital. It is designed to provide more detailed assessment of skeletal muscle structure, function and metabolism using methods that complement the broader clinical phenotyping undertaken in the main CHESTY cohort.\n\nThe sub-study has two main aims. First, it will assess the feasibility, safety and tolerability of the additional muscle phenotyping methods, including high-density surface electromyography (EMG), ingested stable isotope tracer methodology and muscle biopsy procedures, in participants with respiratory disease and healthy volunteers. Second, it will use these methods exploratorily to undertake detailed skeletal muscle phenotyping, including assessment of muscle activation and neuromuscular function, skeletal muscle mass, muscle protein synthesis and muscle protein breakdown.\n\nUp to 20 participants will be recruited to each of three groups: patients hospitalised with an acute exacerbation of COPD, patients with stable COPD, and age-comparable control participants without chronic respiratory disease. Participants may be recruited from existing CHESTY participants who have provided appropriate consent or through the same screening and recruitment pathways used for the main CHESTY study.\n\nThe MPES sub-study will use the same study site, research team and core assessments as CHESTY, including measures of physical function and muscle strength, questionnaires and muscle biopsy procedures where applicable.","Participants will include adults admitted to hospital with an acute respiratory condition, including exacerbations of an underlying physician-diagnosed chronic respiratory disease, as well as non-hospitalised patients under respiratory outpatient follow-up for a chronic respiratory condition. The study will also include healthy volunteers without chronic respiratory disease as a comparator group. Co-participation in other ethically approved studies, including interventional trials, is permitted.",[45,48],{"label":46,"type":39,"description":47,"interventionNames":39},"Hospitalised Patients","Participants admitted to hospital with an acute respiratory condition including exacerbation of an underlying physician diagnosed chronic lung disease.",{"label":49,"type":39,"description":50,"interventionNames":39},"Matched Controls (stable COPD and healthy volunteers)","The study will include matched controls (non-hospitalised patients with stable chronic respiratory conditions or healthy volunteers) to compare the exploratory endpoints. The number of the matched controls will not exceed 25% of the main study recruitment.",[52],{"name":53,"affiliation":54,"role":55},"Neil Greening, PhD, MRCP","NIHR Respiratory Biomedical Research Centre, Leicester","PRINCIPAL_INVESTIGATOR",[57,62],{"name":58,"role":59,"phone":60,"phoneExt":39,"email":61},"Jill Clanchy","CONTACT","+44 (0)116 258 3370","chesty-catalina@leicester.ac.uk",{"name":63,"role":59,"phone":39,"phoneExt":39,"email":64},"Hamish McAuley, MBBS, MRCP","hjcm1@leicester.ac.uk",[66],{"facility":67,"status":68,"city":69,"state":39,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":39},"Glenfield Hospital","RECRUITING","Leicester","LE3 9QP","United Kingdom","UK",{"type":74,"coordinates":75},"Point",[76,77],-1.13169,52.6386,{"lat":77,"lon":76},{"type":80,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR",[82],{"name":83,"class":6},"University Hospitals, Leicester","100446565","study-of-hospitalised-patients-with-acute-respiratory-conditions-100446565",false,"NCT05095090","Study of Hospitalised Patients With Acute Respiratory Conditions","Observational Cohort Study of Hospitalised Patients With Acute Respiratory Conditions","CHESTY","Inclusion Criteria (Core study participants)\n\n1. Hospital admission with an acute respiratory diagnosis, or currently under the care of hospital respiratory outpatient services for a chronic respiratory disease\n2. Participant is willing \\& able to give informed consent for participation in the study\n3. Aged 18 years or above\n4. Able (in the Investigators opinion) \\& willing to comply with all study requirements\n\nExclusion Criteria (Core study participants)\n\n1. Unstable or life-threatening cardiac disease including myocardial infarction or unstable angina during current admission.\n2. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.\n3. Known pregnancy\n\nInclusion Criteria (Healthy Controls)\n\n1. Aged 18 years or above\n2. No underlying respiratory disease as self-reported\n3. Able (in the Investigators opinion) \\& willing to comply with all study requirements\n\nExclusion Criteria (Healthy Controls)\n\n1. Hospitalised due to an acute respiratory illness in the last 6 weeks prior to consent\n2. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.\n3. Known pregnancy\n\nAdditional inclusion and exclusion criteria for CHESTY sub-studies are detailed in the corresponding sub-study protocols.",true,"ALL","18 Years","90 Years",{"count":97,"type":98},500,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to learn about the short- and long-term outcomes of people admitted to hospital with an acute respiratory condition, including exacerbations of chronic lung disease, and to understand factors that may predict recovery, hospital readmission, length of hospital stay, and mortality. A group of people with chronic respiratory disease who are being followed in respiratory outpatient clinics and a healthy control group without lung disease will also take part.\n\nThe main questions it aims to answer are:\n\n* Which clinical, physical, functional, and biological characteristics are associated with short-term outcomes after hospitalisation, including 30-day hospital readmission, length of hospital stay, and 30-day mortality?\n* Which characteristics are associated with longer-term recovery, future exacerbations, hospital readmissions, healthcare use, and mortality?\n* Can measurements taken during or around the time of hospitalisation be used to identify people at greater risk of poor outcomes who may benefit from targeted interventions?\n\nParticipants will undergo clinical assessments that may include questionnaires, measurements of physical function and muscle strength, lung function tests, physical activity monitoring, and collection of biological samples. Some participants may also undergo additional assessments of body composition, muscle size and function, imaging, or muscle metabolism, including through nested sub-studies. Participants will be followed for up to 36 months to assess recovery and longer-term clinical outcomes.",[102,103,104,105],"Acute Respiratory Disease","COPD Exacerbation Acute","Asthma","Pneumonia",[104,107,105,108,109,110,111],"COPD (Chronic Obstructive Pulmonary Disease)","ILD (Interstitial Lung Diseases)","Pulmonary Embolism","Pleural Diseases","Bronchiectasis","2026-10-01",{"date":114,"type":115},"2026-10-06","ACTUAL",{"date":117,"type":115},"2022-02-02",{"date":119,"type":98},"2033-10-30",{"name":5,"class":6},1]