[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626259":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":7,"locations":7,"responsibleParty":17,"collaborators":7,"id":21,"slug":22,"hasResults":23,"nctId":24,"briefTitle":25,"officialTitle":26,"acronym":27,"eligibilityCriteria":28,"healthyVolunteers":23,"sex":29,"minAge":30,"maxAge":7,"enrollmentInfo":31,"targetDuration":7,"studyType":34,"phases":7,"briefSummary":35,"conditions":36,"keywords":41,"overallStatus":50,"whyStopped":7,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":7},{"fullName":5,"class":6},"Nemocnice AGEL Trinec-Podlesi a.s.","OTHER",null,[9,13],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"PROCEDURE","SET physiotherapy","36-session AHA 2019-concordant supervised exercise programme delivered over 12 weeks (3 sessions per week, 60 minutes each). Each session consists of 45 minutes of structured treadmill and resistance exercise plus 15 minutes of patient education on vascular risk factor management. Treadmill protocol: 3.2 km\u002Fh, walking to claudication pain level 3 on a four-point scale, resting to level 1, five to six cycles per session. Progression weeks 1-4: speed +0.3 km\u002Fh every two weeks (maximum 4.0 km\u002Fh); weeks 5-8: grade +1% every two weeks (maximum 3%). Resistance training from week 5 targeting major lower extremity muscle groups (progressing from 2 sets × 10 repetitions to 5 sets at \\~70% one-repetition maximum). This is standard clinical care; the study does not allocate participants to exercise.",{"type":14,"name":15,"description":16,"armGroupLabels":7,"otherNames":7},"RADIATION","CT scan","Single-slice CT body composition analysis at the L3 vertebral level, extracted opportunistically from existing diagnostic CT angiography. Segmentation performed using AutoMATiCA (U-Net convolutional neural network). Compartments quantified: skeletal muscle (-29 to +150 HU within muscle fascia mask), visceral adipose tissue (-150 to -50 HU within peritoneal cavity), subcutaneous adipose tissue (-190 to -30 HU exterior to body wall), and intramuscular adipose tissue (-190 to -30 HU within muscle fascia, exterior to individual muscle boundaries). A second dedicated CT acquisition is performed at 3 months (T1) for exploratory longitudinal analysis.",{"type":18,"investigatorFullName":19,"investigatorTitle":20,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"PRINCIPAL_INVESTIGATOR","Matej Pekar, MD, PhD","Principal Investigator","100626259","ct-body-composition-as-predictor-of-exercise-therapy-outcome-in-peripheral-arterial-disease-100626259",false,"NCT07433309","CT Body Composition as Predictor of Exercise Therapy Outcome in Peripheral Arterial Disease","CT Body Composition Predicts Supervised Exercise Response in Peripheral Arterial Disease: A Protocol","COMPOSE-PAD","Inclusion Criteria:\n\n* Age 18 years or older\n* Confirmed peripheral arterial disease (PAD) defined by at least one of: resting ankle-brachial index (ABI) ≤0.90, duplex ultrasonography demonstrating ≥50% stenosis in a relevant lower extremity vessel, or CT angiography (CTA) or magnetic resonance angiography (MRA) demonstrating flow-limiting lower extremity arterial disease\n* Fontaine stage IIa or IIb intermittent claudication\n* Scheduled for the institutional 36-session supervised exercise therapy (SET) programme\n* Existing CTA with an axial slice at the L3 vertebral level suitable for automated body composition analysis\n* Capacity to provide written informed consent\n\nExclusion Criteria:\n\n* Fontaine stage III or IV peripheral arterial disease (rest pain or tissue loss; critical limb-threatening ischaemia)\n* Ipsilateral lower extremity revascularisation within 6 months prior to enrolment\n* Absolute contraindication to structured exercise (e.g., unstable coronary artery disease, severe pulmonary hypertension, uncontrolled arrhythmia, or other condition precluding participation in a supervised treadmill and resistance exercise programme)\n* Cognitive impairment (Mini-Mental State Examination \\[MMSE\\] score \\\u003C24)\n* Active malignancy or systemic condition expected to substantially alter body composition independently of the exercise intervention during the study period\n* Estimated life expectancy less than 12 months","ALL","18 Years",{"count":32,"type":33},128,"ESTIMATED","OBSERVATIONAL","Supervised exercise therapy (SET) is the recommended first treatment for patients with leg artery disease (peripheral arterial disease, PAD) causing pain when walking. However, approximately 40% of patients do not benefit meaningfully and go on to require a procedure to open the blocked arteries within three months. This study investigates whether body composition measurements - specifically the quality of muscle and the amount of belly fat - taken from a CT scan already performed as part of routine care, can identify before treatment begins which patients are unlikely to respond to exercise therapy. If confirmed, this approach would allow doctors to use information from a scan patients are already having, with no additional tests, to better match patients to the right treatment from the start.",[37,38,39,40],"Sarcopenia","Body Composition","Sarcopenic Obesity","Peripheral Arterial Disease",[42,43,44,45,46,47,48,49],"Peripheral arterial disease","intermittent claudication","supervised exercise therapy","computed tomography body composition","myosteatosis","visceral adipose tissue","sarcopenic obesity","treatment outcome prediction","NOT_YET_RECRUITING","2026-02-20",{"date":53,"type":54},"2026-02-25","ACTUAL",{"date":56,"type":33},"2026-06-01",{"date":58,"type":33},"2031-01-31",{"name":5,"class":6}]