[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100460739":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":41,"responsibleParty":60,"collaborators":62,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":24,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":24,"enrollmentInfo":74,"targetDuration":24,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":44,"whyStopped":24,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"KU Leuven","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1 (First constant-load then interval bed-cycling protocol)","ACTIVE_COMPARATOR","During Day 1, patients will be familiarized with the constant-load and interval bed-cycling exercise against no resistance. Patients will be also randomized in the two arms of the study before the determination of the appropriate exercise intensities to be subsequently use during the constant-load and interval bed-cycling protocols on Day 2 and Day 3. Exercise intensities will be determined so that the volume of training during the two protocols will be equal.\n\nDuring Day 2, patients randomized to arm 1 will perform the constant-load bed-cycling protocol. During Day 3, patients who executed the constant-load bed-cycling protocol on Day 1 (arm 1) will perform the interval bed-cycling protocol.",[13,14],"Other: Constant-load bed-cycling exercise","Other: Interval bed-cycling exercise",{"label":16,"type":10,"description":17,"interventionNames":18},"Arm 2 (First interval then constant-load bed-cycling protocol)","During Day 1, patients will be familiarized with the constant-load and interval bed-cycling exercise against no resistance. Patients will be also randomized in the two arms of the study before the determination of the appropriate exercise intensities to be subsequently use during the constant-load and interval bed-cycling protocols on Day 2 and Day 3. Exercise intensities will be determined so that the volume of training during the two protocols will be equal.\n\nDuring Day 2, patients randomized to arm 2 will perform the interval bed-cycling protocol. On Day 3 they will perform the constant-load bed-cycling protocol.",[13,14],[20,25],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Constant-load bed-cycling exercise","Patients will actively cycle for a minimum duration of 10 minutes and a maximum duration of 20 minutes without breaks.",[9,16],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Interval bed-cycling exercise","Patients will cycle for the same duration as during constant-load exercise. Interval bed-cycling session will consist of 30 seconds of high intensity exercise alternated by 30 seconds of passive cycling designed so that volume of training will be equal.",[9,16],[30],{"name":31,"affiliation":5,"role":32},"Daniel Langer, Prof. Dr.","PRINCIPAL_INVESTIGATOR",[34,38],{"name":31,"role":35,"phone":36,"phoneExt":24,"email":37},"CONTACT","003216376497","daniel.langer@kuleuven.be",{"name":39,"role":35,"phone":24,"phoneExt":24,"email":40},"Diego Poddighe","diego.poddighe@kuleuven.be",[42],{"facility":43,"status":44,"city":45,"state":24,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"University Hospital Leuven","RECRUITING","Leuven","3000","Belgium","BE",{"type":50,"coordinates":51},"Point",[52,53],4.70093,50.87959,{"lat":53,"lon":52},[56,58],{"name":57,"role":35,"phone":24,"phoneExt":24,"email":37},"Daniel Langer",{"name":59,"role":32,"phone":24,"phoneExt":24,"email":24},"Daniel Langer, PT, PhD",{"type":32,"investigatorFullName":57,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Prof. Dr",[63],{"name":64,"class":6},"Universitaire Ziekenhuizen KU Leuven","100460739","locomotor-muscle-oxygenation-and-activation-during-acute-interval-compared-to-constant-load-bed-cycling-exercise-100460739",false,"NCT05279547","Locomotor Muscle Oxygenation and Activation During Acute Interval Compared to Constant-load Bed-cycling Exercise","Locomotor Muscle Oxygenation and Activation During Acute Interval Compared to Constant-load Bed-cycling Exercise: A Pilot Study","Inclusion Criteria:\n\n* Full cooperatively adult patients indicated by the Adequacy Score of standardized 5 questions (SQ5) = 5\u002F5\n* Patients mechanically ventilated for longer than 48 hours during the same ICU admission\n* Patients are expected to remain in the ICU for more than an additional 48 hours starting from study enrollment\n* Patients able to perform active cycling for \\> 10 consecutive minutes\n\nExclusion Criteria:\n\n* Pre-existing functional limitations\n* Low limb injuries or conditions that would preclude in-bed cycling such as a body habitus unable to fit the bike\n* Extreme obesity (body mass index \\>35 kg\u002Fm2)\n* Neurologically unstable\n* Acute surgery\n* Palliative goals of care\n* Temperature \\> 40 °C\n* An anticipated fatal outcome\n* Evidence of coronary ischaemia, for example, chest pain or electrocardiogram changes\n* Resting heart rate \\\u003C40 or \\>120 beats per minute\n* Mean arterial pressure \\\u003C60 or \\>120 mmHg\n* Peripheral capillary oxygen saturation \\\u003C 90%\n* Wounds, trauma or surgery of leg precluding cycle ergometry\n* Wounds, trauma or surgery of pelvis precluding cycle ergometry\n* Wounds, trauma or surgery of lumbar spine precluding cycle ergometry\n* Coagulation disorder (international normalised ratio \\> 1.8, or platelets \\\u003C 50,000 mcL)\n* Intracranial pressure \\>20 mm Hg\n* Femoral access other than femoral central line\n* Acute deep vein thrombosis\n* Pulmonary embolism\n* \\>20 mcg\u002Fmin of noradrenaline\n* inotropic or vasopressor support comparable to a dose of noradrenaline \\>20mcg\u002Fmin\n* Fraction of inspired oxygen \\> 55%\n* Arterial partial pressure of oxygen (PaO2) \\\u003C65 torr (\\\u003C8.66 kPa)\n* Positive end-expiratory pressure \\> 10 cmH2O\n* Respiratory rate \\> 30 breaths per minutes with adequate ventilatory support\n* Minute ventilation \\>150 mL\u002Fkg body weight","ALL","18 Years",{"count":75,"type":76},100,"ESTIMATED","INTERVENTIONAL",[79],"NA","Up to 60% of patients admitted to the Intensive Care Unit (ICU) with a prolonged stay in the ICU develop complications such as intensive care unit acquired weakness (ICUAW) characterized by limb and respiratory muscle weakness. ICUAW is associated with worse prognosis, longer ICU stay and increased morbidity and mortality.\n\nPhysical therapy (PT) interventions in the intensive care unit (ICU), can improve patients' outcomes.\n\nHowever, improvements in muscle function achieved with standard physical activity interventions aiming at early mobilization are highly variable due to lack of consistency in definition of the interventions, lack of consideration for the complexity of exercise dose and\u002For insufficient stimulation of muscles during interventions. It has been suggested that modifying early mobilization and exercise protocols towards shorter intervals consisting of higher intensity exercises might result in more optimal stimulation of muscles.\n\nIn the present study the researchers therefore aim to simultaneously assess (by non-invasive technologies) locomotor muscle oxygenation and activation along with the measurements of the load imposed on respiration and circulation during two different training modalities i.e., moderate intensity continuous bed-cycling (endurance training) vs high-intensity alternated by lower intensity periods of bed-cycling (interval training).",[82,83],"Intensive Care Unit Acquired Weakness","Critical Illness",[85,86,87,88,89,90,91,92,93],"ICU acquired muscle weakness","Quadriceps muscle","Near-infrared spectroscopy","Oxygenation","EMG","Early-mobilization","Bed-cycling","Interval exercise","Continuous exercise","2026-03-16",{"date":96,"type":97},"2026-03-18","ACTUAL",{"date":99,"type":97},"2023-02-01",{"date":101,"type":76},"2028-12",{"name":5,"class":6},1]