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Locomotor Muscle Oxygenation and Activation During Acute Interval Compared to Constant-load Bed-cycling Exercise

RecruitingNAAges 18 Years - anyAllKU Leuven
NCT05279547 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. Physical therapy (PT) interventions in the intensive care unit (ICU), can improve patients' outcomes. However, 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/or insufficient stimulation of muscles during interventions. It has been suggested that modifying early mobilization and exercise protocols towards shorter intervals consisting of higher intensity exer

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📋 Eligibility rules (as published)
Inclusion Criteria: * Full cooperatively adult patients indicated by the Adequacy Score of standardized 5 questions (SQ5) = 5/5 * Patients mechanically ventilated for longer than 48 hours during the same ICU admission * Patients are expected to remain in the ICU for more than an additional 48 hours starting from study enrollment * Patients able to perform active cycling for \> 10 consecutive minutes Exclusion Criteria: * Pre-existing functional limitations * Low limb injuries or conditions that would preclude in-bed cycling such as a body habitus unable to fit the bike * Extreme obesity (body mass index \>35 kg/m2) * Neurologically unstable * Acute surgery * Palliative goals of care * Temperature \> 40 °C * An anticipated fatal outcome * Evidence of coronary ischaemia, for example, chest pain or electrocardiogram changes * Resting heart rate \<40 or \>120 beats per minute * Mean arterial pressure \<60 or \>120 mmHg * Peripheral capillary oxygen saturation \< 90% * Wounds, trauma or surgery of leg precluding cycle ergometry * Wounds, trauma or surgery of pelvis precluding cycle ergometry * Wounds, trauma or surgery of lumbar spine precluding cycle ergometry * Coagulation disorder (international normalised ratio \> 1.8, or platelets \< 50,000 mcL) * Intracranial pressure \>20 mm Hg * Femoral access other than femoral central line * Acute deep vein thrombosis * Pulmonary embolism * \>20 mcg/min of noradrenaline * inotropic or vasopressor support comparable to a dose of noradrenaline \>20mcg/min * Fraction of inspired oxygen \> 55% * Arterial partial pressure of oxygen (PaO2) \<65 torr (\<8.66 kPa) * Positive end-expiratory pressure \> 10 cmH2O * Respiratory rate \> 30 breaths per minutes with adequate ventilatory support * Minute ventilation \>150 mL/kg body weight
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What it tests

  • Constant-load bed-cycling exercise
  • Interval bed-cycling exercise
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Where

1 site
University Hospital Leuven
Leuven, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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