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Search / Trial NCT05279547

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

Launched by KU LEUVEN · Mar 10, 2022

Trial Information

Current as of July 27, 2025

Recruiting

Keywords

Icu Acquired Muscle Weakness Quadriceps Muscle Near Infrared Spectroscopy Oxygenation Emg Early Mobilization Bed Cycling Interval Exercise Continuous Exercise

ClinConnect Summary

This clinical trial is looking at how different types of bed-cycling exercises can help patients in the Intensive Care Unit (ICU) who may be experiencing weakness in their muscles due to their critical illness. Specifically, the study will compare two types of exercise: one that is done at a steady, moderate pace and another that alternates between high-intensity and lower-intensity periods. Researchers want to see which type of exercise leads to better muscle oxygenation and activation, which could help improve patient recovery and outcomes.

To participate in the trial, patients need to be adults who have been on a ventilator for more than 48 hours and are expected to stay in the ICU for at least another 48 hours. They should also be able to cycle actively for at least 10 minutes. However, there are certain health conditions that could exclude someone from participating, like severe obesity, ongoing heart issues, or recent surgeries. Patients who join the study can expect to undergo different cycling exercises while being monitored to see how their muscles respond, all in hopes of finding more effective ways to support recovery in ICU patients.

Gender

ALL

Eligibility criteria

  • 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

About Ku Leuven

KU Leuven, a prestigious research university located in Belgium, is renowned for its commitment to advancing medical science and improving patient care through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, KU Leuven integrates cutting-edge research with clinical practice, facilitating the development of new therapeutic strategies and medical technologies. The institution's robust infrastructure and expertise in various fields, including biotechnology, pharmacology, and public health, position it as a leader in conducting high-quality clinical research that adheres to rigorous ethical standards and regulatory requirements. Through its clinical trials, KU Leuven aims to contribute significantly to the global biomedical landscape and enhance health outcomes for diverse populations.

Locations

Leuven, , Belgium

Patients applied

0 patients applied

Trial Officials

Daniel Langer, Prof. Dr.

Principal Investigator

KU Leuven

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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