Comparing muscle oxygenation and activation during different types of bed-cycling exercises in ICU patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of two types of bed-cycling exercises—constant-load and interval—on muscle oxygenation and activation in patients with Intensive Care Unit Acquired Weakness (ICUAW). The research aims to determine if interval exercises can provide better muscle stimulation compared to constant-load exercises, potentially improving outcomes for critically ill patients. By utilizing near-infrared spectroscopy and electromyography, the study will measure muscle responses during these interventions. The goal is to enhance rehabilitation strategies for ICU patients to mitigate the effects of prolonged immobility and critical illness.

Why it matters

Who can join: the full rules

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

Where it's running

• University Hospital Leuven
  Leuven, Belgium Recruiting

Study contacts

• Principal investigator: Daniel Langer, Prof. Dr. — KU Leuven
• Study coordinator: Daniel Langer, Prof. Dr.
• Email: daniel.langer@kuleuven.be
• Phone: 003216376497

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.