Comparing muscle oxygenation and activation during different types of bed-cycling exercises in ICU patients
Locomotor Muscle Oxygenation and Activation During Acute Interval Compared to Constant-load Bed-cycling Exercise: A Pilot Study
This study is testing whether two different types of bed-cycling exercises can help improve muscle oxygen and activation in patients recovering from weakness after being in the ICU.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | KU Leuven Academic / other |
| Locations | 1 site (Leuven) |
| Trial ID | NCT05279547 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adult patients who have been mechanically ventilated for over 48 hours and are expected to remain in the ICU for at least another 48 hours.
Not a fit: Patients with pre-existing functional limitations, severe obesity, or acute surgical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved rehabilitation protocols that enhance muscle function and recovery in critically ill patients.
How similar studies have performed: Previous studies have shown that early rehabilitation interventions in the ICU can improve patient outcomes, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Leuven
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.