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Compares treatment options for Intensive Care Unit Acquired Weakness
Official title Locomotor Muscle Oxygenation and Activation During Acute Interval Compared to Constant-load Bed-cycling Exercise
ClinicalTrials.gov ID: NCT05279547
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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 \ 120 beats per minute
- Mean arterial pressure \ 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
The study team makes the final eligibility decision.
Where it's taking place
- Leuven, Belgium
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leuven, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.