Actively Recruiting
Locomotor Muscle Oxygenation and Activation During Acute Interval Compared to Constant-load Bed-cycling Exercise
Led by KU Leuven · Updated on 2026-03-18
100
Participants Needed
1
Research Sites
304 weeks
Total Duration
On this page
Sponsors
K
KU Leuven
Lead Sponsor
U
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 exercises might result in more optimal stimulation of muscles. In the present study the researchers therefore aim to simultaneously assess (by non-invasive technologies) locomotor muscle oxygenation and activation along with the measurements of the load imposed on respiration and circulation during two different training modalities i.e., moderate intensity continuous bed-cycling (endurance training) vs high-intensity alternated by lower intensity periods of bed-cycling (interval training).
CONDITIONS
Official Title
Locomotor Muscle Oxygenation and Activation During Acute Interval Compared to Constant-load Bed-cycling Exercise
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults fully cooperative with an Adequacy Score of 5 out of 5
- Mechanically ventilated for more than 48 hours during the current ICU stay
- Expected to remain in the ICU for more than 48 additional hours from enrollment
- Able to actively cycle for more than 10 consecutive minutes
You will not qualify if you...
- Pre-existing functional limitations
- Lower limb injuries or conditions preventing bed-cycling, including body shape incompatible with the bike
- Extreme obesity with body mass index over 35 kg/m2
- Neurological instability
- Acute surgery
- Palliative care goals
- Body temperature over 40 °C
- Anticipated fatal outcome
- Signs of coronary ischemia (e.g., chest pain or ECG changes)
- Resting heart rate below 40 or above 120 beats per minute
- Mean arterial pressure below 60 or above 120 mmHg
- Peripheral capillary oxygen saturation below 90%
- Wounds, trauma, or surgery in legs, pelvis, or lumbar spine preventing cycle ergometry
- Coagulation disorder with INR over 1.8 or platelets below 50,000/mcL
- Intracranial pressure above 20 mm Hg
- Femoral access other than femoral central line
- Acute deep vein thrombosis
- Pulmonary embolism
- Noradrenaline dose over 20 mcg/min or similar inotropic/vasopressor support
- Fraction of inspired oxygen over 55%
- Arterial partial pressure of oxygen below 65 torr (8.66 kPa)
- Positive end-expiratory pressure over 10 cmH2O
- Respiratory rate over 30 breaths per minute with adequate ventilation
- Minute ventilation over 150 mL/kg body weight
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Hospital Leuven
Leuven, Belgium, 3000
Actively Recruiting
Research Team
D
Daniel Langer, Prof. Dr.
CONTACT
D
Diego Poddighe
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here