Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05279547

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

University Hospital Leuven

Leuven, Belgium, 3000

Actively Recruiting

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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

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