Early rehabilitation reduces the likelihood of developing intensive care unit-acquired weakness: a systematic review and meta-analysis.
David E Anekwe, Sharmistha Biswas, André Bussières...
https://pubmed.ncbi.nlm.nih.gov/32135387Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05279547
Locomotor Muscle Oxygenation and Activation During Acute Interval Compared to Constant-load Bed-cycling Exercise: A Pilot Study
Led by KU Leuven · Updated on 2026-03-18
100
Participants Needed
1
Research Sites
N/A
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
This research investigates patients who have been in the Intensive Care Unit (ICU) for a prolonged time and may develop ICU-acquired weakness, which causes muscle weakness in limbs and respiratory muscles. This condition is linked to worse outcomes, longer ICU stays, and higher risks of complications and death. The study aims to compare two types of bed-cycling exercises to see how they affect muscle oxygenation and activation, as well as the load on breathing and circulation in critically ill patients. Participants will take part in two types of bed-cycling exercises: one is a moderate-intensity continuous cycling (endurance training), and the other is a high-intensity interval cycling alternating with lower intensity periods. On Day 1, patients will get familiar with both exercises without resistance and will be randomly assigned to start with either the constant-load or interval protocol. On Days 2 and 3, they will perform the assigned exercises with intensities adjusted to ensure equal training volume across protocols. During the study, researchers will monitor muscle oxygen saturation and activation in the quadriceps muscle, along with heart rate, blood pressure, breathing rate, and oxygen levels. They will also track adverse events and how well patients complete the exercise sessions. The study spans two different exercise days within one week, assessing differences between the two exercise methods. The total participation timeline includes familiarization and two exercise sessions, with close monitoring of safety and physiological responses.
CONDITIONS
Brief 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
You may qualify if you...
- Adults aged 18 years or older
- Fully cooperative patients indicated by a standardized 5-question adequacy score of 5/5
- Patients mechanically ventilated for more than 48 hours during the same ICU admission
- Patients expected to stay in the ICU for at least 48 more hours from study enrollment
- Patients able to perform active cycling for more than 10 consecutive minutes
You will not qualify if you...
- Pre-existing functional limitations
- Injuries or conditions in lower limbs that prevent in-bed cycling, including inability to fit the bike
- Extreme obesity with body mass index over 35 kg/m2
- Neurologically unstable patients
- Acute surgery
- Patients with palliative goals of care
- Body temperature above 40 degrees Celsius
- Anticipated fatal outcome
- Signs of coronary ischemia such as 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 oxygen saturation below 90%
- Wounds, trauma, or surgery in leg, pelvis, or lumbar spine preventing cycle ergometry
- Coagulation disorders with INR above 1.8 or platelets under 50,000 per microliter
- Intracranial pressure above 20 mm Hg
- Femoral access other than a central line
- Acute deep vein thrombosis or pulmonary embolism
- Use of noradrenaline over 20 mcg/min or similar vasopressor support
- Fraction of inspired oxygen above 55%
- Arterial partial pressure of oxygen below 65 torr (8.66 kPa)
- Positive end-expiratory pressure above 10 cmH2O
- Respiratory rate over 30 breaths per minute despite support
- Minute ventilation exceeding 150 mL/kg body weight
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Familiarization and Exercise Intensity Determination
Duration - 1 day
Participants are familiarized with the constant-load and interval bed-cycling exercises and randomized to one of two exercise sequences. Exercise intensities are determined to ensure equal training volume for both protocols.
1 visit (in-person)
Exercise Treatment
Duration - 2 days within 1 week
Participants perform two exercise sessions on separate days within one week, completing both constant-load and interval bed-cycling protocols in randomized order.
2 visits (in-person)
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.
D
Diego Poddighe
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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Early mobilisation in mechanically ventilated patients: a systematic integrative review of definitions and activities.
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Gerald S Supinski, Emily N Valentine, Paul F Netzel...
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Julius J Grunow, Moritz Goll, Niklas M Carbon...
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Julie C Reid, France Clarke, Deborah J Cook...
https://pubmed.ncbi.nlm.nih.gov/30669936Early mobilization in clinical practice: the reliability and feasibility of the 'Start To Move' Protocol.
Mariana Hoffman, Beatrix Clerckx, Kristel Janssen...
https://pubmed.ncbi.nlm.nih.gov/32866055Acceptability, safety, and feasibility of in-bed cycling with critically ill patients.
Marc R Nickels, Leanne M Aitken, Adrian G Barnett...
https://pubmed.ncbi.nlm.nih.gov/32317212