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Critical IllnessAcuteBike-ICUNCT07882719

Quadriceps Muscle Activation and Oxygenation Responses During Usual Care Compared to Individualized Interval and Constant Work Rate Bed-cycling. An Experimental Study.

A study testing Individualized constant work rate bedcycling and Individualized interval bedcycling in people with Critical Illness, run by KU Leuven.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

### Study Summary - AcuteBike-ICU Bed-cycling is commonly used as part of early rehabilitation in critically ill patients in the intensive care unit (ICU). However, the extent to which usual care bed-cycling activates the quadriceps muscles remains unclear, as does whether individualized exercise protocols can… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Critical Illness
What is being tested?
Individualized constant work rate bedcycling and Individualized interval bedcycling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
No sites listed yet
Study dates
Nov 2026to May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntary written informed consent of the participant has been obtained prior to the initiation of any study-related measurements
  • Adults (≥18 years)
  • Mechanically ventilated for ≥ 48 hours consecutively
  • Fully cooperative, as assessed daily during routine clinical care by ICU physiotherapists using five standardized commands ("open/close your eyes", "look at me", "open your mouth and stick out your tongue", "nod your head", and "raise your eyebrows when I have counted to 5").
  • Able to perform active cycling for >10 consecutive minutes
  • Expected to remain in the ICU for more than an additional 4 days starting from study enrolment.
Show all 19Show fewer
  • Exclusion criteria MEDICAL STABILITY A. Hemodynamic instability
  • Evidence of acute coronary ischemia
  • Heart rate <40 or >120 beats per minute
  • Mean arterial pressure <60 or >110 mmHg
  • Noradrenaline or comparable inotropic or vasopressor support (norepinephrine >0.2ug/kg/min, dobutamine >5ug/kg/min, corotrope >0.2 ug/kg/min) B. Respiratory instability
  • Fraction of inspired oxygen ≥ 60%
  • PaO₂/FiO₂ ratio < 200
  • Positive end-expiratory pressure > 10 cmH2O
  • Respiratory rate > 30 breaths·min-¹ C. Surgery within the past 24h D. Body temperature > 40 oC CONDITIONS IMPAIRING CYCLING MOVEMENT
  • Trauma or surgery to lower limb, pelvis lumbar spine
  • Extreme obesity (body mass index >35 kg/m2)
  • Extensive abdominal wounds or pressure ulcers
  • Continuous renal replacement therapy by CVVH-femoral catheter PALIATIVE CARE

Who cannot join

None listed.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

About this study

### Study Summary - AcuteBike-ICU

Bed-cycling is commonly used as part of early rehabilitation in critically ill patients in the intensive care unit (ICU). However, the extent to which usual care bed-cycling activates the quadriceps muscles remains unclear, as does whether individualized exercise protocols can increase muscle stimulation.

Read more

The AcuteBike-ICU study is an experimental study aiming to compare the acute physiological responses to three bed-cycling protocols in critically ill patients: usual care constant work-rate cycling (u-CWR), individualized constant work-rate cycling (i-CWR), and individualized interval training (i-IT).

A total of 29 critically ill patients admitted to medical or surgical ICUs will be included. Participants will undergo an incremental loading test to determine their individual exercise capacity, followed by the different cycling protocols. The individualized continuous protocol involves cycling against a moderate resistance, whereas interval training alternates short periods of high-intensity cycling with passive cycling.

The primary outcome is quadriceps muscle activation, assessed using surface electromyography (sEMG) across four quadriceps muscle regions. Secondary outcomes include muscle fatigue, activation heterogeneity, muscle oxygenation and metabolism assessed using near-infrared spectroscopy (NIRS), as well as safety, feasibility, and patient-reported symptoms. Retrospective data from routine bed-cycling sessions will also be analyzed to characterize current clinical practice.

Each participant will complete the study within a maximum of five days.

By identifying which cycling protocol elicits the greatest quadriceps muscle stimulation, this study aims to support the development of more individualized and potentially more effective early rehabilitation strategies for critically ill patients.

Being tested
usual care constant work rate bedcycling, Individualized constant work rate bedcycling, Individualized interval bedcycling
Keywords
critical illness, early mobilisation, rehabilitation, cycling
Medical subject headings
Critical Illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • usual care constant work rate bedcyclingOther

    Participants will perform a usual care cycling session using the bed cycle according to routine clinical practice. The training intensity will be determined by the treating physiotherapist, without knowledge of the maximal exercise capacity. The cycling session will last for a maximum of 20 minutes.

  • Individualized constant work rate bedcyclingOther

    patients will perform continuous active cycling at 50% of maximal exercise capacity. Patients will remain in the same body position as during the other cycling protocols and the cycling duration of the 2 individualized cycling protocols (i-CWR and i-IT) will be matched with a maximal duration of 20 minutes.

  • Individualized interval bedcyclingOther

    Patients will perform interval cycling with alternating 30-second periods of active cycling at 100% of the maximal tolerated intensity level and 30-second periods of motor-assisted passive cycling without resistance. Patients will remain in the same body position as during the other cycling protocols and the cycling duration of the 2 individualized cycling protocols (i-CWR and i-IT) will be matched with a maximal duration of 20 minutes.

Study groups in NCT07882719
Study groupRoleWhat they receive
i-CWR / i-ITExperimentalIndividualized continuous work-rate cycling (i-CWR) will be provided on day 2, followed by the individualized interval training (i-IT) on day 3. Both individualized cycling modalities will be prescribed based on the results of the incremental loading test performed on day 1
Receives: Other: usual care constant work rate bedcycling; Other: Individualized constant work rate bedcycling; Other: Individualized interval bedcycling
i-IT / i-CWRExperimentalIndividualized interval training (i-IT) will be provided on day 2, followed by the individualized continuous work-rate cycling (i-CWR) on day 3. Both individualized cycling modalities will be prescribed based on the results of the incremental loading test performed on day 1
Receives: Other: usual care constant work rate bedcycling; Other: Individualized constant work rate bedcycling; Other: Individualized interval bedcycling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Average Quadriceps Muscle Activation During Bed-Cycling

    Average quadriceps muscle activation will be assessed using surface electromyography (sEMG) during the cycling protocols (u-CWR, i-CWR and i-IT). Activation will be expressed as normalized root mean square (RMS) amplitude relative to maximal voluntary contraction (%max), averaged across four quadriceps regions: vastus lateralis, vastus medialis, upper rectus femoris, and lower rectus femoris.

    Measured: During each bed-cycling session (Days 1-3; within a maximum of 5 days).

Secondary outcomes (25)
  1. Quadriceps muscle fatigue (Median Frequency)

    Muscle fatigue will be assessed by changes in the median frequency (Hz) of the surface electromyography signal over the four quadriceps regions during the incremental loading test and the three cycling protocols. A reduction in median frequency is considered indicative of muscle fatigue.

    Measured: During the incremental loading test and each cycling session (Days 0-3; within 5 days).

  2. Quadriceps muscle fatigue (Frequency ratio)

    Muscle fatigue will be assessed using changes in the high-frequency to low-frequency ratio of the sEMG signal across the four quadriceps regions during exercise.

    Measured: During the incremental loading test and each cycling session (Days 0-3; within 5 days).

  3. Spatial heterogeneity of quadriceps muscle activation

    Spatial heterogeneity of quadriceps muscle activation will be quantified as the relative dispersion of normalized sEMG amplitude across four quadriceps regions. Relative dispersion will be calculated as the standard deviation divided by the mean activation across the four regions.

    Measured: During the incremental loading test and each cycling session (Days 0-3; within 5 days).

  4. Quadriceps muscle oxygenation

    Local quadriceps muscle tissue oxygen saturation (StiO2, %) will be continuously assessed using near-infrared spectroscopy (NIRS) at four muscle regions: vastus lateralis, vastus medialis, upper rectus femoris, and lower rectus femoris. Resting values and oxygenation responses during exercise will be assessed across the cycling protocols.

    Measured: At rest, during and immediately after the incremental loading test and each cycling session (Days 0-3; within 5 days).

  5. Quadriceps muscle hemoglobine and Myoglobine Responses (oxygenated)

    Near-infrared spectroscopy (NIRS) will be used to assess oxygenated hemoglobin/myoglobin signals in four quadriceps regions during exercise.

    Measured: At rest, during and immediately after the incremental loading test and each cycling session (Days 0-3; within 5 days).

  6. Quadriceps muscle hemoglobine and Myoglobine Responses (deoxygenated)

    Near-infrared spectroscopy (NIRS) will be used to assess deoxygenated hemoglobin/myoglobin signals in four quadriceps regions during exercise.

    Measured: At rest, during and immediately after the incremental loading test and each cycling session (Days 0-3; within 5 days)

  7. Quadriceps muscle hemoglobine and Myoglobine Responses (total)

    Near-infrared spectroscopy (NIRS) will be used to assess total hemoglobin/myoglobin signals in four quadriceps regions during exercise.

    Measured: At rest, during and immediately after the incremental loading test and each cycling session (Days 0-3; within 5 days).

  8. Spatial Heterogeneity of Quadriceps Muscle Oxygenation

    Spatial heterogeneity of muscle oxygenation will be quantified using the relative dispersion of NIRS-derived muscle tissue oxygen saturation (StiO2) across four quadriceps regions.

    Measured: At rest and during the incremental loading test and each cycling session (Days 0-3; within 5 days).

  9. Changes in haert rate during Bed-Cycling

    Hemodynamic responses will be assessed using changes in heart rate (beats/min), measured before, during and after exercise.

    Measured: Before, during and immediately after the incremental loading test and each cycling session (Days 0-3; within 5 days).

  10. Changes in mean arterial blood pressure during Bed-Cycling

    Hemodynamic responses will be assessed using changes in mean arterial blood pressure (mmHg), measured before, during and after exercise.

    Measured: Before, during and immediately after the incremental loading test and each cycling session (Days 0-3; within 5 days).

  11. Changes in respiratory rate During Bed-Cycling

    Respiratory responses will be assessed using changes in respiratory rate (breaths/min) before, during and after exercise.

    Measured: Before, during and immediately after the incremental loading test and each cycling session (Days 0-3; within 5 days).

  12. Changes in peripheral oxygen saturation During Bed-Cycling

    Respiratory responses will be assessed using changes in peripheral oxygen saturation (SpO2, %) before, during and after exercise.

    Measured: Before, during and immediately after the incremental loading test and each cycling session (Days 0-3; within 5 days).

  13. Changes in fraction of inspired oxygen During Bed-Cycling

    Respiratory responses will be assessed using changes in fraction of inspired oxygen (FiO2, %) before, during and after exercise.

    Measured: Before, during and immediately after the incremental loading test and each cycling session (Days 0-3; within 5 days).

  14. Changes in Arterial Blood Gas (arterial oxygen partial pressure) During Bed-Cycling

    arterial oxygen partial pressure (PaO2) obtained as part of routine clinical care will be assessed before and after exercise.

    Measured: Before and after the incremental loading test and each cycling session (Days 0-3; within 5 days).

  15. Changes in Arterial Blood Gas (arterial carbon dioxide partial pressure) During Bed-Cycling

    Arterial carbon dioxide partial pressure (PaCO2) obtained as part of routine clinical care will be assessed before and after exercise.

    Measured: Before and after the incremental loading test and each cycling session (Days 0-3; within 5 days).

  16. Changes in Arterial Blood Gas (arterial oxygen saturation) During Bed-Cycling

    arterial oxygen saturation (SaO2) obtained as part of routine clinical care will be assessed before and after exercise.

    Measured: Before and after the incremental loading test and each cycling session (Days 0-3; within 5 days).

  17. Changes in Arterial Blood Gas (pH) During Bed-Cycling

    pH obtained as part of routine clinical care will be assessed before and after exercise.

    Measured: Before and after the incremental loading test and each cycling session (Days 0-3; within 5 days).

  18. Changes in Arterial Blood Gas (hemoglobin concentration) During Bed-Cycling

    hemoglobin concentration obtained as part of routine clinical care will be assessed before and after exercise.

    Measured: Before and after the incremental loading test and each cycling session (Days 0-3; within 5 days).

  19. Changes in Arterial Blood Gas (blood lactate concentration) During Bed-Cycling

    blood lactate concentration obtained as part of routine clinical care will be assessed before and after exercise.

    Measured: Before and after the incremental loading test and each cycling session (Days 0-3; within 5 days).

  20. Exercise-Related Safety Events and In-Session Stopping Criteria

    The number and proportion of exercise sessions associated with predefined stopping criteria or exercise-related safety events will be recorded during cycling and within 10 minutes after exercise.

    Measured: During exercise and up to 10 minutes after each session (Days 0-3; within 5 days).

  21. Proportion of Planned Bed-Cycling Sessions Initiated

    Feasibility will be assessed as the percentage of planned individualized constant work-rate cycling (i-CWR) and individualized interval training (i-IT) sessions that can be initiated. The number of initiated sessions will be divided by the number of planned sessions and multiplied by 100.

    Measured: Across the individualized cycling sessions (Days 0-3; within 5 days).

  22. Proportion of Initiated Bed-Cycling Sessions Completed

    Feasibility will be assessed as the percentage of initiated individualized cycling sessions completed according to protocol. The number of completed sessions will be divided by the number of initiated sessions and multiplied by 100. Reasons for premature termination and protocol deviations will be recorded.

    Measured: Across the individualized cycling sessions (Days 0-3; within 5 days).

  23. Self-Reported Dyspnea During Bed-Cycling

    Dyspnea will be assessed using a modified Borg scale ranging from 0 (no dyspnea) to 10 (maximal dyspnea), at baseline, after each completed minute of exercise, and at the end of each session.

    Measured: Before, during and immediately after the incremental loading test and each cycling session (Days 0-3; within 5 days).

  24. Self-Reported Leg Fatigue During Bed-Cycling

    Perceived leg fatigue will be assessed using a modified Borg scale ranging from 0 (no leg fatigue) to 10 (maximal leg fatigue), at baseline, after each completed minute of exercise, and at the end of each session.

    Measured: Before, during and immediately after the incremental loading test and each cycling session (Days 0-3; within 5 days).

  25. Self-Reported Exercise Unpleasantness

    Exercise-related unpleasantness will be assessed using a modified Borg scale ranging from 0 to 10, with higher scores indicating greater unpleasantness, at baseline, after each completed minute of exercise, and at the end of each session.

    Measured: Before, during and immediately after the incremental loading test and each cycling session (Days 0-3; within 5 days).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2026
  2. Study startNov 2026 (estimated)
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07882719
Sponsor's protocol ID
S72226
Acronym
AcuteBike-ICU
Status last verified
Oct 2026
First submitted
13 Oct 2026
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Individualized constant work rate bedcycling and Individualized interval bedcycling in people with Critical Illness, run by KU Leuven.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Langer Daniel (+32 16 34 71 25, daniel.langer@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average Quadriceps Muscle Activation During Bed-Cycling (time frame: During each bed-cycling session (Days 1-3; within a maximum of 5 days).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.

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