Locomotor Muscle Oxygenation and Activation During Acute Interval Compared to Constant-load Bed-cycling Exercise

NCT05279547 | Recruiting

• 1 other identifier: S65934
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Intensive Care Unit Acquired Weakness; Critical Illness

Keywords

ICU acquired muscle weakness; Quadriceps muscle; Near-infrared spectroscopy; Oxygenation; EMG; Early-mobilization; Bed-cycling; Interval exercise; Continuous exercise

Outcome Measures

Primary Outcomes (6)

• Differences between bed-cycling protocols in fractional oxygen saturation (StiO2,%) for each measured region of the m. quadriceps femoris

  Assessed by near-infrared spectroscopy

  constant-load and interval bed-cycling protocols administered in 2 different days within 1 week

• Differences between bed-cycling protocols in activation (sEMG amplitude) for each measured region of the muscle quadriceps femoris

  Assessed by surface electromyography

  constant-load and interval bed-cycling protocols administered in 2 different days within 1 week

• Adverse event rate during constant-load bed-cycling

  Constant-load bed-cycling protocol will be considered as a safe intervention in case the adverse event rate will be less than 2.6%; adverse events: catheter/tube removal, increase in vasoactive medications \>5mcg/min, increase in systolic blood pressure \> 200 mmHg for \> 2min, decrease in mean arterial pressure \< 60 mmHg for \> 2 min, decrease in heart rate \< 50 bpm for \> 2 min, increase in heart rate \> 140 beats per minute for \> 2 min, increase in respiratory rate and sustained \> 5 min after session, decrease in peripheral capillary oxygen saturation \< 88% for \> 1 min requiring an increase in fraction of inspired oxygen \> 0.1 sustained \> 5 min)

  1 session of maximal 20 minutes of constant-load bed-cycling per patient

• Adverse event rate during interval bed-cycling

  Interval bed-cycling protocol will be considered as a safe intervention in case the adverse event rate will be less than 2.6%; adverse events: catheter/tube removal, increase in vasoactive medications \>5mcg/min, increase in systolic blood pressure \> 200 mmHg for \> 2min, decrease in mean arterial pressure \< 60 mmHg for \> 2 min, decrease in heart rate \< 50 bpm for \> 2 min, increase in heart rate \> 140 beats per minute for \> 2 min, increase in respiratory rate and sustained \> 5 min after session, decrease in peripheral capillary oxygen saturation \< 88% for \> 1 min requiring an increase in fraction of inspired oxygen \> 0.1 sustained \> 5 min)

  1 session of maximal 20 minutes of interval bed-cycling per patient

• Percentage of completed constant-load bed-cycling sessions

  The constant-load bed-cycling is deemed to be feasible if at least 80% of planned constant-load sessions were able to be commenced and 80% of commenced sessions can be completed

  1 session of maximal 20 minutes of constant-load bed-cycling per patient

• Percentage of completed interval bed-cycling sessions

  The interval bed-cycling is deemed to be feasible if at least 80% of planned interval sessions were able to be commenced and 80% of commenced sessions can be completed

  1 session of maximal 20 minutes of interval bed-cycling per patient

Secondary Outcomes (10)

• Differences in Relative dispersion (RD) of fractional oxygen saturation (StiO2,%) among the different regions of quadriceps femoris as indicator of heterogeneity of fractional oxygen extraction among different regions of quadriceps femoris muscle.

  1 session constant-load bed-cycling + 1 interval bed-cycling session administered in 2 different days within 1 week.

• Differences between exercise protocols in oxygenated hemoglobin/myoglobin (OxyHb/Mb), deoxygenated hemoglobin/myoglobin (DeoxyHb/Mb) and total hemoglobin/myoglobin concentration (TotHb/Mb) for each measured region of quadriceps femoris

  1 session constant-load bed-cycling + 1 interval bed-cycling session administered in 2 different days within 1 week.

• Differences in Median frequency of sEMG of different regions of quadriceps femoris

  1 session constant-load bed-cycling + 1 interval bed-cycling session administered in 2 different days within 1 week.

• Differences in relative dispersion (RD) of sEMG values among the different regions of quadriceps femoris as indicator of heterogeneity of activation among different regions of quadriceps femoris muscle.

  1 session constant-load bed-cycling + 1 interval bed-cycling session administered in 2 different days within 1 week.

• Differences between bed-cycling protocols in heart rate

  constant-load and interval bed-cycling protocols administered in 2 different days within 1 week

Study Arms (2)

Arm 1 (First constant-load then interval bed-cycling protocol)

ACTIVE COMPARATOR

During Day 1, patients will be familiarized with the constant-load and interval bed-cycling exercise against no resistance. Patients will be also randomized in the two arms of the study before the determination of the appropriate exercise intensities to be subsequently use during the constant-load and interval bed-cycling protocols on Day 2 and Day 3. Exercise intensities will be determined so that the volume of training during the two protocols will be equal. During Day 2, patients randomized to arm 1 will perform the constant-load bed-cycling protocol. During Day 3, patients who executed the constant-load bed-cycling protocol on Day 1 (arm 1) will perform the interval bed-cycling protocol.

Other: Constant-load bed-cycling exercise; Other: Interval bed-cycling exercise

Arm 2 (First interval then constant-load bed-cycling protocol)

ACTIVE COMPARATOR

During Day 1, patients will be familiarized with the constant-load and interval bed-cycling exercise against no resistance. Patients will be also randomized in the two arms of the study before the determination of the appropriate exercise intensities to be subsequently use during the constant-load and interval bed-cycling protocols on Day 2 and Day 3. Exercise intensities will be determined so that the volume of training during the two protocols will be equal. During Day 2, patients randomized to arm 2 will perform the interval bed-cycling protocol. On Day 3 they will perform the constant-load bed-cycling protocol.

Other: Constant-load bed-cycling exercise; Other: Interval bed-cycling exercise

Interventions

Constant-load bed-cycling exercise OTHER

Patients will actively cycle for a minimum duration of 10 minutes and a maximum duration of 20 minutes without breaks.

Arm 1 (First constant-load then interval bed-cycling protocol); Arm 2 (First interval then constant-load bed-cycling protocol)

Interval bed-cycling exercise OTHER

Patients will cycle for the same duration as during constant-load exercise. Interval bed-cycling session will consist of 30 seconds of high intensity exercise alternated by 30 seconds of passive cycling designed so that volume of training will be equal.

Arm 1 (First constant-load then interval bed-cycling protocol); Arm 2 (First interval then constant-load bed-cycling protocol)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 may not qualify 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
• Temperature \> 40 °C
• An anticipated fatal outcome
• Evidence of coronary ischaemia, for example, chest pain or electrocardiogram changes
• Resting heart rate \<40 or \>120 beats per minute
• Mean arterial pressure \<60 or \>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

Sponsors & Collaborators

• KU Leuven: lead
• Universitaire Ziekenhuizen KU Leuven: collaborator

Study Sites (1)

University Hospital Leuven

Leuven, 3000, Belgium

RECRUITING

Related Publications (7)

• Anekwe DE, Biswas S, Bussieres A, Spahija J. Early rehabilitation reduces the likelihood of developing intensive care unit-acquired weakness: a systematic review and meta-analysis. Physiotherapy. 2020 Jun;107:1-10. doi: 10.1016/j.physio.2019.12.004. Epub 2019 Dec 19.

  PMID: 32135387 BACKGROUND

• Clarissa C, Salisbury L, Rodgers S, Kean S. Early mobilisation in mechanically ventilated patients: a systematic integrative review of definitions and activities. J Intensive Care. 2019 Jan 17;7:3. doi: 10.1186/s40560-018-0355-z. eCollection 2019.

  PMID: 30680218 BACKGROUND

• Supinski GS, Valentine EN, Netzel PF, Schroder EA, Wang L, Callahan LA. Does Standard Physical Therapy Increase Quadriceps Strength in Chronically Ventilated Patients? A Pilot Study. Crit Care Med. 2020 Nov;48(11):1595-1603. doi: 10.1097/CCM.0000000000004544.

  PMID: 32826429 BACKGROUND

• Grunow JJ, Goll M, Carbon NM, Liebl ME, Weber-Carstens S, Wollersheim T. Differential contractile response of critically ill patients to neuromuscular electrical stimulation. Crit Care. 2019 Sep 10;23(1):308. doi: 10.1186/s13054-019-2540-4.

  PMID: 31506074 BACKGROUND

• Reid JC, Clarke F, Cook DJ, Molloy A, Rudkowski JC, Stratford P, Kho ME. Feasibility, Reliability, Responsiveness, and Validity of the Patient-Reported Functional Scale for the Intensive Care Unit: A Pilot Study. J Intensive Care Med. 2020 Dec;35(12):1396-1404. doi: 10.1177/0885066618824534. Epub 2019 Jan 22.

  PMID: 30669936 BACKGROUND

• Hoffman M, Clerckx B, Janssen K, Segers J, Demeyere I, Frickx B, Merckx E, Hermans G, Van der Meulen I, Van Lancker T, Ceulemans N, Van Hollebeke M, Langer D, Gosselink R. Early mobilization in clinical practice: the reliability and feasibility of the 'Start To Move' Protocol. Physiother Theory Pract. 2022 Jul;38(7):908-918. doi: 10.1080/09593985.2020.1805833. Epub 2020 Aug 31.

  PMID: 32866055 BACKGROUND

• Nickels MR, Aitken LM, Barnett AG, Walsham J, McPhail SM. Acceptability, safety, and feasibility of in-bed cycling with critically ill patients. Aust Crit Care. 2020 May;33(3):236-243. doi: 10.1016/j.aucc.2020.02.007. Epub 2020 Apr 18.

  PMID: 32317212 BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel Langer, Prof. Dr.

  KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Langer, Prof. Dr.

CONTACT

003216376497; daniel.langer@kuleuven.be

Diego Poddighe

CONTACT

diego.poddighe@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr

Model Details: two arms randomized cross-over trial

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: March 15, 2022
• Study Start: February 1, 2023
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

BE (1)