Cycling Exercise in Mechanical Ventilation

Muscle Weakness Clinical Trial

Official title:

Effect of a Cycling Exercise on Restoration of Muscle Strength in Patients Undergoing Mechanical Ventilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03581760
• Other study ID #: KARIM-08-Motomed
• Secondary ID: MH CZ - DRO-FNOs
• Status: Completed
• Phase: N/A
• Start date: May 2, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: December 2022
• Source: University Hospital Ostrava
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prolonged critical illness renders survivors with increased long-term morbidity associated with high healthcare costs. Muscle weakness and fatigue are reported as the main contributors to long-term poor functional outcomes. Emerging evidence for early mobilisation demonstrates reduction in the number of ventilator days and hospital length of stay. It has been demonstrated that daytime motoring (passive and active) can improve functional capacity in intensive care patients. The aim of the proposed study is to evaluate the effect of cycling exercise in patients on mechanical ventilation appointed to weaning process.

Description:

This prospective randomized study is being performed at the Department of Anesthesiology, Resuscitation and Intensive Care (CARIM) of the University Hospital Ostrava. All mechanically ventilated patients are followed. At the time of weaning initiation, the randomization into two groups (the study (cycling) and control group) is performed. The physiotherapy will be carried out twice a day in both groups according to the mobility protocol. The cycling exercise is performed only in the study group, once a day. Before a patient is released from the ICU, a cycling test, dynamometry test will be performed on both groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 31, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years
• ICU admission
• Mechanically ventilated for more than 5 days
• Indications for starting weaning
• Informed consent for participation

Exclusion Criteria:

• Inability to use cycling exercise: trauma or operation of lower limbs, pelvis, open abdomen, non-cooperation (qualitative and quantitative disturbance of consciousness)
• Encephalopathy (ischemic, traumatic)
• Extreme obesity (body mass index = 40)
• Anticipated survival time = 7 days
• Patient height = 1.5 m
• More than 48 hours of mechanical ventilation outside of the department

Related Conditions & MeSH terms

• Mechanical Ventilation Complication
• Muscle Weakness
• Paresis

Intervention

Other:
• Cycling Exercise
Cycling exercise will be performed in the patients once a day.
• Conventional Physiotherapy
Conventional physiotherapy will be performed in the patients twice a day.

Locations

Country	Name	City	State
Czechia	University Hospital Ostrava	Ostrava	Moravian-Silesian Region

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Ostrava

Country where clinical trial is conducted

Czechia, 

References & Publications (5)

Bailey P, Thomsen GE, Spuhler VJ, Blair R, Jewkes J, Bezdjian L, Veale K, Rodriquez L, Hopkins RO. Early activity is feasible and safe in respiratory failure patients. Crit Care Med. 2007 Jan;35(1):139-45. doi: 10.1097/01.CCM.0000251130.69568.87. — View Citation

Burtin C, Clerckx B, Robbeets C, Ferdinande P, Langer D, Troosters T, Hermans G, Decramer M, Gosselink R. Early exercise in critically ill patients enhances short-term functional recovery. Crit Care Med. 2009 Sep;37(9):2499-505. doi: 10.1097/CCM.0b013e3181a38937. — View Citation

Morris PE, Goad A, Thompson C, Taylor K, Harry B, Passmore L, Ross A, Anderson L, Baker S, Sanchez M, Penley L, Howard A, Dixon L, Leach S, Small R, Hite RD, Haponik E. Early intensive care unit mobility therapy in the treatment of acute respiratory failure. Crit Care Med. 2008 Aug;36(8):2238-43. doi: 10.1097/CCM.0b013e318180b90e. — View Citation

Morris PE, Griffin L, Berry M, Thompson C, Hite RD, Winkelman C, Hopkins RO, Ross A, Dixon L, Leach S, Haponik E. Receiving early mobility during an intensive care unit admission is a predictor of improved outcomes in acute respiratory failure. Am J Med Sci. 2011 May;341(5):373-7. doi: 10.1097/MAJ.0b013e31820ab4f6. — View Citation

Schweickert WD, Pohlman MC, Pohlman AS, Nigos C, Pawlik AJ, Esbrook CL, Spears L, Miller M, Franczyk M, Deprizio D, Schmidt GA, Bowman A, Barr R, McCallister KE, Hall JB, Kress JP. Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial. Lancet. 2009 May 30;373(9678):1874-82. doi: 10.1016/S0140-6736(09)60658-9. Epub 2009 May 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of ventilator days	The influence of cycling exercises on the number of ventilator days will be assessed in the patients. The number of ventilator days will be compared in both groups of patients.	43 months
Secondary	Muscle strength	Muscle strength will be assessed in the mechanically ventilated patients in both groups on the Medical Research Council Manual Muscle Testing scale. This muscle scale grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle; the higher the measured value, the bigger the muscle strength and vice versa.	43 months