Cycling Exercise in Mechanical Ventilation

NCT03581760 | Completed

• 2 other identifiers: KARIM-08-MotomedMH CZ - DRO-FNOs/2017
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Muscle Weakness; Mechanical Ventilation Complication

Keywords

cycling exercise; mechanically ventilated patient; muscle strength assessment; muscle weakness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Muscle strength

  43 months

Study Arms (2)

Cycling Exercise

EXPERIMENTAL

Patients randomized into this arm will undergo cycling exercise once a day while on mechanical ventilation at intensive care unit.

Other: Cycling Exercise; Other: Conventional Physiotherapy

Conventional Physiotherapy

ACTIVE COMPARATOR

Patients randomized into this arm will undergo conventional physiotherapy twice a day while on mechanical ventilation at intensive care unit.

Other: Conventional Physiotherapy

Interventions

Cycling Exercise OTHER

Cycling exercise will be performed in the patients once a day.

Cycling Exercise

Conventional Physiotherapy OTHER

Conventional physiotherapy will be performed in the patients twice a day.

Conventional Physiotherapy; Cycling Exercise

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 708 52, Czechia

Location

Related 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.

  PMID: 17133183 BACKGROUND

• 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.

  PMID: 18596631 BACKGROUND

• 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.

  PMID: 19446324 BACKGROUND

• 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.

  PMID: 21358312 BACKGROUND

• 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.

  PMID: 19623052 BACKGROUND

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Renáta Zoubková, PhDr.

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study, no masking model is applied.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients enrolled in the study will be randomized into two groups - active intervention and control group.

Study Record Dates

• First Submitted: June 12, 2018
• First Posted: July 10, 2018
• Study Start: May 2, 2017
• Primary Completion: November 30, 2020
• Study Completion: December 31, 2020
• Last Updated: December 7, 2022

Record last verified: 2022-12

Locations

CZ (1)