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Cycling Exercise in Mechanical Ventilation

Primary Purpose

Muscle Weakness, Mechanical Ventilation Complication

Status

Completed

Phase

Not Applicable

Locations

Czechia

Study Type

Interventional

Intervention

Cycling Exercise

Conventional Physiotherapy

About this trial

This is an interventional prevention trial for Muscle Weakness focused on measuring cycling exercise, mechanically ventilated patient, muscle strength assessment, muscle weakness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospital Ostrava

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cycling Exercise

Conventional Physiotherapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03581760

First Posted

June 12, 2018

Last Updated

December 6, 2022

Sponsor

University Hospital Ostrava

1. Study Identification

Unique Protocol Identification Number

NCT03581760

Brief Title

Cycling Exercise in Mechanical Ventilation

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

May 2, 2017 (Actual)

Primary Completion Date

November 30, 2020 (Actual)

Study Completion Date

December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital Ostrava

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Muscle Weakness, Mechanical Ventilation Complication

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Masking Description

This is an open-label study, no masking model is applied.

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cycling Exercise

Arm Type

Experimental

Arm Description

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

Arm Title

Conventional Physiotherapy

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Cycling Exercise

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Conventional Physiotherapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of ventilator days

Description

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.

Time Frame

43 months

Secondary Outcome Measure Information:

Title

Muscle strength

Description

Time Frame

43 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Renáta Zoubková, PhDr.

Organizational Affiliation

University Hospital Ostrava

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Ostrava

City

Ostrava

State/Province

Moravian-Silesian Region

ZIP/Postal Code

708 52

Country

Czechia

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

The investigators have not decided to share the IPD with other researchers.

Citations:

PubMed Identifier

17133183

Citation

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.

Results Reference

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PubMed Identifier

18596631

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.

Results Reference

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PubMed Identifier

19446324

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.

Results Reference

background

PubMed Identifier

21358312

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.

Results Reference

background

PubMed Identifier

19623052

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.

Results Reference

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Cycling Exercise in Mechanical Ventilation

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