Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT03581760
Status:
COMPLETED
Last Update Posted:
2022-12-07
First Post:
2018-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cycling Exercise in Mechanical Ventilation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018908', 'term': 'Muscle Weakness'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'This is an open-label study, no masking model is applied.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients enrolled in the study will be randomized into two groups - active intervention and control group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-06', 'studyFirstSubmitDate': '2018-06-12', 'studyFirstSubmitQcDate': '2018-06-26', 'lastUpdatePostDateStruct': {'date': '2022-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of ventilator days', 'timeFrame': '43 months', '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.'}], 'secondaryOutcomes': [{'measure': 'Muscle strength', 'timeFrame': '43 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cycling exercise', 'mechanically ventilated patient', 'muscle strength assessment', 'muscle weakness'], 'conditions': ['Muscle Weakness', 'Mechanical Ventilation Complication']}, 'referencesModule': {'references': [{'pmid': '17133183', 'type': 'BACKGROUND', '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.'}, {'pmid': '18596631', 'type': 'BACKGROUND', '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.'}, {'pmid': '19446324', 'type': 'BACKGROUND', '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.'}, {'pmid': '21358312', 'type': 'BACKGROUND', '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.'}, {'pmid': '19623052', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'This prospective randomized study is being performed at the Department of Anesthesiology, Resuscitation and Intensive Care (CARIM) of the University Hospital Ostrava.\n\nAll 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* ICU admission\n* Mechanically ventilated for more than 5 days\n* Indications for starting weaning\n* Informed consent for participation\n\nExclusion Criteria:\n\n* Inability to use cycling exercise: trauma or operation of lower limbs, pelvis, open abdomen, non-cooperation (qualitative and quantitative disturbance of consciousness)\n* Encephalopathy (ischemic, traumatic)\n* Extreme obesity (body mass index ≥ 40)\n* Anticipated survival time ≤ 7 days\n* Patient height ≤ 1.5 m\n* More than 48 hours of mechanical ventilation outside of the department'}, 'identificationModule': {'nctId': 'NCT03581760', 'briefTitle': 'Cycling Exercise in Mechanical Ventilation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Ostrava'}, 'officialTitle': 'Effect of a Cycling Exercise on Restoration of Muscle Strength in Patients Undergoing Mechanical Ventilation', 'orgStudyIdInfo': {'id': 'KARIM-08-Motomed'}, 'secondaryIdInfos': [{'id': 'MH CZ - DRO-FNOs/2017', 'type': 'OTHER_GRANT', 'domain': 'Ministry of Health of the Czech Republic'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cycling Exercise', 'description': 'Patients randomized into this arm will undergo cycling exercise once a day while on mechanical ventilation at intensive care unit.', 'interventionNames': ['Other: Cycling Exercise', 'Other: Conventional Physiotherapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Physiotherapy', 'description': 'Patients randomized into this arm will undergo conventional physiotherapy twice a day while on mechanical ventilation at intensive care unit.', 'interventionNames': ['Other: Conventional Physiotherapy']}], 'interventions': [{'name': 'Cycling Exercise', 'type': 'OTHER', 'description': 'Cycling exercise will be performed in the patients once a day.', 'armGroupLabels': ['Cycling Exercise']}, {'name': 'Conventional Physiotherapy', 'type': 'OTHER', 'description': 'Conventional physiotherapy will be performed in the patients twice a day.', 'armGroupLabels': ['Conventional Physiotherapy', 'Cycling Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '708 52', 'city': 'Ostrava', 'state': 'Moravian-Silesian Region', 'country': 'Czechia', 'facility': 'University Hospital Ostrava', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}], 'overallOfficials': [{'name': 'Renáta Zoubková, PhDr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Ostrava'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The investigators have not decided to share the IPD with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Ostrava', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}