Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-29 @ 4:04 PM
Study NCT ID:
NCT03267212
Status:
COMPLETED
Last Update Posted:
2020-04-09
First Post:
2017-08-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Acute Effect of Ventilatory Support During Exercise in Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D063087', 'term': 'Noninvasive Ventilation'}], 'ancestors': [{'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jandrew_taylor@hms.harvard.edu', 'phone': '6177585503', 'title': 'Dr J. Andrew Taylor', 'organization': 'Harvard Medical School'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The repeatability of maximal incremental exercise tests is difficult in Spinal cord injury, increasing the variability of the measure. Higher number of participants will be necessary to study the effect of NIV on the aerobic capacity.'}}, 'adverseEventsModule': {'timeFrame': '20 months', 'description': 'This study was investigating the effect of an additional tool to help respiratory function during a single session of exercise. Adverse events has been collected during the whole period of the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Non-invasive Ventilation', 'description': 'Volunteers performed a maximal FES-row tests with Non-invasive Ventilation Support', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham Ventilation', 'description': 'Volunteers performed a maximal FES-row tests with Sham-NIV', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Peak Aerobic Capacity During FES-row Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-invasive Ventilation', 'description': 'Volunteers performed a maximal FES-row tests with Non-invasive Ventilation Support'}, {'id': 'OG001', 'title': 'Sham Ventilation', 'description': 'Volunteers performed a maximal FES-row tests with Sham-NIV'}], 'classes': [{'categories': [{'measurements': [{'value': '1.83', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '1.82', 'spread': '0.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0 and Day 2', 'description': 'Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV', 'unitOfMeasure': 'L/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '10 subjects completed both NIV and Sham tests'}, {'type': 'SECONDARY', 'title': 'Change in Cardiac Output During FES-row Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-invasive Ventilation', 'description': 'Volunteers performed a maximal FES-row tests with Non-invasive Ventilation Support'}, {'id': 'OG001', 'title': 'Sham Ventilation', 'description': 'Volunteers performed a maximal FES-row tests with Sham-NIV'}], 'classes': [{'categories': [{'measurements': [{'value': '9.6', 'groupId': 'OG000'}, {'value': '10.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 and Day 2', 'description': 'Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV', 'unitOfMeasure': 'L/min', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to technical issues, only one participant could perform both tests (NIV and sham) for this outcome'}, {'type': 'SECONDARY', 'title': 'Change in Minute Ventilation During FES-row Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-invasive Ventilation', 'description': 'Volunteers performed a maximal FES-row tests with Non-invasive Ventilation Support'}, {'id': 'OG001', 'title': 'Sham Ventilation', 'description': 'Volunteers performed a maximal FES-row tests with Sham-NIV'}], 'classes': [{'categories': [{'measurements': [{'value': '38.8', 'spread': '9.6', 'groupId': 'OG000'}, {'value': '40.3', 'spread': '10.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0 and Day 2', 'description': 'Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV', 'unitOfMeasure': 'L/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed both NIV and sham tests'}, {'type': 'SECONDARY', 'title': 'Change in Tidal Volume During FES-row Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Non-invasive Ventilation', 'description': 'Volunteers performed a maximal FES-row tests with Non-invasive Ventilation Support'}, {'id': 'OG001', 'title': 'Sham Ventilation', 'description': 'Volunteers performed a maximal FES-row tests with Sham-NIV'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0 and Day 2', 'description': 'Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed both NIV and sham tests'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Non-invasive Ventilation First, Then Sham Ventilation', 'description': 'All subjects performed FES-row testing while receiving bi-level positive airway pressure ventilation first and then Sham ventilation applied through a full face-mask.\n\nNon-invasive ventilation(NIV): The ventilator was set in spontaneous mode with a ramp to reach a minimal pressure of 12 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.\n\nSham Non-invasive ventilation(NIV): The ventilator was set in spontaneous mode with a ramp to reach a maximal pressure of 5 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.\n\nFunctional Electrical Stimulation Row Training (FESRT): FESRT couples volitional arm and electrically controlled leg exercise to allow whole body exercise training'}, {'id': 'FG001', 'title': 'Sham Ventilation First, Then Non-invasive Ventilation', 'description': 'All subjects performed FES-row testing while receiving Sham bi-level positive airway pressure ventilation first and then true ventilation applied through a full face-mask.\n\nNon-invasive ventilation(NIV): The ventilator was set in spontaneous mode with a ramp to reach a minimal pressure of 12 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.\n\nSham Non-invasive ventilation(NIV): The ventilator was set in spontaneous mode with a ramp to reach a maximal pressure of 5 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.\n\nFunctional Electrical Stimulation Row Training (FESRT): FESRT couples volitional arm and electrically controlled leg exercise to allow whole body exercise training'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Non-invasive ventilation', 'groupId': 'FG000', 'numSubjects': '6'}, {'comment': '"First Intervention (1 day)", "Washout (2 days)", and "Second Intervention (1 day)"', 'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'High SCI', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Low SCI', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Washout (Min 2 Days / Max 7 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Non-invasive Ventilation(NIV) vs. Sham Ventilation', 'description': 'All subjects performed FES-row testing while receiving bi-level positive airway pressure ventilation (or Sham ventilation) applied through a full face-mask. The tests were performed in a random order.\n\nNon-invasive ventilation(NIV): The ventilator was set in spontaneous mode with a ramp to reach a minimal pressure of 12 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.\n\nSham Non-invasive ventilation(NIV): The ventilator was set in spontaneous mode with a ramp to reach a maximal pressure of 5 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.\n\nFunctional Electrical Stimulation Row Training (FESRT): FESRT couples volitional arm and electrically controlled leg exercise to allow whole body exercise training'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000', 'lowerLimit': '21', 'upperLimit': '70'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '37'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg/m2', 'dispersionType': 'FULL_RANGE'}], 'populationDescription': 'Fifteen participants with SCI of American Spinal Injury Association Grade A or B or C, aged 40 (21 - 70) years and with a BMI of 27.2 kg/m2 (18-37). All participants were Not Hispanic or Latino but one participant had an unknown ethnicity. All participants were white but one participant was Black or African American.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-10-17', 'size': 155052, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-01-22T10:27', 'hasProtocol': True}, {'date': '2017-10-17', 'size': 166801, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-01-22T10:28', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "Investigators and technicians helping for performing the test and encouraging the patient will be blind. Only one investigator will monitor the ventilation during the test and won't be blind but won't be participating to any encouragement or data acquisition."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-31', 'studyFirstSubmitDate': '2017-08-22', 'resultsFirstSubmitDate': '2020-01-30', 'studyFirstSubmitQcDate': '2017-08-28', 'lastUpdatePostDateStruct': {'date': '2020-04-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-16', 'studyFirstPostDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Peak Aerobic Capacity During FES-row Testing', 'timeFrame': 'Day 0 and Day 2', 'description': 'Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV'}], 'secondaryOutcomes': [{'measure': 'Change in Cardiac Output During FES-row Testing', 'timeFrame': 'Day 0 and Day 2', 'description': 'Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV'}, {'measure': 'Change in Minute Ventilation During FES-row Testing', 'timeFrame': 'Day 0 and Day 2', 'description': 'Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV'}, {'measure': 'Change in Tidal Volume During FES-row Testing', 'timeFrame': 'Day 0 and Day 2', 'description': 'Volunteers performed 2 separate maximal FES-row tests, one with Non-invasive Ventilation Support and one with Sham-NIV'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Functional Electrical Stimulation (FES)-Rowing', 'Ventilatory support'], 'conditions': ['Spinal Cord Injury']}, 'referencesModule': {'references': [{'pmid': '31738927', 'type': 'DERIVED', 'citation': 'Vivodtzev I, Picard G, Cepeda FX, Taylor JA. Acute Ventilatory Support During Whole-Body Hybrid Rowing in Patients With High-Level Spinal Cord Injury: A Randomized Controlled Crossover Trial. Chest. 2020 May;157(5):1230-1240. doi: 10.1016/j.chest.2019.10.044. Epub 2019 Nov 16.'}]}, 'descriptionModule': {'briefSummary': 'The investigators have an existing exercise program (N\\>70) with a unique population of individuals with spinal cord injury (SCI) who have been enrolled in Functional Electrical Stimulation - Rowing Training (FES-RT) for at least 6 months. Previous data in the laboratory from this exercise platform has recently showed that respiratory restriction in SCI reduces inspiratory capacity in direct relation to lesion level, and those with high level injuries have the greatest compromise. As a result, the increase in ventilatory requirements with FES training results in an imbalance between ventilatory capacity and greater whole body skeletal muscle demand after FES rowing training. Hence, external ventilatory support could improve the ability to exercise train and hence enhance the adaptations to chronic exercise in high level SCI. If our hypothesis is correct, this indicates that maximal aerobic capacity in these individuals exceeds maximal voluntary ventilation. It will be important to determine however the consistency of this response and at what level of injury it is not observed. In parallel of the study # NCT02865343, the investigators will recruit here a population of subjects who have completed six months of FES-row exercise training across a range of SCI level (C5-T12). Hence, the investigators will be able to determine the consistency of the effect and the dependence of the effect on SCI level. Some of them with level \\>T3 may also enroll in training effect study with NIV or sham NIV (NCT02865343))', 'detailedDescription': 'Regular aerobic exercise with sufficient intensity can improve overall health, however daily energy expenditure is low in those with SCI, especially in those with high level lesions. The investigators have developed Functional Electrical Stimulation Row Training (FESRT) that couples volitional arm and electrically controlled leg exercise, increasing the active muscle and resulting in benefits of large muscle mass exercise. Despite the potential for enhancing aerobic capacity, those with high level lesions (C4 to T2) have a remaining obstacle to attaining higher work capacities. They have the greatest pulmonary muscle denervation and our preliminary work suggests this limits the aerobic capacity that can be achieved with FESRT. External ventilatory support could improve the ability to reach higher level of peak ventilation and hence enhance the ability to exercise in high level SCI. Therefore, the investigators hypothesize that the use of NIV during FESRT will reduce ventilatory limits to exercise, leading to increased aerobic capacity in high level SCI. The aims are to examine the acute effect of NIV on FES-row VO2max in subjects with both high and low level SCI. The investigators have access to a large (N\\>70) and unique population of individuals with SCI who have been enrolled in FESRT for at least 6 months. Roughly half have SCI between C4 and T2 and half with lower injury levels (\\<T3). 15 individuals who have FES row trained for at least 6 months will perform FES-VO2max row tests on separate days with and without the use of NIV to determine maximal aerobic capacity and ventilation. Both FES-VO2max Row tests will be performed at least 48-hours apart. Both tests will be performed with the NIV set-up but with and without use of the NIV support in a random order. The level of inspiratory pressure will be individually set during a familiarization test. The investigators will assess maximal aerobic capacity, minute ventilation, tidal volume and cardiac output during FES-rowing. Based on current data, it is hypothesized that only those with higher level of injury (\\> T3) will experience further increases in aerobic capacity when using the NIV support. This exploratory/developmental research project will determine feasibility and effectiveness of this approach to exercise and will lay the groundwork for a larger, controlled trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects aged 18 to 70 (IRB amendment to change maximal age from 60 to 70 years old approved on 9/20/17)\n* Have had SCI (at neurological level C5-T12 with American Spinal Injury Association grade A or B or C)\n* Medically stable\n* Have FES-row trained for \\>6 months\n\nExclusion Criteria:\n\n* Hypertension(Blood pressure\\>140/90 mmHg)\n* Significant arrhythmias\n* Coronary disease\n* Chronic respiratory disease\n* Diabetes\n* Renal disease\n* Cancer\n* Epilepsy\n* Current use of cardioactive medications\n* Current grade 2 or greater pressure ulcers at relevant contact sites\n* Other neurological disease\n* Peripheral nerve compression or rotator cuff tears that limit the ability to row\n* History of bleeding disorder'}, 'identificationModule': {'nctId': 'NCT03267212', 'acronym': 'NIV-Ex-CS', 'briefTitle': 'Acute Effect of Ventilatory Support During Exercise in Spinal Cord Injury', 'organization': {'class': 'OTHER', 'fullName': 'Spaulding Rehabilitation Hospital'}, 'officialTitle': 'Acute Effect of Ventilatory Support During Exercise in Spinal Cord Injury', 'orgStudyIdInfo': {'id': 'SpauldingRH-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Non-invasive Ventilation(NIV)', 'description': 'Subjects will perform FES-row testing while receiving bi-level positive airway pressure ventilation applied through a full face-mask.', 'interventionNames': ['Device: Non-invasive ventilation(NIV)', 'Other: Functional Electrical Stimulation Row Training (FESRT)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Non-invasive ventilation(NIV)', 'description': 'Subjects will perform FES-row testing while receiving sham ventilation applied through a full face-mask.', 'interventionNames': ['Device: Sham Non-invasive ventilation(NIV)', 'Other: Functional Electrical Stimulation Row Training (FESRT)']}], 'interventions': [{'name': 'Non-invasive ventilation(NIV)', 'type': 'DEVICE', 'description': 'The ventilator will be set in spontaneous mode with a ramp to reach a minimal pressure of 12 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.', 'armGroupLabels': ['Non-invasive Ventilation(NIV)']}, {'name': 'Sham Non-invasive ventilation(NIV)', 'type': 'DEVICE', 'description': 'The ventilator will be set in spontaneous mode with a ramp to reach a maximal pressure of 5 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.', 'armGroupLabels': ['Sham Non-invasive ventilation(NIV)']}, {'name': 'Functional Electrical Stimulation Row Training (FESRT)', 'type': 'OTHER', 'description': 'FESRT couples volitional arm and electrically controlled leg exercise to allow whole body exercise training', 'armGroupLabels': ['Non-invasive Ventilation(NIV)', 'Sham Non-invasive ventilation(NIV)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02138', 'city': 'Cambridge', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Spaulding Hospital Cambridge', 'geoPoint': {'lat': 42.3751, 'lon': -71.10561}}], 'overallOfficials': [{'name': 'J. Andrew Taylor, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Spaulding Rehabilitation Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spaulding Rehabilitation Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'J. Andrew Taylor', 'investigatorAffiliation': 'Spaulding Rehabilitation Hospital'}}}}