Ignite Creation Date:
2025-12-24 @ 2:02 PM
Ignite Modification Date:
2026-02-25 @ 6:43 PM
Study NCT ID:
NCT03709095
Status:
COMPLETED
Last Update Posted:
2018-10-17
First Post:
2018-10-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sprint Interval Training During Rehabilitation After Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072696', 'term': 'High-Intensity Interval Training'}], 'ancestors': [{'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants were randomized to one of two groups: (A) sprint interval training (SIT) or (B) moderate intensity continuous training (MICT).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-15', 'studyFirstSubmitDate': '2018-10-11', 'studyFirstSubmitQcDate': '2018-10-15', 'lastUpdatePostDateStruct': {'date': '2018-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in peak power output', 'timeFrame': 'Change in peak power output from baseline to 5 weeks', 'description': 'maximum amount of power produced during a graded exercise test on the arm-ergometer'}, {'measure': 'Change in sub-maximal arm-ergometry', 'timeFrame': 'Change in sub-maximal arm-ergometry from baseline to 5 weeks', 'description': "Participants performed three 5-minute steady state workloads on the arm-ergometer at power outputs corresponding to RPE's of 8, 10 and 12. Participants were given a minimum of 2 minutes, and a maximum of 5 minutes of rest in between each workload."}], 'secondaryOutcomes': [{'measure': 'Cardiovascular Responses', 'timeFrame': 'Throughout each week of training (Week 1,Week 2, Week 3, Week4, Week 5)', 'description': 'Monitored heart rate throughout each training session'}, {'measure': 'Perceptual Responses', 'timeFrame': 'Throughout each week of training (Week 1,Week 2, Week 3, Week4, Week 5)', 'description': 'Monitored ratings of perceived exertion throughout each training session'}, {'measure': 'Change in self-efficacy for exercise', 'timeFrame': 'Change in self-efficacy from baseline to 5 weeks', 'description': 'Using a self-reported questionnaire, participants rated how confident they are with regards to performing and carrying out regular physical activities and exercises.'}, {'measure': 'Exercise Satisfaction', 'timeFrame': 'Measured only at the end of the intervention (5 weeks)', 'description': 'Participants completed the Physical Activity Enjoyment Scale (PACES) in order to asses the level of enjoyment with the training intervention they received.'}, {'measure': 'Pain perceptions', 'timeFrame': 'Measured only at the end of the intervention (5 weeks)', 'description': 'Through a questionnaire, participants rated how much shoulder pain, bodily pain, and physical discomfort they typically experience throughout the day and how much pain they experienced with the intervention they were allocated to.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Inpatient Rehabilitation', 'Sprint interval training', 'Exercise', 'Spinal Cord Injury'], 'conditions': ['Spinal Cord Injuries', 'Rehabilitation', 'Exercise']}, 'referencesModule': {'references': [{'pmid': '27115137', 'type': 'BACKGROUND', 'citation': 'Gillen JB, Martin BJ, MacInnis MJ, Skelly LE, Tarnopolsky MA, Gibala MJ. Twelve Weeks of Sprint Interval Training Improves Indices of Cardiometabolic Health Similar to Traditional Endurance Training despite a Five-Fold Lower Exercise Volume and Time Commitment. PLoS One. 2016 Apr 26;11(4):e0154075. doi: 10.1371/journal.pone.0154075. eCollection 2016.'}, {'pmid': '12494319', 'type': 'BACKGROUND', 'citation': 'Hicks AL, Martin KA, Ditor DS, Latimer AE, Craven C, Bugaresti J, McCartney N. Long-term exercise training in persons with spinal cord injury: effects on strength, arm ergometry performance and psychological well-being. Spinal Cord. 2003 Jan;41(1):34-43. doi: 10.1038/sj.sc.3101389.'}, {'pmid': '28089898', 'type': 'BACKGROUND', 'citation': 'Nightingale TE, Metcalfe RS, Vollaard NB, Bilzon JL. Exercise Guidelines to Promote Cardiometabolic Health in Spinal Cord Injured Humans: Time to Raise the Intensity? Arch Phys Med Rehabil. 2017 Aug;98(8):1693-1704. doi: 10.1016/j.apmr.2016.12.008. Epub 2017 Jan 13.'}, {'pmid': '27930890', 'type': 'BACKGROUND', 'citation': 'Astorino TA, Thum JS. Within-session responses to high-intensity interval training in spinal cord injury. Disabil Rehabil. 2018 Feb;40(4):444-449. doi: 10.1080/09638288.2016.1260648. Epub 2016 Dec 8.'}]}, 'descriptionModule': {'briefSummary': 'Immediately following a spinal cord injury (SCI), patients are admitted to inpatient rehabilitation where they undergo physical reconditioning in preparation for a return to home setting. The current standard of practice for aerobic training is performing arm-ergometry for 25 mins at a frequency of three times per week. Given the move towards shortened length of stay during inpatient rehabilitation, performing MICT can consume a considerable amount of therapy time. Sprint interval training (SIT) has been shown to elicit similar improvements in physical capacity, despite a reduced time commitment to MICT. However, there are no controlled trials comparing the effects of SIT to MICT in individuals with SCI undergoing inpatient rehabilitation. The primary aim of this study was to investigate the efficacy of a five-week, thrice weekly 10 min SIT program and compare outcome measures to a traditional 25 minute MICT program on the arm-ergometer in individuals with SCI undergoing inpatient clinical rehabilitation. It was hypothesized that five weeks of SIT and MICT would induce similar changes in maximal and sub-maximal exercise performance, self-efficacy for exercise, and exercise enjoyment, despite large differences in training volume and time commitment. It was also hypothesized that SIT would be well tolerated and elicit higher levels of cardiovascular strain than MICT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants with sub-acute spinal cord injury (time since injury: 14 - 182 days)\n* Undergoing inpatient rehabilitation\n* Aged 18-65 years\n* Injury level at the second cervical vertebrae (C2) or below\n\nExclusion Criteria:\n\n\\- Unable to perform arm-ergometry training'}, 'identificationModule': {'nctId': 'NCT03709095', 'acronym': 'SprintSCI', 'briefTitle': 'Sprint Interval Training During Rehabilitation After Spinal Cord Injury', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'Sprint Interval Training During Rehabilitation After Spinal Cord Injury', 'orgStudyIdInfo': {'id': 'SprintSCI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Moderate Intensity Continuous Training', 'description': 'Training was performed three times a week for five weeks. Each session began with a 2 minute warm up, and concluded with a 3 minute cool down. Following the warm-up, participants performed 20 minutes of arm cycling at a self-selected cadence at 45-65% of their peak power output. Total training duration was 25 mins.', 'interventionNames': ['Other: moderate intensity continuous training']}, {'type': 'EXPERIMENTAL', 'label': 'Sprint Interval Training', 'description': 'The SIT protocol was adopted from Gillen and colleagues (See Ref), and consisted of 3 x 20 second "all-out" efforts at ≥ 100% of an individuals peak power output. Each sprint was interspersed by 120 seconds of active recovery at 10% of an individuals peak power output. Total training duration was 10 mins.', 'interventionNames': ['Other: Sprint interval training']}], 'interventions': [{'name': 'Sprint interval training', 'type': 'OTHER', 'description': 'Participants utilized the arm ergometer for improving aerobic exercise capacity', 'armGroupLabels': ['Sprint Interval Training']}, {'name': 'moderate intensity continuous training', 'type': 'OTHER', 'description': 'Participants utilized the arm ergometer for improving aerobic exercise capacity', 'armGroupLabels': ['Moderate Intensity Continuous Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8S 4L8', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'McMaster University', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'overallOfficials': [{'name': 'Audrey L Hicks, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McMaster University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hamilton Health Sciences Corporation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}