Ignite Creation Date:
2025-12-25 @ 2:33 AM
Ignite Modification Date:
2026-03-03 @ 6:05 PM
Study NCT ID:
NCT03837834
Status:
COMPLETED
Last Update Posted:
2019-09-06
First Post:
2019-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of 6 Weeks High-intensity Interval Training Among Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-09-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-05', 'studyFirstSubmitDate': '2019-02-07', 'studyFirstSubmitQcDate': '2019-02-08', 'lastUpdatePostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of peak torque of Quadriceps and Hamstring', 'timeFrame': 'Changes of peak torque at 6 week', 'description': 'Isometric peak torque for quadriceps and hamstring will be measured using Biodex isokinetic machine.'}], 'secondaryOutcomes': [{'measure': 'Changes of peak VO2', 'timeFrame': 'Changes of peak VO2 at 6 week', 'description': 'Peak VO2 will be measured using Cosmed Quark CPET system apparatus'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIGH INTENSITY INTERVAL TRAINING', 'INCOMPLETE SPINAL CORD INJURY', 'MUSCLE STRENGTH', 'CARDIO-RESPIRATORY FITNESS'], 'conditions': ['INCOMPLETE SPINAL CORD INJURY (ASIA D)']}, 'descriptionModule': {'briefSummary': "The training consists of 6 weeks of functional electrical stimulation leg cycling exercise (FES-LCE) program. The training program comprises of 2 visits per week. Each visit consists of FES-LCE for 45 minutes. Throughout the 6 weeks program, there will be testing/assessment sessions on week 1, week 3 and week 6. The FES will be applied via surface electrodes and the stimulation intensity based on the participant's tolerance level."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants were diagnosed with incomplete spinal cord injury (SCI) at least one year prior to participation.\n* Age between 18-75 years old.\n* Both male and female.\n* Have at least 90ยบ bilateral knee flexion.\n* Moderate neurological induce weakness in quadriceps muscle of 1 leg that is responsive to electrical stimulation (moderate weakness was defined as 3/5 or 4/5 on manual muscle testing).\n* Able to perform cycling activity.\n* Normal upper limb function.\n* Able to follow command.\n\nExclusion Criteria:\n\n* Had a recent history of trauma to the lower limb.\n* Severely infected skin pressure sore on weight-bearing skin areas.\n* Illness caused by acute urinary tract infection.\n* Uncontrolled spasticity or pain.\n* History of cardiovascular/cardiorespiratory problem.\n* Orthostatic hypotension.\n* Unhealed decubiti at electrode placement area.\n* Recurrent autonomic dysreflexia.\n* Active heterotopic ossification.\n* Other peripheral or central neurologic injury.'}, 'identificationModule': {'nctId': 'NCT03837834', 'briefTitle': 'Effects of 6 Weeks High-intensity Interval Training Among Spinal Cord Injury', 'organization': {'class': 'OTHER', 'fullName': 'Universiti Teknologi Mara'}, 'officialTitle': 'Effects of 6 Weeks High-intensity Interval Training on Muscle Strength and Cardiorespiratory Response Among Spinal Cord Injury', 'orgStudyIdInfo': {'id': '201682-4100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '4 MIN X 4 MIN HIIT of FES-LCE', 'description': '4 min of high-intensity phase intersperses with 4 min of low-intensity phase for a total of 5 bouts.', 'interventionNames': ['Other: Functional Electrical Stimulation Leg Cycling Exercise']}, {'type': 'EXPERIMENTAL', 'label': '2 MIN X 2 MIN HIIT of FES-LCE', 'description': '2 min of high-intensity phase intersperses with 2 min of low-intensity phase for a total of 10 bouts.', 'interventionNames': ['Other: Functional Electrical Stimulation Leg Cycling Exercise']}], 'interventions': [{'name': 'Functional Electrical Stimulation Leg Cycling Exercise', 'type': 'OTHER', 'description': 'FES- leg cycling for 45 minutes (3 min warm up + 40 min HIIT + 2 min cooldown). The FES will be applied via surface electrodes and the stimulation intensity based on your tolerance level.', 'armGroupLabels': ['2 MIN X 2 MIN HIIT of FES-LCE', '4 MIN X 4 MIN HIIT of FES-LCE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59100', 'city': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'University Malaya Medical Center', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universiti Teknologi Mara', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Malaya', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'MOHD KHAIRUL AZHAR BIN ARIFFIN', 'investigatorAffiliation': 'Universiti Teknologi Mara'}}}}