Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT03545867
Status:
COMPLETED
Last Update Posted:
2020-06-19
First Post:
2018-05-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Energetic Response to Feeding and Exercise in SCI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'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': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'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': 'PREVENTION', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Static first arm with randomized remaining three arms.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-17', 'studyFirstSubmitDate': '2018-05-22', 'studyFirstSubmitQcDate': '2018-05-22', 'lastUpdatePostDateStruct': {'date': '2020-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postprandial insulin sensitivity', 'timeFrame': '2.5 hr', 'description': 'Measured by insulin incremental area under the curve (iAUC).'}, {'measure': 'Postprandial insulin sensitivity', 'timeFrame': '2.5 hr', 'description': 'Measured by "ISIMatsuada" insulin sensitivity index. This index is calculated based on the ratio of blood glucose and insulin.'}], 'secondaryOutcomes': [{'measure': 'Lipemia', 'timeFrame': '2.5 hr', 'description': 'Measured by blood concentrations of triglycerides.'}, {'measure': 'Carbohydrate use', 'timeFrame': '2.5 hr', 'description': 'Whole-body rates of carbohydrate oxidation, as determined by open-circuit indirect calorimetry.'}, {'measure': 'Fat use', 'timeFrame': '2.5 hr', 'description': 'Whole-body rates of fat oxidation, as determined by open-circuit indirect calorimetry.'}, {'measure': 'Fasted insulin sensitivity', 'timeFrame': 'Baseline', 'description': 'Measured by "HOMA-2" model. This model is calculated based on the ratio of blood glucose and insulin.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['postprandial', 'glycemia', 'lipemia', 'macronutrient metabolism', 'physical activity'], 'conditions': ['Spinal Cord Injuries']}, 'referencesModule': {'references': [{'pmid': '33433151', 'type': 'DERIVED', 'citation': 'McMillan DW, Maher JL, Jacobs KA, Mendez AJ, Nash MS, Bilzon JLJ. Effects of Exercise Mode on Postprandial Metabolism in Humans with Chronic Paraplegia. Med Sci Sports Exerc. 2021 Jul 1;53(7):1495-1504. doi: 10.1249/MSS.0000000000002593.'}, {'pmid': '31409383', 'type': 'DERIVED', 'citation': 'McMillan DW, Maher JL, Jacobs KA, Mendez AJ, Nash MS, Bilzon JLJ. Influence of upper-body continuous, resistance or high-intensity interval training (CRIT) on postprandial responses in persons with spinal cord injury: study protocol for a randomised controlled trial. Trials. 2019 Aug 13;20(1):497. doi: 10.1186/s13063-019-3583-1.'}]}, 'descriptionModule': {'briefSummary': 'This study investigates the effect of various forms of upper extremity exercise on postprandial glycemia and lipemia in persons with spinal cord injury (SCI). Participants are measured at rest and fed a standardized meal following seated rest (CON), moderate intensity continuous arm cycling (MICT), high intensity interval arm cycling (HIIT), and circuit resistance exercise (CRT) matched for exercise energy expenditure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (\\>/=18 years of age)\n* Neurologically stable chronic (\\>/= 1year) spinal cord injury (SCI)\n* American Spinal Injury Association Impairment Scale (AIS) grade A, B, or C\n* SCI at level \\</= the first thoracic vertebrae (T1)\n\nExclusion Criteria:\n\n* Being of ≤ 18 years of age.\n* Contraindication to exercise (ACSM Guideline, 10th edition)\n* Lower extremity fracture or dislocation within 6 months of participation,\n* History head injury or seizures.\n* Inability to consent.\n* Restrictions in upper extremity range of motion that would prevent an individual from achieving an unhindered arm cycling motion or moving throughout a range needed to perform resistance maneuvers.\n* A pressure ulcer at ischial/gluteus, trochanteric, sacral, or heel sites within the last 3 months.\n* Pregnancy determined by urine testing in sexually active females.\n* Imprisonment in state or federal jail or prison.'}, 'identificationModule': {'nctId': 'NCT03545867', 'acronym': 'CRIT', 'briefTitle': 'Energetic Response to Feeding and Exercise in SCI', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Effect of Various Forms of Upper Body Exercise on the Energetic Response to a Meal in Persons With Spinal Cord Injury', 'orgStudyIdInfo': {'id': '20171114'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Seated control (CON)', 'description': 'Participants remain seated in their habitual wheel chair for \\~45 min (duration of exercise performed in other arms). Following the intervention they are fed.', 'interventionNames': ['Behavioral: Seated control (CON)', 'Other: Liquid Meal']}, {'type': 'EXPERIMENTAL', 'label': 'Circuit resistance training (CRT)', 'description': 'Participants complete upper extremity resistance maneuvers (lifts) interspersed with low-load/high-speed arm cycling for a combined 30 repetitions of 6 lifts and \\~20 min of arm cycling. During this time energy expenditure is measured via open-circuit indirect calorimetry. Following the intervention they are fed.', 'interventionNames': ['Behavioral: Circuit resistance training (CRT)', 'Other: Liquid Meal']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate intensity continuous (MICT)', 'description': 'Participants complete continous arm cycling at a steady-state power output (intensity) matched to the energy expenditure (kcal/min) and duration of exercise (min) response during CRT. Following the intervention they are fed.', 'interventionNames': ['Behavioral: Moderate intensity continuous (MICT)', 'Other: Liquid Meal']}, {'type': 'EXPERIMENTAL', 'label': 'High intensity interval training (HIIT)', 'description': 'Participants complete interval arm cycling at power output that varies between 2 min "active" and two min "recovery" periods. This interval exercise is matched to the total energy expenditure (accumulated kcals) response during CRT. Following the intervention they are fed.', 'interventionNames': ['Behavioral: High intensity interval training (HIIT)', 'Other: Liquid Meal']}], 'interventions': [{'name': 'Seated control (CON)', 'type': 'BEHAVIORAL', 'description': 'Seated rest', 'armGroupLabels': ['Seated control (CON)']}, {'name': 'Moderate intensity continuous (MICT)', 'type': 'BEHAVIORAL', 'description': 'Arm cycling at a continuous power output', 'armGroupLabels': ['Moderate intensity continuous (MICT)']}, {'name': 'High intensity interval training (HIIT)', 'type': 'BEHAVIORAL', 'description': 'Arm cycling at power outputs that vary between high and low intensity intervals', 'armGroupLabels': ['High intensity interval training (HIIT)']}, {'name': 'Circuit resistance training (CRT)', 'type': 'BEHAVIORAL', 'description': 'Alternating between six upper extremity resistance maneuvers interspersed with low-resistance/high-speed arm cycling.', 'armGroupLabels': ['Circuit resistance training (CRT)']}, {'name': 'Liquid Meal', 'type': 'OTHER', 'description': 'A liquid meal consisting of 600 kcal comprised of 50% carbohydrate, 35% fat, and 15% protein (by kcal).', 'armGroupLabels': ['Circuit resistance training (CRT)', 'High intensity interval training (HIIT)', 'Moderate intensity continuous (MICT)', 'Seated control (CON)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33143', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Lois Pope Life Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Mark S Nash, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mark S. Nash, Ph.D., FACSM', 'investigatorAffiliation': 'University of Miami'}}}}