Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-24 @ 4:45 PM
Study NCT ID:
NCT04397250
Status:
UNKNOWN
Last Update Posted:
2022-07-29
First Post:
2020-05-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
High-intensity Interval Training for Cardiometabolic Health in Persons With Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010264', 'term': 'Paraplegia'}], 'ancestors': [{'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-26', 'studyFirstSubmitDate': '2020-05-17', 'studyFirstSubmitQcDate': '2020-05-20', 'lastUpdatePostDateStruct': {'date': '2022-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fasting insulin', 'timeFrame': '6 weeks', 'description': 'Serum insulin concentration'}, {'measure': 'Peak aerobic capacity', 'timeFrame': '6 weeks', 'description': 'Measured using a incremental ramp protocol on a arm crank ergometer'}, {'measure': 'Peak power output', 'timeFrame': '6 weeks', 'description': 'Maximum power output achieved during peak aerobic capacity test'}], 'secondaryOutcomes': [{'measure': 'Body mass', 'timeFrame': '6 weeks', 'description': 'Measured using electronic wheelchair scales'}, {'measure': 'Waist and hip circumference', 'timeFrame': '6 weeks', 'description': 'Measured using a non-metallic tape'}, {'measure': 'Total body fat percentage', 'timeFrame': '6 weeks', 'description': 'Measured using duel-energy x-ray absorptiometry'}, {'measure': 'Total Fat Mass', 'timeFrame': '6 weeks', 'description': 'Measured using duel-energy x-ray absorptiometry'}, {'measure': 'Total Fat-Free Mass', 'timeFrame': '6 weeks', 'description': 'Measured using duel-energy x-ray absorptiometry'}, {'measure': 'Visceral Adipose Tissue', 'timeFrame': '6 weeks', 'description': 'Measured using duel-energy x-ray absorptiometry'}, {'measure': 'Systolic and diastolic blood pressure', 'timeFrame': '6 weeks', 'description': 'Measuring using a automated sphygmomanometer'}, {'measure': 'Resting metabolic rate', 'timeFrame': '6 weeks', 'description': 'Measured using indirect calorimetry'}, {'measure': 'Time spent in different physical activity intensities (MET categories) (minutes)', 'timeFrame': '6 weeks', 'description': 'Time spent in different physical activity intensities across 7-days (MET categories) (minutes)'}, {'measure': 'Energy expended in different physical activity intensities (MET categories) (kJ or kcal)', 'timeFrame': '6 weeks', 'description': 'Energy expended in different physical activity intensities across 7-days (MET categories) (kJ or kcal)'}, {'measure': 'Energy intake and dietary macronutrient composition', 'timeFrame': '6 weeks', 'description': 'Estimated using a 7-day weighed food diary'}, {'measure': 'Fasting metabolite/hormone/inflammatory profile', 'timeFrame': '6 weeks', 'description': 'Assessment of blood glucose, glycated hemoglobin, triglycerides, non-esterified fatty acids, total cholesterol, high density lipoprotein, and low density lipoprotein concentrations, leptin, C-reactive protein, interleukin-6, tumour-necrosis factor-alpha, and adiponectin'}, {'measure': 'Postprandial metabolites', 'timeFrame': '6 weeks', 'description': 'Assessment of blood glucose and insulin'}, {'measure': 'Shoulder Pain', 'timeFrame': '6 weeks', 'description': 'Measured using a validated questionnaire'}, {'measure': 'Exercise Self-Efficacy', 'timeFrame': '6 weeks', 'description': 'Measuring using a validated questionnaire'}, {'measure': 'Health-related quality of life', 'timeFrame': '6 weeks', 'description': 'Measured using a validated questionnaire'}, {'measure': 'Fatigue', 'timeFrame': '6 weeks', 'description': 'Measured using a validated questionnaire'}, {'measure': 'Independence', 'timeFrame': '6 weeks', 'description': 'Measured using a validated questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['high-intensity interval training', 'cardiometabolic health'], 'conditions': ['Paraplegia']}, 'referencesModule': {'references': [{'pmid': '33600014', 'type': 'DERIVED', 'citation': 'Farrow MT, Maher J, Thompson D, Bilzon JLJ. Effect of high-intensity interval training on cardiometabolic component risks in persons with paraplegia: Protocol for a randomized controlled trial. Exp Physiol. 2021 May;106(5):1159-1165. doi: 10.1113/EP089110. Epub 2021 Mar 20.'}]}, 'descriptionModule': {'briefSummary': 'Persons with chronic paraplegia at an increased risk of developing cardiovascular disease and type-2 diabetes compared to the able-bodied population. There is mounting evidence from the able-bodied literature that high-intensity interval training (HIIT) is an effective way to improve cardiometabolic health outcomes, but this effect has yet to be investigated in persons with chronic paraplegia.\n\nThis study is recruiting adults (aged 18-65 years) with paraplegia (T2 or below) who sustained their spinal cord injury more than one-year ago. Participants will need to attend the laboratory at the University of Bath on two occasions (baseline and follow-up testing) separated by eight weeks. Following the first visit, participants will be randomised to a exercise group or control group. For those in the exercise group, participants will be provided with an arm crank ergometer for use in their home, and be asked to perform four exercise sessions per week (30 min each) for six weeks. For those in the control group, participants will be asked to continue their normal lifestyle.', 'detailedDescription': 'The aim of this research is to determine the effect of HIIT (vs. a control group) on biomarkers of cardiometabolic health in persons with chronic paraplegia.\n\nBaseline and follow-up assessments:\n\nBefore each visits, participants will be asked to refrain from any strenuous physical activity (2 days prior), consume no caffeine (including tea or coffee) or alcohol (1 day prior), and have fasted for at least 10 hours overnight before arriving to the University of Bath laboratories.\n\nThere will be measurements of basic anthropometrics (height, weight, waist and hip circumference), body composition (via a DEXA scan), resting metabolic rate, sub-maximal and maximal exercise capacity, and blood responses following the consumption of a sugary drink.\n\nPhysical activity and diet monitoring:\n\nParticipants will be asked to monitor their normal diet (weighed food diary) and physical activity patterns (chest-worn strap) over a 1-week period following the first visit, and in the final week of the 6-week intervention/control period.\n\nExercise intervention:\n\nThe 6-week exercise programme or control will start two weeks after the first lab visit. Participants in the exercise group will be asked to wear a heart-rate monitor for all exercise sessions, and upload their data to a smartphone for remote-monitoring by the research team.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals with a chronic (\\>12 months post-injury) SCI below T2\n* Individuals who spend \\>75% of their waking day in a wheelchair\n* Weight stable (weight not changed by \\>3% over the last 3 months)\n\nExclusion Criteria:\n\n* Individuals who an acute (\\<12 months post-injury) SCI\n* Individuals who spend \\<75% of their waking day in a wheelchair\n* Individuals on type-2 diabetes medication\n* Individuals self-reporting active medical issues (pressure sores, urinary tract infections, cardiac disorders, musculoskeletal complaints of the upper extremities, or cardiovascular contraindications to exercise testing)\n* Plans to change lifestyle during the study period'}, 'identificationModule': {'nctId': 'NCT04397250', 'briefTitle': 'High-intensity Interval Training for Cardiometabolic Health in Persons With Spinal Cord Injury', 'organization': {'class': 'OTHER', 'fullName': 'University of Bath'}, 'officialTitle': 'The Effect of High-intensity Interval Training on Biomarkers of Cardiometabolic Health in Persons With Chronic Paraplegia: A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '20/SW/0051'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High-intensity interval training', 'description': 'Participants will be asked to perform four 30 minutes bouts of high-intensity interval exercise per week.', 'interventionNames': ['Behavioral: High-intensity interval training']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants will be asked to continue their habitual lifestyle'}], 'interventions': [{'name': 'High-intensity interval training', 'type': 'BEHAVIORAL', 'description': 'Arm-cranking exercise', 'armGroupLabels': ['High-intensity interval training']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BA2 7AY', 'city': 'Bath', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Matthew Farrow', 'role': 'CONTACT', 'email': 'm.t.farrow@bath.ac.uk'}], 'facility': 'University of Bath', 'geoPoint': {'lat': 51.3751, 'lon': -2.36172}}], 'centralContacts': [{'name': 'James Bilzon', 'role': 'CONTACT', 'email': 'j.bilzon@bath.ac.uk', 'phone': '01225 383174'}], 'overallOfficials': [{'name': 'James Bizon', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bath'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bath', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'James Bilzon', 'investigatorAffiliation': 'University of Bath'}}}}