Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-01-03 @ 8:05 PM
Study NCT ID:
NCT04750694
Status:
UNKNOWN
Last Update Posted:
2021-02-11
First Post:
2020-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Intensity Resistance Training Combined With Blood Flow Restricted Exercise in Elite Handball Players
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006984', 'term': 'Hypertrophy'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'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': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-10', 'studyFirstSubmitDate': '2020-11-17', 'studyFirstSubmitQcDate': '2021-02-10', 'lastUpdatePostDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Jump Performance', 'timeFrame': 'Baseline measurements at week 1 and post intervention at week 10.', 'description': 'Change in jump height. Change in vertical jump height (in cm, with Chronojump Linear Encoder Kit). Participants will perform a counter movement jump and jump as high as possible. The jump height will be recorded.'}, {'measure': 'Sprint performance', 'timeFrame': 'Baseline measurements at week 1 and post intervention at week 10.', 'description': 'Sprint performance. Change in sprint time (in seconds, with Witt speed gates). Participant will perform a 30-meter sprint on an indoor handball court. The time to perform a 30-meter sprint will be recorded.'}], 'primaryOutcomes': [{'measure': 'Change in Maximal Muscle Strength', 'timeFrame': 'Baseline measurements at week 1, after four weeks of exercise at week 5 and post intervention at week 10.', 'description': 'Change in 1 RM (repetition maximum) muscle strength in back squat'}], 'secondaryOutcomes': [{'measure': 'Change in Lean body mass', 'timeFrame': 'Baseline measurements at week 1 and post intervention at week 10.', 'description': 'Change in lean body mass assessed by Dual Energy X-ray Absorptiometry'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['The focus is blood flow restricted exercise'], 'conditions': ['Hypertrophy']}, 'descriptionModule': {'briefSummary': 'Purpose of the study is: to investigate the effects of 8 weeks intervention of high intensity resistance training(HIRT) combined with Blood Flow Restricted Exercise (BFRE) compared to high intensity resistance training alone.\n\nDetailed Description: 30 elite handball players will be randomized into 2 groups of 15 participants each. Participants will be evaluated in the week before and the week after an 8-weeks training intervention with 2 weekly sessions. Based on their baseline muscle strength the participants will be randomized into two groups: HIRT-BFRE or HIRT-HIRT. Participants in both groups will perform a full-body training programme of HIRT. After the Full-body programme, Back squat exercise with low intensity and Blood flow restriction will be performed to the HIRT-BFRE group and back squat exercise with high intensity without blood flow restriction will be performed by HIRT-HIRT. Evaluation protocol includes: muscle strength measurement with 1 repetition maximum of Back squat and knee extension, muscle mass with Dual-Energy X-ray absorptiometry, muscle thickness of the thigh with ultra sound measurement, vertical jump height with linear Encoder, sprint performance with 30m sprint time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>= 18 years\n* Ds\n* Minimum of 2 years of resistance training experience\n* \\>\\< Two resistance training sessions each week\n* \\>\\< three handball sessions each week\n* No injuries that prevent participants to perform test of maximal muscle strength\n* No injuries, that affects the muscle strength or the ability to train\n\nExclusion Criteria:\n\n* Elevated blood pressure (\\>140/90)\n* Anabolic steroids or prescription-only medical products with know or potential effect on muscle hypertrophy'}, 'identificationModule': {'nctId': 'NCT04750694', 'briefTitle': 'High Intensity Resistance Training Combined With Blood Flow Restricted Exercise in Elite Handball Players', 'organization': {'class': 'OTHER', 'fullName': 'Department of Public Health, Denmark'}, 'officialTitle': 'High Intensity Resistance Training Combined With Blood Flow Restricted Exercise in Elite Handball Players', 'orgStudyIdInfo': {'id': 'VEK ID 74646'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RT + BFRE', 'description': 'High intensity Resistance training combined with Blood Flow', 'interventionNames': ['Behavioral: Resistance training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'RT', 'description': 'Resistance training alone', 'interventionNames': ['Behavioral: Resistance training']}], 'interventions': [{'name': 'Resistance training', 'type': 'BEHAVIORAL', 'description': 'A full-training programme with high intensity followed by back squat exercise with blood flow restriction. Inflatable cuffs will be placed proximally on both thighs. The cuff pressure will be 50% of individual arterial occlusion pressure and will be maintained during the rest intervals. Participants will perform 30, 15, 15 and 15 repetitions of 30% of 1 Repetition Maximum. Totally 75 repetitions will be performed. 45 seconds rest interval between sets will be given.', 'armGroupLabels': ['RT', 'RT + BFRE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Simon Lønbro, PhD', 'role': 'CONTACT', 'email': 'loenbro@ph.au.dk', 'phone': '21600410'}, {'name': 'Esben Madsen, MSc student', 'role': 'CONTACT'}, {'name': 'Mikkel Garbrecht, MSc student', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Dept. of Public Health', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'centralContacts': [{'name': 'Simon Lønbro, PhD', 'role': 'CONTACT', 'email': 'loenbro@ph.au.dk', 'phone': '004521600410'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Department of Public Health, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Teaching Associate Professor, PhD', 'investigatorFullName': 'Simon Lønbro', 'investigatorAffiliation': 'Department of Public Health, Denmark'}}}}