Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-03-02 @ 11:04 PM
Study NCT ID:
NCT07260318
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-03
First Post:
2025-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Effects of Cricket Fast Bowling on Bone Turnover and Signaling Markers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 14}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2025-11-14', 'studyFirstSubmitQcDate': '2025-11-20', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum C-terminal telopeptide of type I collagen (CTX-I) concentration', 'timeFrame': 'Blood samples are collected at baseline, immediately after the bowling or the corresponding rest period, and 2 hours after the second blood sample collection.', 'description': 'Serum CTX-I concentration is measured using electrochemiluminescence immunoassay (ECLIA) and reported in nanograms per milliliter (ng/mL).'}], 'secondaryOutcomes': [{'measure': 'Serum N-terminal propeptide of type I collagen (PINP) concentration', 'timeFrame': 'Blood samples are collected at baseline, immediately after the bowling or the corresponding rest period, and 2 hours after the second blood sample collection.', 'description': 'Serum PINP concentration is measured using electrochemiluminescence immunoassay (ECLIA) and reported in nanograms per milliliter (ng/mL).'}, {'measure': 'Serum parathyroid hormone (PTH) concentration', 'timeFrame': 'Blood samples are collected at baseline, immediately after the bowling or the corresponding rest period, and 2 hours after the second blood sample collection.', 'description': 'Serum PTH concentration is measured using electrochemiluminescence immunoassay (ECLIA) and reported in picograms per milliliter (pg/mL).'}, {'measure': 'Serum sclerostin concentration', 'timeFrame': 'Blood samples are collected at baseline, immediately after the bowling or the corresponding rest period, and 2 hours after the second blood sample collection.', 'description': 'Serum sclerostin concentration is measured using an enzyme-linked immunosorbent assay (ELISA) and reported in picograms per milliliter (pg/mL).'}, {'measure': 'Serum dickkopf Wnt signaling pathway inhibitor 1 (DKK1) concentration', 'timeFrame': 'Blood samples are collected at baseline, immediately after the bowling or the corresponding rest period, and 2 hours after the second blood sample collection.', 'description': 'Serum DKK1 concentration is measured using an enzyme-linked immunosorbent assay (ELISA) and reported in picograms per milliliter (pg/mL).'}, {'measure': 'Serum osteoprotegerin (OPG) concentration', 'timeFrame': 'Blood samples are collected at baseline, immediately after the bowling or the corresponding rest period, and 2 hours after the second blood sample collection.', 'description': 'Serum OPG concentration is measured using an enzyme-linked immunosorbent assay (ELISA) and reported in picograms per milliliter (pg/mL).'}, {'measure': 'Serum irisin concentration', 'timeFrame': 'Blood samples are collected at baseline, immediately after the bowling or the corresponding rest period, and 2 hours after the second blood sample collection.', 'description': 'Serum irisin concentration is measured using an enzyme-linked immunosorbent assay (ELISA) and reported in picograms per milliliter (pg/mL).'}, {'measure': 'Bowling speed', 'timeFrame': 'Bowling speed is measured during the bowling trial.', 'description': 'Bowling speed is measured using a radar gun during the 8 overs of bowling and reported in miles per hour (MPH).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cricket', 'Fast bowling', 'Bone turnover', 'Stress injuries'], 'conditions': ['Health Adults']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to investigate the acute effects of cricket fast bowling on the bone turnover and signaling markers in healthy young males.\n\nThe main question aims to answer:\n\n• Does a single bout acute fast bowling change serum C-terminal telopeptide of type I collagen (CTX-I) and other bone turnover and signaling markers levels?\n\nParticipants complete both the bowling and control trials, with a minimum washout period of one week between trials. During each trial, blood samples are collected at three time points: pre-, immediately post, and 2-hour post bowling/rest.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male\n* Aged 18 - 30\n* Cricket fast bowlers (a ball speed of \\~100kmh) playing for a university team or above, such as British Universities and Colleges Sport (BUCS) or University Centre of Cricketing Excellence (UCCE)\n* Injury free for the last 3 months\n\nExclusion Criteria:\n\n* Diagnosed with any disease or use of any medication that affects bone turnover\n* Fracture experienced within the previous year/season'}, 'identificationModule': {'nctId': 'NCT07260318', 'briefTitle': 'Acute Effects of Cricket Fast Bowling on Bone Turnover and Signaling Markers', 'organization': {'class': 'OTHER', 'fullName': 'Loughborough University'}, 'officialTitle': 'Acute Effects of Cricket Fast Bowling on Bone Turnover and Signaling Markers', 'orgStudyIdInfo': {'id': '11201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm Bowling + Control', 'description': 'Participants first perform the bowling trial, followed by the control trial, with a minimum interval of one week between the two trials.', 'interventionNames': ['Behavioral: Exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Arm Control + Bowling', 'description': 'Participants first perform the control trial, followed by the bowling trial, with a minimum interval of one week between the two trials.', 'interventionNames': ['Behavioral: Exercise']}], 'interventions': [{'name': 'Exercise', 'type': 'BEHAVIORAL', 'description': 'During the bowling trial, participants perform 8 sets of 6 deliveries (bowl at match intensity throughout), followed by 2-hour rest. Each set is interspersed by a 3-minute randomized fielding simulation. During the control trial, participants rest throughout instead of bowling.', 'armGroupLabels': ['Arm Bowling + Control', 'Arm Control + Bowling']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LE11 3TU', 'city': 'Loughborough', 'state': 'Leicestershire', 'country': 'United Kingdom', 'facility': 'Loughborough Univeristy', 'geoPoint': {'lat': 52.76667, 'lon': -1.2}}], 'overallOfficials': [{'name': 'Katherine Brooke-Wavell', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Loughborough University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loughborough University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Katherine Brooke-Wavell', 'investigatorAffiliation': 'Loughborough University'}}}}