Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 4:15 AM
Study NCT ID:
NCT07356193
Status:
COMPLETED
Last Update Posted:
2026-01-22
First Post:
2026-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serum CPK and Creatinine Changes During Plyometric Training in Collegiate Athletes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2022-12-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-21', 'studyFirstSubmitDate': '2026-01-11', 'studyFirstSubmitQcDate': '2026-01-11', 'lastUpdatePostDateStruct': {'date': '2026-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum Creatine Phosphokinase (CPK) Levels', 'timeFrame': 'Baseline; Day 2; Day 4; Week 1; Week 2; Week 4; Week 6; Week 8', 'description': 'Change in serum CPK measured using the CK-NAC optimized IFCC method.'}], 'secondaryOutcomes': [{'measure': 'Serum Creatinine Levels', 'timeFrame': 'Baseline; Day 2; Day 4; Week 1; Week 2; Week 4; Week 6; Week 8', 'description': "Measured using modified Jaffe's method."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Plyometric Training', 'Volleyball Players', 'Creatine Phosphokinase', 'Serum Creatinine'], 'conditions': ['Muscle Damage', 'Plyometric Exercises', 'Creatine Kinase', 'Exercise Physiology']}, 'descriptionModule': {'briefSummary': 'This retrospective study evaluated the effects of an eight-week lower body plyometric training program on serum creatine phosphokinase (CPK) and creatinine levels in male collegiate volleyball players. Sixty two players were divided into experimental and control groups. CPK and creatinine were measured at baseline and multiple time points during training. The study assessed whether plyometric training produced harmful biochemical changes or signs of rhabdomyolysis.', 'detailedDescription': 'This study evaluated the physiological effects and safety of an eight-week lower body plyometric training program in male collegiate volleyball players, focusing on changes in serum creatine phosphokinase (CPK) and creatinine levels. Sixty two healthy athletes were randomly assigned to either a plyometric training group or a control group. The experimental group performed progressive lower body plyometric exercises twice weekly for eight weeks, while the control group continued regular volleyball training.\n\nSerum CPK and creatinine were assessed at baseline and multiple time points throughout the intervention. CPK levels in the training group increased significantly early in the program, peaking on Day 4 and remaining elevated until Week 2, before returning to baseline by Week 8. Importantly, all values remained within normal clinical ranges, and no signs of rhabdomyolysis or overtraining were observed. Serum creatinine levels showed no significant changes, indicating preserved renal function. No biomarker changes were detected in the control group.\n\nThese findings indicate that an eight-week, progressively designed plyometric training program is safe and well tolerated in male collegiate volleyball players.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '20 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male collegiate volleyball players\n* Age: 18-20 years\n* No prior plyometric training\n\nExclusion Criteria:\n\n* History of kidney disease\n* Current musculoskeletal injury\n* neuromuscular impairments'}, 'identificationModule': {'nctId': 'NCT07356193', 'briefTitle': 'Serum CPK and Creatinine Changes During Plyometric Training in Collegiate Athletes', 'organization': {'class': 'OTHER', 'fullName': 'Batterjee Medical College'}, 'officialTitle': 'Effects of Lower Body Plyometric Training on Serum Creatine Phosphokinase and Creatinine Levels in Male Collegiate Volleyball Players', 'orgStudyIdInfo': {'id': 'BMC-CPK-Study-2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lower Body Plyometric Training', 'interventionNames': ['Behavioral: Lower Body Plyometric Training', 'Other: control group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'interventionNames': ['Other: control group']}], 'interventions': [{'name': 'Lower Body Plyometric Training', 'type': 'BEHAVIORAL', 'description': 'Training twice weekly for eight weeks, including low-, moderate-, and high-intensity plyometric exercises (squat jumps, box jumps, tuck jumps, split squat jumps, lateral hurdle jumps, zigzag jumps, single-leg tuck jumps, and depth jumps).', 'armGroupLabels': ['Lower Body Plyometric Training']}, {'name': 'control group', 'type': 'OTHER', 'description': 'Routine volleyball training only; no plyometric exercises.', 'armGroupLabels': ['Control Group', 'Lower Body Plyometric Training']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jeddah', 'country': 'Saudi Arabia', 'facility': 'Batterjee Medical College', 'geoPoint': {'lat': 21.49012, 'lon': 39.18624}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared because participant consent did not include permission for data sharing and the dataset contains sensitive physiological information.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Batterjee Medical College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mohamed A. Abdel Ghafar', 'investigatorAffiliation': 'Batterjee Medical College'}}}}