Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 11:25 PM
Study NCT ID:
NCT07289893
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-12-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigation of the Effects of Kettlebell Training
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020069', 'term': 'Shoulder Pain'}, {'id': 'D000070636', 'term': 'Rotator Cuff Injuries'}], 'ancestors': [{'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012421', 'term': 'Rupture'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2025-12-04', 'studyFirstSubmitQcDate': '2025-12-04', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Shoulder Pain and Disability Index (SPADI)', 'timeFrame': '0th and 8th Week', 'description': 'It is a self-report questionnaire that measures pain and disability in the shoulder. It consists of 13 items in 2 subscales: pain (5 items) and disability (8 items). Items for both subscales are measured with visual analog scales ranging from 0 (no pain or difficulty) to 10 (worst pain imaginable or difficult enough to require assistance).'}, {'measure': 'Seated Single-Arm Shot-Put Test', 'timeFrame': '0th and 8th Week', 'description': "Participants are placed in a position that does not restrict arm movement on the test side. In this position, they are instructed to hold a 3 kg ball in their hands at shoulder level with pain. Thus, from this initial positioning the participant pushes the ball as far as possible without noticing any compensation with the body. The evaluator administers the test independently and requests 3 applications at the participant's maximum capacity, with verbal stimulation and 1 minute rest between repetitions, and the average of these 3 applications is calculated."}, {'measure': 'Upper Extremity Y Balance Test', 'timeFrame': '0th and 8th Week', 'description': 'For testing; The mechanism is established by combining 1.5 meter (m) lines in the medial, inferolateral and superolateral directions at appropriate angles. For the test, participants are asked to come into a push-up position and reach in all three directions with their free hands. Maximum reach distance will be recorded in centimeters (cm). In order to normalize the reach distances according to the limb length, the maximum values in each direction are summed, divided by 3 times the limb length and multiplied by 100.'}, {'measure': 'Closed Kinetic Chain Upper Extremity Stability Test', 'timeFrame': '0th and 8th Week', 'description': 'Individuals will be positioned in a push-up position with their bodies aligned in a straight line when viewed from the side, with a distance of 90 cm between their hands. Athletes will be asked to touch the dominant hand to the dorsum of the other hand within 15 seconds, and the total number of repetitions is recorded. The tests are repeated three times with a 45-second rest between tests and the average of the results is recorded.'}, {'measure': 'Evaluation of Shoulder Isometric Muscle Strength', 'timeFrame': '0th and 8th Week', 'description': 'Values resulting from isometric contraction will be recorded in kg. Muscle strength measurements will be evaluated bilaterally, in three repetitions, for 5 seconds. The average value of the triplicate results obtained will be recorded.'}, {'measure': 'Evaluation of Hand Grip Strength', 'timeFrame': '0th and 8th Week', 'description': 'Measurements were made while the individuals were standing, with the elbow and wrist in full extension. Measurements are repeated three times at 5-second intervals on the dominant and non-dominant hands (first right, then left and right again, etc.) and recorded in kilograms, and then their average is taken.'}], 'secondaryOutcomes': [{'measure': 'Global Rating of Change (GROC)', 'timeFrame': '0th and 8th Week', 'description': 'This scale is a frequently used scale for the evaluation of clinical research in the musculoskeletal field. It is used to determine the improvement or deterioration of patients over a specified period of time. On the numerical scale, one represents "my pain has decreased a lot in a good way," while seven means "my pain has increased a lot in a bad way," and people report changes in pain compared to baseline.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Kettlebell Exercises'], 'conditions': ['Shoulder Pain', 'Rotator Cuff Injuries']}, 'descriptionModule': {'briefSummary': 'Kettlebell exercises are seen as one of the approaches that can be used conservatively in individuals with shoulder pain. However, it is still unknown what results it has on its therapeutic effects. These findings highlight the need for higher quality studies evaluating the effects of kettlebell use and exercises for shoulder pain. Therefore, the purpose of this study was to investigate the effects of 8 weeks of kettlebell training on shoulder pain, function, and performance.\n\nThe hypotheses of our study are as follows:\n\n* H1: In individuals with Rotator Cuff-Related Shoulder Pain, the improvement in shoulder-related pain perception is greater with Kettlebell training compared to the standard rehabilitation program.\n* H2: In individuals with Rotator Cuff Related Shoulder Pain, shoulder function improvement is greater with Kettlebell training compared to the standard rehabilitation program.\n* H3: In individuals with Rotator Cuff-Related Shoulder Pain, shoulder performance improvement is greater with Kettlebell training than with the standard rehabilitation program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals who are willing to participate and have been doing licensed/unlicensed amateur or professional sports for at least 3 years,\n* Individuals with Tegner Activity Scale ≥ 5,\n* A history of shoulder pain of at least 6 weeks,\n* At least 3 points measured using the 0 to 10 point Numerical Pain Scale (NPS),\n* Shoulder pain that worsens with resisted shoulder flexion, abduction or external rotation,\n* Rotator cuff tendinopathies,\n* Tears smaller than 1 cm,\n* Secondary shoulder instability without major trauma (due to rotator cuff muscle weakness, etc.)\n\nExclusion Criteria:\n\n* History of fracture and/or surgery in the shoulder area,\n* Adhesive capsulitis,\n* Those with passive joint range of motion deficit,\n* Individuals with a positive Apprehension Test and/or Sulcus Sign test and multidirectional shoulder instability,\n* Numbness or tingling in the upper extremity with cervical compression test or upper extremity compression test,\n* Systemic or neurological disease,\n* Corticosteroid injection within 3 months before the intervention,\n* Physical therapy in the 6 months before the intervention,\n* Those with a history of dislocation and subluxation,\n* Those who are pregnant,\n* Those who did not participate in the study for 2 consecutive sessions'}, 'identificationModule': {'nctId': 'NCT07289893', 'briefTitle': 'Investigation of the Effects of Kettlebell Training', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Investigation of the Effects of Kettlebell Training on Pain, Function and Performance in Rotator Cuff-Related Shoulder Pain; Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': '30.01.2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise Group', 'description': 'Kettlebell Exercise Group', 'interventionNames': ['Other: Kettlebell Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Standard Rehabilitation Group', 'interventionNames': ['Other: Standard Exercise']}], 'interventions': [{'name': 'Kettlebell Exercise', 'type': 'OTHER', 'description': '8-week Kettlebell Exercises compare with 8-week Standard Rehabilitation Program', 'armGroupLabels': ['Exercise Group']}, {'name': 'Standard Exercise', 'type': 'OTHER', 'description': '8-week Standard Rehabilitation Program compare with 8-week Kettlebell Exercises', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'status': 'NOT_YET_RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Çağdaş Işıklar', 'role': 'CONTACT', 'email': 'cagdasisiklar@gmail.com', 'phone': '+905439638565'}, {'name': 'Elif Turgut', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hacettepe University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Prof Sener', 'role': 'CONTACT', 'email': 'goksel.sener@fbu.edu.tr', 'phone': '+902169101907'}], 'facility': 'Fenerbahce University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof', 'investigatorFullName': 'Elif Turgut', 'investigatorAffiliation': 'Hacettepe University'}}}}