Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-01-02 @ 12:56 AM
Study NCT ID:
NCT05345535
Status:
UNKNOWN
Last Update Posted:
2022-04-26
First Post:
2022-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Effects of Trampoline Exercises
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016138', 'term': 'Walking'}], 'ancestors': [{'id': 'D008124', 'term': 'Locomotion'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two randomized controlled group'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-04-18', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-25', 'studyFirstSubmitDate': '2022-04-19', 'studyFirstSubmitQcDate': '2022-04-25', 'lastUpdatePostDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in Y balance test score', 'timeFrame': 'Immediately after the intervention', 'description': 'Balance score is going to be assess by Y balance test to determine change from baseline.'}, {'measure': 'Change from baseline in ankle position sense degree', 'timeFrame': 'Immediately after the intervention', 'description': 'Ankle position sense degree is going to be assess by electroconiometer to determine change from baseline.'}, {'measure': 'Change from baseline in vertical jump distance', 'timeFrame': 'Immediately after the intervention', 'description': 'Vertical jump distance (centimeter) is going to be assess by vertical jump test by a tape measure.'}, {'measure': 'Change from baseline in myotonometric characteristics', 'timeFrame': 'Immediately after the intervention', 'description': 'Myotonometric characteristic is going to be assess by MyotonPRO device.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in cognitive status', 'timeFrame': 'Immediately after the intervention', 'description': 'Cognitive status is going to be assess by Stroop Test. Correct and false answers will be record. More correct answer shows higher cognitive status.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Balance', 'Joint position sense', 'Myoton', 'Foot and ankle'], 'conditions': ['Exercise', 'Aerobic Exercise']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate the acute effects of trampoline exercises on balance, proprioception, vertical jump and cognitive functions. As a result of the study, it is thought that trampoline exercises will affect balance, proprioception, vertical jump, cognitive functions and myotonometric properties of the muscle more positively than walking.', 'detailedDescription': '30 healthy, volunteer women who meet the inclusion criteria will be included in the study. Participants will be divided into two group randomly. The women in the study group will be evaluated before the first trampoline exercise sessions and the acute effect will be evaluated by re-evaluating at the end of the 45-minute (min) session. The control group women will be evaluated and after 45 minutes of walking, they will be evaluated again for the acute effect over the relevant parameters. The evaluations to be made to the participants are given below;\n\n* Demographic Information Form (Age, height (cm), weight (kg), occupation, education level, previous and present diseases, smoking, etc.)\n* Balance Evaluation - Y Balance Test\n* Ankle joint position sense - Electrogoniometer\n* Cognitive assessment - Stroop test\n* Vertical jump test - tape measure\n* Myotonometric properties of gastrocnemius, tibialis anterior and peroneal muscles- Myoton device'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Females who agreed to participate in the study voluntarily,\n* Female individuals between the ages of 18-65 years old\n* Females who have mini mental test score more than 25\n\nExclusion Criteria:\n\n* Those with a Body Mass Index (BMI) greater than 30 kg/m²,\n* Pregnant women,\n* Those with following problems; neural findings, malignancy, inflammation, arthritis, metabolic bone disease, column vertebralis or lower extremity surgery, cardiovascular system diseases, severe osteoporosis, communication and hearing disorders, chronic diseases such as diabetes, hypertension,\n* Those who illiterate,\n* Individuals who do sports for more than 150 minutes a week,\n* Individuals with a professional sports background, Individuals who do sports for more than 150 minutes a week\n* Individuals with a professional sports background'}, 'identificationModule': {'nctId': 'NCT05345535', 'briefTitle': 'Acute Effects of Trampoline Exercises', 'organization': {'class': 'OTHER', 'fullName': 'Hasan Kalyoncu University'}, 'officialTitle': 'Investigation of the Acute Effects of Trampoline Exercises on Balance, Proprioception, Vertical Jump and Cognitive Functions', 'orgStudyIdInfo': {'id': '2022/033'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'Participants of study group will perform 45 minutes of trampoline exercises. Evaluations are going to be done immediately before and after trampoline session.', 'interventionNames': ['Other: Trampoline exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Control group', 'description': 'Participants of control group will perform 45 minutes of walking. Evaluations are going to be done immediately before and after walking session.', 'interventionNames': ['Other: Walking']}], 'interventions': [{'name': 'Trampoline exercise', 'type': 'OTHER', 'description': '45 minutes of exercises that includes upper and lower extremity movements a trampoline with music', 'armGroupLabels': ['Study group']}, {'name': 'Walking', 'type': 'OTHER', 'description': '45 minutes of moderate tempo walking', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Gaziantep', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Elif Dinler, Master degree', 'role': 'CONTACT', 'email': 'elif.dokunlu@hku.edu.tr', 'phone': '+905314920222'}], 'facility': 'Hasan Kalyoncu University', 'geoPoint': {'lat': 37.05944, 'lon': 37.3825}}], 'centralContacts': [{'name': 'Elif Dinler, Master degree', 'role': 'CONTACT', 'email': 'elif.dokunlu@hku.edu.tr', 'phone': '+905314920222'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hasan Kalyoncu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'Elif Dinler', 'investigatorAffiliation': 'Hasan Kalyoncu University'}}}}