Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2026-01-05 @ 6:34 PM
Study NCT ID:
NCT02701569
Status:
COMPLETED
Last Update Posted:
2016-10-27
First Post:
2016-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Rebound Exercise in Individuals With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-26', 'studyFirstSubmitDate': '2016-02-17', 'studyFirstSubmitQcDate': '2016-03-02', 'lastUpdatePostDateStruct': {'date': '2016-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': "Depressive symptoms as measured by the Beck's Depression Inventory", 'timeFrame': '3 months', 'description': 'Score ranges from 0 to 63 with 0 to 13 being minimal and 29 to 63 being severe'}], 'primaryOutcomes': [{'measure': 'Glycated hemoglobin', 'timeFrame': '3 months', 'description': 'Glycated hemoglobin was assessed using the mini-column ion-exchange chromatographic method and expressed in percentage'}], 'secondaryOutcomes': [{'measure': 'Fasting plasma glucose', 'timeFrame': '3 months', 'description': 'Fasting plasma glucose (in molar concentration) was measured by glucose oxidase assay using a glucose analyzer'}, {'measure': 'Fasting insulin', 'timeFrame': '3 months', 'description': 'Fasting insulin (in gravimetric unit) was determined using a commercially available ELISA human insulin kit'}, {'measure': 'High-density lipoprotein cholesterol', 'timeFrame': '3 months', 'description': 'High-density lipoprotein cholesterol (in molar concentration) was enzymatically determined using commercial kits'}, {'measure': 'Total cholesterol', 'timeFrame': '3 months', 'description': 'Total cholesterol (in molar concentration) was enzymatically determined using commercial kits'}, {'measure': 'Triglycerides', 'timeFrame': '3 months', 'description': 'Triglycerides (in molar concentration) were enzymatically determined using commercial kits'}, {'measure': 'Low-density lipoprotein cholesterol', 'timeFrame': '3 months', 'description': 'Low-density lipoprotein cholesterol (in molar concentration) was estimated using the Friedewald formula.'}, {'measure': 'Quality of life', 'timeFrame': '3 months', 'description': "The short-form 36 health questionnaire was used to assess participants' quality of life and expressed in percentage"}, {'measure': 'Body mass', 'timeFrame': '3 months', 'description': 'Body mass in kilograms was determined using a calibrated weighing scale'}, {'measure': 'Height', 'timeFrame': '3 months', 'description': 'Height in meters was determined using a stadiometer'}, {'measure': 'Heart rate', 'timeFrame': '3 months', 'description': 'Heart rate was measured in beats per minute using a calibrated electronic device'}, {'measure': 'Respiratory rate', 'timeFrame': '3 months', 'description': 'Respiratory rate (in cycles per minute) was measured by observing and counting the number of times the chest rose in one minute'}, {'measure': 'Blood pressure', 'timeFrame': '3 months', 'description': 'Blood pressure in millimeters of mercury (mmHg) was measured using a calibrated electronic device'}, {'measure': 'Maximal oxygen consumption', 'timeFrame': '3 months', 'description': 'Maximal oxygen consumption in milliliters per kilogram per minute (ml/kg/min) was obtained from exercise stress testing'}, {'measure': 'Diabetes-related emotional distress as measured by the Problem Areas in Diabetes Scale', 'timeFrame': '3 months', 'description': 'Diabetes-related emotional distress was expressed in percentage'}, {'measure': 'Well-Being as measured by the World Health Organization-Well-Being Index', 'timeFrame': '3 months', 'description': "Participants' well-being was expressed in percentage"}, {'measure': 'Treatment satisfaction as measured by the World Health Organization-Diabetes Treatment Satisfaction Questionnaire', 'timeFrame': '3 months', 'description': 'Score ranges from 0 (very dissatisfied) to 36 (very satisfied)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to investigate the effect of rebound exercise (mini trampoline jumping) on metabolic outcomes and quality of life in patients with Type 2 Diabetes.', 'detailedDescription': 'The exercise involved jumping on the mini trampoline with feet slightly apart. Participants stood on the mid portion of the trampoline bed and made repeated up-and-down bouncy movements. Each foot strike equals one step or bounce. With each landing, the mat of the trampoline underwent deformation and the springs released the energy stored in them such that the participant was made to bounce off the mat. Exercise was administered for between 10 - 15 minutes after which a 5-minute period of rest was allowed. A heart rate monitor was used to guide the intensity of the exercise in the moderate range. Each participant accumulated between 20 and 30 minutes of rebound exercise (bouncing on a mini trampoline) per session, administered three times per week for 12 weeks. All data were captured at baseline and at the end of the 12-week intervention period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 30- to 60-year-old male and female individuals;\n* A diagnosis of type 2 diabetes ≤ 5 years;\n* Attendance at the Diabetes Outpatient Clinics of Aminu Kano Teaching Hospital and Murtala Muhammad Specialist Hospital in Kano, Northwestern Nigeria;\n* Self-ambulatory;\n* An inactive lifestyle over the last year.\n\nExclusion Criteria:\n\n* A diagnosis of type 2 diabetes for more than 5 years;\n* Hypertension (systolic and diastolic blood pressure more than 140 and 90 mmHg, respectively) or treatment for hypertension;\n* Use of insulin therapy\n* Lower limb weakness and/or deformities with loss of protective sensation in the feet;\n* Back, shoulder or knee problems and/or joint instability;\n* History of coronary artery disease, retinopathy and nephropathy;\n* Myocardial infarction, cardiac or abdominal surgery within the previous 6 months;\n* History of fractures of the spine, hip, knee and/or ankle joints.'}, 'identificationModule': {'nctId': 'NCT02701569', 'briefTitle': 'Effect of Rebound Exercise in Individuals With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of KwaZulu'}, 'officialTitle': 'Effect of Rebound Therapy on Metabolic Outcomes and Quality of Life in Nigerian Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'BF389/13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rebound exercise', 'description': 'Repeated jumping on a mini trampoline was performed with feet slightly apart', 'interventionNames': ['Other: Rebound exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No exercise was administered but participants continued with routine medical care'}], 'interventions': [{'name': 'Rebound exercise', 'type': 'OTHER', 'otherNames': ['Mini trampoline rebounding'], 'description': 'Repeated jumping on a mini trampoline was administered', 'armGroupLabels': ['Rebound exercise']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Sonill S Maharaj, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'UKZN'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data would not be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of KwaZulu', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aminu Kano Teaching Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}