Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-25 @ 5:33 PM
Study NCT ID:
NCT05889104
Status:
COMPLETED
Last Update Posted:
2023-09-29
First Post:
2023-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Progressive Loading Protocol on Bone Mineral Density
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-08-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-27', 'studyFirstSubmitDate': '2023-05-11', 'studyFirstSubmitQcDate': '2023-06-01', 'lastUpdatePostDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measuring the result of change by Dual energy x ray absorptiometry (DXA) During the Intervention', 'timeFrame': 'At the start of the intervention, then the measurement is done again after six weeks..', 'description': 'to measure bone mineral density (BMD) at the spine and hip region. and hip regio'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Quality of life', 'Bone Mineral'], 'conditions': ['Osteoporosis']}, 'descriptionModule': {'briefSummary': "The aims of this study are to examine the effects of Progressive Loading Exercises Protocol on Bone Mineral Density in osteoporotic patient's well-being and quality of life before a fracture occurs in order to create remedies. In addition, the available data from health research and clinical studies on osteoporosis will be evaluated for their impact on patient well-being and quality of life, providing an up-to-date and comprehensive overview of evidence-based treatments.", 'detailedDescription': 'Progressive Loading Protocol (PLP): The subjects in the Progressive Loading Group will undergo 4-7 days of moderate to high impact loading activities per week for the duration of 6 weeks. The PLP is adapted and modified based on Exercise and Sports Science Australia (ESSA) position statement on exercise prescription for the prevention and management of Osteoporosis. The participants in the progressive loading group will perform vertical and multidirectional jumping, bounding, hopping, skipping rope, drop jumps and bench stepping. The weight bearing intensity will be progressed by increasing heights for activities such as bounding and drop jumping, adding weighted vests and changing directions. To prevent the risk of injury, the participants would be instructed to avoid the loaded spine flexion or twisting movements of the spine. Frail individuals should be supervised and exercised within reach of a railing or other stable support.\n\nIntensity: Moderate-to-high weight bearing impact loads (\\>2 times body weight) that are progressive, novel, and multidirectional, within the limits of pain, increasing as tolerated.\n\nFrequency: 4-7 days per week\n\nSets/Repetitions: Aim to work up to 50 repetitions over time (5 sets of 10 repetitions with 1-2 min rest between sets)\n\nThe subjects in the Control Group will undergo twelve weeks of low impact Aerobics Training along with a health awareness program..'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject with history of diabetes, hypertension\n\nExclusion Criteria:\n\n* Subject with history of kidney diseases, cardiopulmonary diseases, thrombosis, hyperprolactinemia, spondylolisthesis, back/leg deformities or surgeries, osteoarthritis, pacemakers, implants of the lower extremity and spine, tumors, migraines, or having any other diseases that affect bone metabolism or neuromuscular performance.'}, 'identificationModule': {'nctId': 'NCT05889104', 'briefTitle': 'Effect of Progressive Loading Protocol on Bone Mineral Density', 'organization': {'class': 'OTHER', 'fullName': 'Imam Abdulrahman Bin Faisal University'}, 'officialTitle': 'The Effect of Progressive Loading Protocol on Bone Mineral Density and Quality of Life in Osteoporotic Patients.', 'orgStudyIdInfo': {'id': 'PLP on Bone Mineral in OR Pt.'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The Progressive Loading Group (PLG)', 'description': 'using Progressive Loading protocol.', 'interventionNames': ['Other: Progressive Loading Protocol (PLP):']}, {'type': 'OTHER', 'label': 'TheControl Group (CG)', 'description': 'using a randomization program', 'interventionNames': ['Other: Randomization Program']}], 'interventions': [{'name': 'Randomization Program', 'type': 'OTHER', 'description': 'The subjects in the Control Group will undergo twelve weeks of low impact Aerobics Training along with a health awareness program', 'armGroupLabels': ['TheControl Group (CG)']}, {'name': 'Progressive Loading Protocol (PLP):', 'type': 'OTHER', 'description': 'he subjects in the Progressive Loading Group will undergo 4-7 days of moderate to high impact loading activities per week.', 'armGroupLabels': ['The Progressive Loading Group (PLG)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62456', 'city': 'Khamis Mushait', 'state': "'Asir Region", 'country': 'Saudi Arabia', 'facility': 'Armed Forces Hospital', 'geoPoint': {'lat': 18.3, 'lon': 42.73333}}], 'overallOfficials': [{'name': 'SAEED MUFLEH ALNASSER, MSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Armed Forces Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imam Abdulrahman Bin Faisal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Physiotherapist', 'investigatorFullName': 'Saeed Mufleh', 'investigatorAffiliation': 'Imam Abdulrahman Bin Faisal University'}}}}