Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2025-12-30 @ 5:01 AM
Study NCT ID:
NCT05795504
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-08-20
First Post:
2023-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Resistive Exercise Versus HIIT on Calcium and Vitamin D
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D Deficiency'}], 'ancestors': [{'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072696', 'term': 'High-Intensity Interval Training'}, {'id': 'D002118', 'term': 'Calcium'}, {'id': 'D014807', 'term': 'Vitamin D'}], 'ancestors': [{'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D008673', 'term': 'Metals, Alkaline Earth'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-19', 'studyFirstSubmitDate': '2023-03-21', 'studyFirstSubmitQcDate': '2023-03-21', 'lastUpdatePostDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vitamin D serum level', 'timeFrame': 'three months', 'description': 'a blood sample of each participant will be taken to measure serum vitamin D level before and after the study'}, {'measure': 'serum calcium level', 'timeFrame': 'three months', 'description': 'a blood sample will be taken from each participant to measure calcium level of each participant before and after the study.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vitamin D Deficiency', 'Calcium', 'Premenopause']}, 'descriptionModule': {'briefSummary': 'A comparison between resistive exercise and high intensity interval trainig on calcium and vitamin d in premenopausal women.', 'detailedDescription': 'A total of 57% of women were vitamin D deficient with higher vitamin D deficiency found among premenopausal women (64.7%). Concentrations of 25(OH) D, defined as severely deficient (\\< 12 ng/ml), deficient (12-19 ng/ml), insufficient (20-30 ng/ml) and sufficient (\\> 30 ng/ml). Both severe vitamin D deficiency and calcium deficiency was significantly more frequent in premenopausal women compared to postmenopausal women. So, it is important to find effective therapeutic approaches to treat vitamin D deficiency among these women'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Premenopausal women having reduced calcium level (less than 500mg) intake as recorded by 24 hours' dietary recall method and vitamin D deficiency (12-19 ng/ml).\n* Their ages will range from 40 to 45 years.\n* Their BMI will range from 25-30 kg/m2.\n* Don't receive hormonal replacement therapy.\n\nExclusion Criteria:\n\n* Smoking.\n* History of chronic disease (uncontrolled hypertension, diabetes mellitus)\n* Osteoporosis.\n* severe musculoskeletal disorders\n* cardiovascular disease, thyroid dysfunction"}, 'identificationModule': {'nctId': 'NCT05795504', 'briefTitle': 'Resistive Exercise Versus HIIT on Calcium and Vitamin D', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Resistive Exercise Versus High Intensity Interval Training on Calcium and Vitamin D in Premenopausal Women: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'P.T.REC/012/004342'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'resistive exercises', 'description': 'Premenopausal women in group A will perform resistive exercise for upper and lower limbs, three times per week in addition to calcium and vitamin d supplementations.', 'interventionNames': ['Other: resistive exercise', 'Dietary Supplement: calcium and vitamin D']}, {'type': 'EXPERIMENTAL', 'label': 'high intensity interval training', 'description': 'Premenopausal women in group B will receive high intensity interval training for three times per week in addition to calcium and vitamin D supplementations', 'interventionNames': ['Other: high intensity interval training', 'Dietary Supplement: calcium and vitamin D']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional therapy', 'description': 'Premenopausal women in group C will receive calcium and vitamin D supplementations only.', 'interventionNames': ['Dietary Supplement: calcium and vitamin D']}], 'interventions': [{'name': 'resistive exercise', 'type': 'OTHER', 'description': 'They will perform combined upper and lower resistive exercises, 30 min, 3 sessions / week for 12 weeks in addition to calcium and vitamin D supplements.', 'armGroupLabels': ['resistive exercises']}, {'name': 'high intensity interval training', 'type': 'OTHER', 'description': 'They will perform HIIT for three sessions/ week for 12 weeks, 30 minutes/ session in addition to calcium and vitamin D supplements.,', 'armGroupLabels': ['high intensity interval training']}, {'name': 'calcium and vitamin D', 'type': 'DIETARY_SUPPLEMENT', 'description': 'they will receive calcium and vitamin D supplements only.', 'armGroupLabels': ['conventional therapy', 'high intensity interval training', 'resistive exercises']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'country': 'Egypt', 'facility': 'Faculty of physical therapy', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'Mai shehata', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'faculty of physical therapy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "lecturer of physical therapy for women's health", 'investigatorFullName': 'Mai Mohamed Ali Shehata', 'investigatorAffiliation': 'Cairo University'}}}}