Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT07133256
Status:
COMPLETED
Last Update Posted:
2025-08-21
First Post:
2025-08-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Aerobic Versus Resistance Training on Bone Metabolism in Stage 3-4 Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D002114', 'term': 'Calcinosis'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D012080', 'term': 'Chronic Kidney Disease-Mineral and Bone Disorder'}, {'id': 'C536059', 'term': 'Osteopetrosis, mild autosomal recessive form'}], 'ancestors': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D002128', 'term': 'Calcium Metabolism Disorders'}, {'id': 'D012279', 'term': 'Rickets'}, {'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D006962', 'term': 'Hyperparathyroidism, Secondary'}, {'id': 'D006961', 'term': 'Hyperparathyroidism'}, {'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'None (Open Label)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Interventional (Clinical Trial)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2025-08-06', 'studyFirstSubmitQcDate': '2025-08-13', 'lastUpdatePostDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Serum Osteoprotegerin (OPG) and RANKL Concentrations', 'timeFrame': 'Baseline to 6 months post-intervention', 'description': 'To determine biochemical changes in bone metabolism markers. Both OPG (pg/mL) and RANKL (ng/mL) are measured using validated ELISA kits.'}, {'measure': 'Change in Bone Mineral Density (BMD)', 'timeFrame': 'Baseline to 6 months post-intervention', 'description': 'To assess densitometric changes in skeletal structure due to exercise. BMD is measured in g/cm² using ISCD-certified DEXA equipment.'}, {'measure': 'Change in OPG/RANKL Ratio', 'timeFrame': 'To assess the regulatory balance of bone remodeling. A higher OPG/RANKL ratio reflects reduced osteoclastic activity and improved bone metabolic status.', 'description': 'Baseline to 6 months post-intervention'}], 'secondaryOutcomes': [{'measure': 'Change in eGFR (estimated Glomerular Filtration Rate)', 'timeFrame': 'Baseline to 6 months', 'description': 'To explore the potential renal benefits of structured exercise in CKD patients. Measured in mL/min/1.73 m².'}, {'measure': 'Change in Serum Albumin and Hemoglobin Levels', 'timeFrame': 'Baseline to 6 months', 'description': 'These indicators provide information about overall nutritional and hematologic status. Albumin (g/dL) and Hemoglobin (g/dL) are assessed via standard lab procedures.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic kidney disease', 'RANKL, OPG/RANKL Ratio', 'Osteoprotegerin', 'Aerobic Exercise', 'Resistance Exercise', 'Bone mineral density'], 'conditions': ['Osteopenia', 'Bone Metabolism Disorders', 'Chronic Kidney Disease (Stage 3-4)', 'Mineral and Bone Disorder (CKD-MBD)']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial investigates the comparative effects of aerobic versus resistance training on bone mineral density (BMD) and bone metabolism markers in patients with stage 3 or 4 chronic kidney disease (CKD). The primary aim is to evaluate the impact of two distinct exercise modalities on serum osteoprotegerin (OPG), receptor activator of nuclear factor kappa-B ligand (RANKL), and the OPG/RANKL ratio, as well as densitometric changes at key skeletal sites.', 'detailedDescription': 'Chronic kidney disease-mineral and bone disorder (CKD-MBD) is a common complication in non-dialysis CKD patients, driven by disrupted calcium-phosphate metabolism, secondary hyperparathyroidism, and altered bone remodeling pathways, such as the OPG-RANKL axis. Exercise is an emerging non-pharmacological strategy to mitigate skeletal deterioration in CKD, yet the differential effects of aerobic and resistance training on bone health remain poorly understood in this population.\n\nThis study recruited 60 CKD patients (stage 3-4, aged 30-50 years) and randomly allocated them into two groups (n=30 each): a resistance training group and an aerobic exercise group. Both groups underwent supervised exercise 3 times per week for six months. Bone mineral density was assessed using dual-energy X-ray absorptiometry (DEXA) at the lumbar spine (L2-L4), femoral neck, and distal radius. Serum concentrations of OPG and RANKL were measured via ELISA at baseline and post-intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'genderBased': True, 'genderDescription': '30 to 50', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 30 to 50 years\n* Diagnosed with stage 3 or 4 chronic kidney disease (non-dialysis dependent)\n* BMI between 20 and 24 kg/m²\n* Not currently taking medications that affect bone density (e.g., corticosteroids, bisphosphonates)\n* Non-smokers and abstinent from alcohol\n* Not receiving hormone replacement therapy\n* Willing and able to participate in supervised exercise sessions for 6 months\n\nExclusion Criteria:\n\n* Diagnosis of type 1 diabetes mellitus\n* Uncontrolled hypertension\n* History of cardiovascular, musculoskeletal, endocrine, or metabolic bone disease\n* Pregnant or planning pregnancy during the study period\n* Participation in a structured exercise program within the last 3 months\n* Contraindications to exercise as determined by medical evaluation\n* Use of investigational drugs or enrollment in another clinical trial during the study period'}, 'identificationModule': {'nctId': 'NCT07133256', 'acronym': 'CKD-BONE-EX', 'briefTitle': 'Effects of Aerobic Versus Resistance Training on Bone Metabolism in Stage 3-4 Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Sinai University'}, 'officialTitle': 'Effects of Aerobic Versus Resistance Training on Bone Metabolism in Stage 3-4 Chronic Kidney Disease: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SU.REC.2025(45H)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Resistance Exercise Group (Group A)', 'description': 'Participants in this arm engaged in supervised resistance training three times per week for six months. Each session included:\n\n5-minute warm-up with dynamic stretching and range-of-motion exercises\n\n30-minute resistance training using weight machines targeting major muscle groups (upper limbs, lower limbs, and trunk)\n\nIntensity: 60% to 80% of one-repetition maximum (1-RM), adjusted progressively\n\n10-minute cool-down with static stretching Sessions were monitored by trained physiotherapists.', 'interventionNames': ['Behavioral: Resistance Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aerobic Exercise Group (Group B)', 'description': 'Participants in this arm performed supervised aerobic exercise (treadmill walking) three times per week for six months. Each session included:\n\n5-minute warm-up\n\n30-minute treadmill walking at 60%-80% of age-predicted maximum heart rate (HRmax = 220 - age)\n\n10-minute cool-down Exercise sessions were supervised by trained exercise professionals and tailored to maintain target heart rate zones.', 'interventionNames': ['Behavioral: Aerobic Training']}], 'interventions': [{'name': 'Resistance Exercise', 'type': 'BEHAVIORAL', 'description': 'Structured machine-based resistance exercise protocol performed under supervision, targeting osteogenic loading to improve bone mineral density and alter bone metabolism markers in CKD stage 3-4 patients.', 'armGroupLabels': ['Resistance Exercise Group (Group A)']}, {'name': 'Aerobic Training', 'type': 'BEHAVIORAL', 'description': 'Participants in this arm performed supervised aerobic exercise (treadmill walking) three times per week for six months. Each session included:\n\n5-minute warm-up\n\n30-minute treadmill walking at 60%-80% of age-predicted maximum heart rate (HRmax = 220 - age)\n\n10-minute cool-down Exercise sessions were supervised by trained exercise professionals and tailored to maintain target heart rate zones.', 'armGroupLabels': ['Aerobic Exercise Group (Group B)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44511', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Manshyet El-Bakry Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Dr. Shehab Abd E-Kader, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '1Department of Physical Therapy, Faculty of Medical Rehabilitation Sciences, King Abdulaziz University, Jeddah, Saudi Arabia.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sinai University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer', 'investigatorFullName': 'Amany Gomaa Atiaa', 'investigatorAffiliation': 'Sinai University'}}}}