Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-30 @ 12:30 AM
Study NCT ID:
NCT07438002
Status:
RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Effects of High-intensity Physical Exercise in Subjects With Dialyzed Chronic Kidney Disease and in Conservative Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'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': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'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': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-20', 'studyFirstSubmitDate': '2026-02-13', 'studyFirstSubmitQcDate': '2026-02-20', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'effect of physical activity on mitochondrial activity', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Investigate the effect of physical activity on mitochondrial activity by analyzing the expression of mitochondrial biomarkers, MOTS-c (mg)'}, {'measure': 'Effect of physical activity on mitochondrial activity', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Investigate the effect of physical activity on mitochondrial activity by analyzing the expression of mitochondrial biomarkers, humanin (mg)'}], 'primaryOutcomes': [{'measure': 'Gait speed (6MWT)', 'timeFrame': 'through study completion, an average of 1 year', 'description': '• Assess the effect of exercise on physical performance and quality of life on pa-tients with chronic kidney disease from stage 1 to end stage renal disease on maintenance haemodialysis or on conservative treatment'}, {'measure': 'Physical performance (SPPB)', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'Cardiopulmonary capacity (CPET)', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'Lower limbs strength (1-RM)', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'Maximum isometric strength of the upper limb (hand grip)', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'Daily physical activity amount (IPAQ)', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'Quality of life (SF36)', 'timeFrame': 'through study completion, an average of 1 year'}], 'secondaryOutcomes': [{'measure': 'Nutritional status (24HR, FFQ)', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'Body composition (DEXA, BIVA)', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'Psychological and psychosocial conditions (BDI, MMSE)', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'Hemodynamic and vascular functions (SV, CO, HR, FBF, FMD, sPLM)', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'Muscular oxygen extraction (NIRS)', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'Neuromuscular functions (MCV, RFD)', 'timeFrame': 'through study completion, an average of 1 year'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nephrology', 'exercise', 'physical activity'], 'conditions': ['Chronic Kidney Disease']}, 'descriptionModule': {'briefSummary': 'This study aims to analyze the effects of physical activity in patients with chronic kidney disease undergoing dialysis or conservative treatment. Patients will be randomized into two groups: combined exercise (high-intensity aerobic resistance + strength training) and control group'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signature of the informed consent\n* Patients with CKD stage 1 to 5 under conservative treatment\n* Patients undergoing chronic hemodialysis for at least 3 months\n* Age ≥ 18\n\nExclusion Criteria:\n\n* Severe cardiovascular disease (NYHA class IV or hypertension class III)\n* TIA or myocardial ischemia within the last three months\n* Anatomical limitations\n* Health conditions detected during the stress test (CPET)'}, 'identificationModule': {'nctId': 'NCT07438002', 'acronym': 'TONE', 'briefTitle': 'Analysis of Effects of High-intensity Physical Exercise in Subjects With Dialyzed Chronic Kidney Disease and in Conservative Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Casa di Cura Dott. Pederzoli'}, 'officialTitle': 'Effect of Exercise in Patients With Chronic Kidney Disease: TONE Trial', 'orgStudyIdInfo': {'id': '573CET'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'combined exercise', 'description': 'participants will undergo a combined endurance and resistance exercise training', 'interventionNames': ['Other: Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'participants performs outcome measures sessions only, including blood sample collection.', 'interventionNames': ['Other: control']}], 'interventions': [{'name': 'Exercise', 'type': 'OTHER', 'description': 'All participants will be involved in the exercise training three times per week for 24 weeks: endurance exercise training, resistant exercise training', 'armGroupLabels': ['combined exercise']}, {'name': 'control', 'type': 'OTHER', 'description': 'outcome measures', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37019', 'city': 'Peschiera del Garda', 'state': 'Verona', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Yuri Battaglia, MD', 'role': 'CONTACT', 'email': 'urc@ospedalepederzoli.it', 'phone': '+39 0456444193'}], 'facility': 'Ospedale P. Pederzoli Casa di Cura Privata S.p.A.', 'geoPoint': {'lat': 45.43912, 'lon': 10.68614}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Casa di Cura Dott. Pederzoli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}