Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-02-21 @ 4:08 AM
Study NCT ID:
NCT02041156
Status:
UNKNOWN
Last Update Posted:
2016-09-23
First Post:
2014-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Different Exercise Training Programs in CKD 4-5
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], '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'}]}, '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']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-09-22', 'studyFirstSubmitDate': '2014-01-07', 'studyFirstSubmitQcDate': '2014-01-17', 'lastUpdatePostDateStruct': {'date': '2016-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Compliance to exercise training protocol', 'timeFrame': '4, 8 and 12 month'}], 'primaryOutcomes': [{'measure': 'Physical function', 'timeFrame': '4, 8 and 12 months', 'description': '6 minutes walking test, 30 seconds sit to stand, stair climbing, handgrip strength, Isometric quadriceps strength, functional reach, standing heel rise, toes lift, picking-up test, Berg balance scale'}], 'secondaryOutcomes': [{'measure': 'Cardiovascular morbidity', 'timeFrame': 'after 12 months'}, {'measure': 'Body composition', 'timeFrame': 'after 12 months'}, {'measure': 'Quality of Life', 'timeFrame': '4,8 and 12 months'}, {'measure': 'Inflammatory activity', 'timeFrame': '4, 8 and 12 months'}, {'measure': 'Bone density', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Kidney Disease']}, 'referencesModule': {'references': [{'pmid': '41083942', 'type': 'DERIVED', 'citation': 'Petrauskiene V, Hellberg M, Svensson P, Clyne N. Markers of bone turnover after 12 months of exercise in patients with chronic kidney disease 3-5: a post-hoc analysis of RENEXC - a randomized controlled trial. BMC Nephrol. 2025 Oct 13;26(1):561. doi: 10.1186/s12882-025-04501-9.'}, {'pmid': '39849350', 'type': 'DERIVED', 'citation': 'Denguir S, Hellberg M, Almquist M, Clyne N. Survival in patients with CKD 3-5 after 12 months of exercise training - a post-hoc analysis of the RENEXC trial. BMC Nephrol. 2025 Jan 23;26(1):36. doi: 10.1186/s12882-024-03915-1.'}, {'pmid': '32571327', 'type': 'DERIVED', 'citation': 'Zhou Y, Hellberg M, Hellmark T, Hoglund P, Clyne N. Twelve months of exercise training did not halt abdominal aortic calcification in patients with CKD - a sub-study of RENEXC-a randomized controlled trial. BMC Nephrol. 2020 Jun 22;21(1):233. doi: 10.1186/s12882-020-01881-y.'}, {'pmid': '31848626', 'type': 'DERIVED', 'citation': 'Zhou Y, Hellberg M, Hellmark T, Hoglund P, Clyne N. Muscle mass and plasma myostatin after exercise training: a substudy of Renal Exercise (RENEXC)-a randomized controlled trial. Nephrol Dial Transplant. 2021 Jan 1;36(1):95-103. doi: 10.1093/ndt/gfz210.'}]}, 'descriptionModule': {'briefSummary': 'The investigators\' purpose is to study which exercise training modality: aerobic physical activity in conjunction with either resistance training or balance training, is most beneficial in patients with chronic kidney disease (CKD 4-5: GFR \\< 30 ml/min/1.73mUP\\[2\\]). Furthermore, our purpose is to evaluate the long-term effects of exercise training on functional status, cardiovascular morbidity, blood pressure control, heart rate variability, cardiac function, inflammation, body composition, nutritional status, progression of uraemia and health related quality of life. This interventional study is prospective, randomized and controlled comprising 150 prevalent and incident patients from our outpatient clinic. Patients are invited to participate in the study consecutively, irrespective of basic functional status. At start patients are randomised either to resistance or balance training and the programme is adapted and individualised to each patient\'s actual physical status and ability. The exercise prescription is to exercise for 30 minutes/day, 5 days/week, keeping the intensity constant at a level of "somewhat strenuous" to "strenuous" on the Borg scale rate of perceived exertion. The total observation period is 12 months with checks every four months. Although exercise training is a recommended therapy in CKD, there is a lack of medical and scientific evidence on optimal prescription. We hope that this study will provide evidence-based knowledge on exercise prescription and its effects on various risk factors in CKD patients. Finally, if patients achieve a higher degree of physical functional capacity they should be able to maintain an autonomous lifestyle, resulting in considerable reductions in societal costs for care and transportation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CKD 4 and 5\n* over 18 years of age\n* no neurological or orthopedic impairments\n* stable cardiac status\n\nExclusion Criteria:\n\n* not on renal replacement therapy\n* no severe electrolyte disturbances'}, 'identificationModule': {'nctId': 'NCT02041156', 'acronym': 'RENEXC', 'briefTitle': 'Effects of Different Exercise Training Programs in CKD 4-5', 'organization': {'class': 'OTHER', 'fullName': 'Region Skane'}, 'officialTitle': 'Long-term Effects of Basic Aerobic Training Combined With Either Resistance - or Balance Training in CKD Patients - a Comparative Study', 'orgStudyIdInfo': {'id': '2011:369'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'aerobic with resistance training', 'description': 'Regular aerobic activity combined with 3 sessions/week of resistance training totalling 150 minutes per week of physical activity', 'interventionNames': ['Other: aerobic and resistance training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'aerobic with balance training', 'description': 'Regular aerobic activity combined with 3 sessions/week of balance training totalling 150 minutes per week of physical activity', 'interventionNames': ['Other: aerobic combined with balance training']}], 'interventions': [{'name': 'aerobic and resistance training', 'type': 'OTHER', 'armGroupLabels': ['aerobic with resistance training']}, {'name': 'aerobic combined with balance training', 'type': 'OTHER', 'armGroupLabels': ['aerobic with balance training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '221 85', 'city': 'Lund', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Matthias Hellberg, MD', 'role': 'CONTACT', 'email': 'Matthias.Hellberg@skane.se', 'phone': '+4646175886'}], 'facility': 'Skåne University Hospital', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}], 'centralContacts': [{'name': 'Naomi Clyne, MD,PhD', 'role': 'CONTACT', 'email': 'Naomi.Clyne@med.lu.se', 'phone': '+4646 171682'}, {'name': 'Matthias Hellberg, MD', 'role': 'CONTACT', 'email': 'Matthias.Hellberg@skane.se', 'phone': '+4646175886'}], 'overallOfficials': [{'name': 'Naomi Clyne, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lund University'}, {'name': 'Matthias Hellberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lund University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Skane', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}