Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2025-12-29 @ 4:51 PM
Study NCT ID:
NCT01179906
Status:
COMPLETED
Last Update Posted:
2010-08-11
First Post:
2010-08-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lifestyle Modifications and the Progression of Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D004035', 'term': 'Diet Therapy'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-01', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-10', 'studyFirstSubmitDate': '2010-08-10', 'studyFirstSubmitQcDate': '2010-08-10', 'lastUpdatePostDateStruct': {'date': '2010-08-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glomerular filtration rate (GFR)', 'timeFrame': '48 weeks', 'description': 'GFR was estimated using the MDRD equation, creatinine clearance, urea clearance'}], 'secondaryOutcomes': [{'measure': '24 hour urine protein output', 'timeFrame': '48 weeks', 'description': 'urine protein output is measured before and after 48 weeks of the training program'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CKD'], 'conditions': ['Patients With Stage 2-4 Chronic Kidney Disease']}, 'descriptionModule': {'briefSummary': 'Aerobic training has been shown to favorably alter several of the known risk factors for coronary artery disease including hypertension, dyslipidemia, obesity, and diabetes (1). It seems logical that if these risk factors were aggressively controlled in patients with chronic kidney disease (CKD) by implementing lifestyle changes (e.g., diet and exercise training) to support the pharmacologic interventions that are necessary for the control of the disease, then the rate of progression of the disease may be altered. However, to date, there is no clear research evidence to support this hypothesis. Therefore the aims of the proposed study are:\n\n1. To test the hypothesis that lifestyle interventions (i.e., dietary modification and regular, long-term aerobic exercise training) will favorably alter the natural progression of CKD in a sample of patients compared to a control group who will receive the current standard care.\n2. To explore possible mechanisms that could contribute to the observed changes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stages 2-4 CKD\n\nExclusion Criteria:\n\n* CAD\n* MI'}, 'identificationModule': {'nctId': 'NCT01179906', 'briefTitle': 'Lifestyle Modifications and the Progression of Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Springfield College'}, 'officialTitle': 'Effect of Lifestyle Interventions on the Progression of Kidney Disease in Patients With Chronic Kidney Disease', 'orgStudyIdInfo': {'id': 'BHS research incubator study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lifestyle intervention-exercise & diet', 'description': 'Subjects trained for 48 weeks with a personal trainer', 'interventionNames': ['Behavioral: Exercise training', 'Behavioral: Diet modification']}], 'interventions': [{'name': 'Exercise training', 'type': 'BEHAVIORAL', 'description': 'Subjects exercise trained for 48 weeks with personal trainers at a college wellness center', 'armGroupLabels': ['Lifestyle intervention-exercise & diet']}, {'name': 'Diet modification', 'type': 'BEHAVIORAL', 'description': 'Exercise training using personal trainers 3 times per week. Individuals were trained at a moderate intensity', 'armGroupLabels': ['Lifestyle intervention-exercise & diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01109', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Springfield College', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}], 'overallOfficials': [{'name': 'Sam A Headley, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Springfield College'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Springfield College', 'class': 'OTHER'}, 'collaborators': [{'name': 'Western New England Renal & Transplant Associates', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Samuel Headley', 'oldOrganization': 'Springfield College'}}}}