Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-26 @ 3:43 PM
Study NCT ID:
NCT07059559
Status:
COMPLETED
Last Update Posted:
2025-07-11
First Post:
2025-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rhythmic Walking Program and Renal Function and Oxidative Stress
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcome assessors were blinded to the intervention administered to each patient.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study is a randomized controlled trial. Patients who consent to participate and pass the screening process will be randomly assigned to groups based on the order of their participation (random by sequence). Patients who join in odd-numbered order, such as 1st, 3rd, 5th, etc., will receive standard care as provided by the hospital (control group). Patients who join in even-numbered order, such as 2nd, 4th, 6th, etc., will receive a walking program.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-01', 'studyFirstSubmitDate': '2025-07-01', 'studyFirstSubmitQcDate': '2025-07-01', 'lastUpdatePostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Creatinine level', 'timeFrame': 'Day 0 and day 91', 'description': 'Blood creatinine level was measured in mg/dL unit'}, {'measure': 'Malondialdehyde level', 'timeFrame': 'Day 0 and day 91', 'description': 'Blood malondialdehyde level was measured in micromolar unit'}, {'measure': 'Superoxide dismutase activity level', 'timeFrame': 'Day 0 and day 91', 'description': 'Blood superoxide dismutase activity level was measured in percent unit'}, {'measure': 'Estimated glomerular filtration rate level', 'timeFrame': 'Day 0 and day 91', 'description': 'Estimated glomerular filtration rate level was measured in ml/min/1.73 m2 unit'}, {'measure': 'Estimated creatinine clearance level', 'timeFrame': 'Day 0 and day 91', 'description': 'Estimated creatinine clearance level was measured in ml/min unit'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Renal Function']}, 'descriptionModule': {'briefSummary': 'This study designed a over-knee automatic step counter device. Then, we evaluated its efficacy on renal function and oxidative stress in patients with chronic kidney disease.', 'detailedDescription': 'This study is a randomized controlled trial. Patients who consent to participate and pass the screening process will be randomly assigned to groups based on the order of their participation (random by sequence). Patients who join in odd-numbered order, such as 1st, 3rd, 5th, etc., will receive standard care as provided by the hospital (control group). Patients who join in even-numbered order, such as 2nd, 4th, 6th, etc., will receive a walking program. This involves continuous walking exercise for 30 minutes, once a day, three days a week, over a period of three months. During the walking sessions, patients will walk at a pace of 60 steps per minute, or one step per second.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female\n* Aged between 18 and 59 years\n* Diagnosed by a physician with chronic kidney disease stage 2-4, with a glomerular filtration rate (GFR) between 15-89 milliliters per minute, persisting for at least 3 months\n\nExclusion Criteria:\n\n* No musculoskeletal disorders that hinder walking, such as osteoarthritis\n* Not engaging in regular exercise (less than 3 times per week or less than 150 minutes per week)\n* Not regularly taking medications or supplements containing antioxidants'}, 'identificationModule': {'nctId': 'NCT07059559', 'briefTitle': 'Rhythmic Walking Program and Renal Function and Oxidative Stress', 'organization': {'class': 'OTHER', 'fullName': 'Burapha University'}, 'officialTitle': 'Efficacy of Rhythmic Walking Program on Renal Function and Oxidative Stress in Subjects With Chronic Kidney Disease', 'orgStudyIdInfo': {'id': 'BRO 2024-074'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Patients who join in odd-numbered order, such as 1st, 3rd, 5th, etc., will receive standard care as provided by the hospital (control group).'}, {'type': 'EXPERIMENTAL', 'label': 'Rhythmic walking group', 'description': 'Patients who join in even-numbered order, such as 2nd, 4th, 6th, etc., will receive a walking program. This involves continuous walking exercise for 30 minutes, once a day, three days a week, over a period of three months. During the walking sessions, patients will walk at a pace of 60 steps per minute, or one step per second.', 'interventionNames': ['Other: Rhythmic walking']}], 'interventions': [{'name': 'Rhythmic walking', 'type': 'OTHER', 'description': 'Patients who consent to participate and pass the screening process were randomly assigned to groups based on the order of their participation (random by sequence): control group or rhythmic walking group.', 'armGroupLabels': ['Rhythmic walking group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31110', 'city': 'Chamni', 'state': 'Changwat Buri Ram', 'country': 'Thailand', 'facility': 'Rehabilitation Medicine Department, Chamni Hospital', 'geoPoint': {'lat': 14.78629, 'lon': 102.82277}}], 'overallOfficials': [{'name': 'Piyapong Prasertsri, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Allied Health Sciences, Burapha University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to make individual participant data (IPD) available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Burapha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor Dr.', 'investigatorFullName': 'Piyapong Prasertsri', 'investigatorAffiliation': 'Burapha University'}}}}