Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-02-21 @ 11:17 PM
Study NCT ID:
NCT02832466
Status:
COMPLETED
Last Update Posted:
2017-04-05
First Post:
2016-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quantifying the Deterioration of Physical Function in Renal Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-04', 'studyFirstSubmitDate': '2016-07-08', 'studyFirstSubmitQcDate': '2016-07-11', 'lastUpdatePostDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline Short Physical Performance Battery at 6 months', 'timeFrame': 'At the beginning of the study and after 6 months', 'description': 'Assess lower extremity, which includes objective performance-based measure of balance (side-by-side, semi-tanden and tandem), endurance (4m gait speed) and strength (five chair stands). Each component was scored from 0 to 4 and when summed yielded Short Physical Performance Battery scores between 0 (poor) and 12 (best).'}, {'measure': 'Change from Baseline One Leg Standing Test at 6 months', 'timeFrame': 'At the beginning of the study and after 6 months', 'description': 'Consist in maintain one leg stance for as long as possible. The test was considered normal if the one leg standing time reached 45 seconds.'}, {'measure': 'Change from Baseline Timed Up and Go at 6 months', 'timeFrame': 'At the beginning of the study and after 6 months', 'description': 'To stand up from a standard arms chair, walk 3 meters, turn back the cone walk back and sit down to the chair. The time in seconds is record.'}, {'measure': 'Change from Baseline Sit to Stand to Sit 10 and 60 at 6 months', 'timeFrame': 'At the beginning of the study and after 6 months', 'description': 'For the Sit To Stand 10 participant has to stand up and sit down 10 times and the time needed is record; while for the Sit to stand to sit 60 the participant consist in measures how many repetition the participant can to stand up and sit down during 60 seconds'}, {'measure': 'Change from Baseline On leg heel rise at 6 months', 'timeFrame': 'At the beginning of the study and after 6 months', 'description': 'It measures the strength in the triceps surae in the one leg standing position and has to rise the heel. It measures how many repetitions the participants is can do'}, {'measure': 'Change from Baseline Handgrip strength at 6 months', 'timeFrame': 'At the beginning of the study and after 6 months', 'description': 'To measure the amount of strength developed by each hand in kg'}, {'measure': 'Change from Baseline Six Minutes Walking Time at 6 months', 'timeFrame': 'At the beginning of the study and after 6 months', 'description': 'To walk the longest distance possible in 6 minutes by walking continuously the 20 or 30 metres indicated on the floor. It measures the distance in meters'}]}, 'conditionsModule': {'conditions': ['End Stage Renal Disease']}, 'descriptionModule': {'briefSummary': 'Patients undergoing haemodialysis present a decrease in physical function, but little is known about the rate at which function decreases.\n\nThe purpose of this study is quantifying the nature and degree of functional deterioration experienced by stage 5 chronic kidney disease patients during a six month period of maintenance haemodialysis therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'People with Chronic Kidney Diseases undergoing hemodialysis treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* people under hemodialysis treatment at least 3 months\n* be medicable stable\n* complete all the physical tests\n\nExclusion Criteria:\n\n* heart stroke in the previous 6 weeks of the study\n* inferior limb amputation without artificial aids\n* cerebral vascular disease (ictus, ischemic)\n* disability to complete functional tests'}, 'identificationModule': {'nctId': 'NCT02832466', 'briefTitle': 'Quantifying the Deterioration of Physical Function in Renal Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cardenal Herrera University'}, 'officialTitle': 'Quantifying the Deterioration of Physical Function Along 6 Months in Patients in End Stage Renal Disease', 'orgStudyIdInfo': {'id': 'Cardenal Herrera Univeristy'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Functional Test', 'type': 'OTHER', 'description': 'Observation of physical function in hemodialysis patients during a period of 6 months'}]}, 'contactsLocationsModule': {'locations': [{'zip': '46113', 'city': 'Moncada', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Universidad CEU Cardenal Herrera', 'geoPoint': {'lat': 39.54555, 'lon': -0.39551}}], 'overallOfficials': [{'name': 'Eva Segura OrtÃ', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lecturer in the Cardenal Herrera University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cardenal Herrera University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Eva Segura OrtÃ', 'investigatorAffiliation': 'Cardenal Herrera University'}}}}