Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2026-01-01 @ 9:10 PM
Study NCT ID:
NCT03980795
Status:
COMPLETED
Last Update Posted:
2019-06-11
First Post:
2019-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise in Peritoneal Dialysis Patients (PDEX)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}, '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'], 'maskingDescription': 'Blinded Statistical Analysis'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-09', 'studyFirstSubmitDate': '2019-05-29', 'studyFirstSubmitQcDate': '2019-06-07', 'lastUpdatePostDateStruct': {'date': '2019-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of Study - number of patients safely completing the study', 'timeFrame': '1 month', 'description': 'The number of patients safely completing the study relative to the sampling frame'}, {'measure': 'Adherence to exercise - total number of self-reported exercise sessions attempted divided by the total number of exercise sessions prescribed', 'timeFrame': '3 months', 'description': 'the total number of self-reported exercise sessions attempted divided by the total number of exercise sessions prescribed'}], 'secondaryOutcomes': [{'measure': '30 second sit to stand test', 'timeFrame': '3 months', 'description': 'Requires a participant to stand from a chair as many times as possible in 30 seconds'}, {'measure': 'Pinch Strength Test', 'timeFrame': '3 months', 'description': "consists of three pinch tests: the tip pinch, lateral pinch and palmar pinch. All were performed following the American Society of Hand Therapists' recommendations"}, {'measure': 'Timed Up and Go', 'timeFrame': '3 months', 'description': 'the time in seconds it takes an adult to rise from sitting in a standard chair, walk 8 feet, turn, walk back to the chair and sit down using regular footwear'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['exercise', 'physical function', 'patient reported outcomes'], 'conditions': ['Peritoneal Dialysis', 'Kidney Failure, Chronic']}, 'referencesModule': {'references': [{'pmid': '32734246', 'type': 'DERIVED', 'citation': 'Bennett PN, Hussein WF, Matthews K, West M, Smith E, Reiterman M, Alagadan G, Shragge B, Patel J, Schiller BM. An Exercise Program for Peritoneal Dialysis Patients in the United States: A Feasibility Study. Kidney Med. 2020 Mar 17;2(3):267-275. doi: 10.1016/j.xkme.2020.01.005. eCollection 2020 May-Jun.'}]}, 'descriptionModule': {'briefSummary': 'Patients with end-stage kidney disease (ESKD) receiving peritoneal dialysis (PD) are physically inactive, resulting in poor physical function and reduced quality of life. The aim of this pilot trial was to test the study feasibility of a combined resistance and cardiovascular exercise program (recruitment and retention rates) and report adherence and adverse events. The intervention (I) group received monthly exercise physiologist consultations, exercise prescription (resistance and aerobic exercise program using exercise bands) and weekly phone calls over 12 weeks. Control (C) group received normal care. Feasibility outcomes were exercise adherence rates and adverse events. Secondary measures included physical function measures and patient-reported outcome measures (PROMs)', 'detailedDescription': 'Patients with end-stage kidney disease (ESKD) receiving peritoneal dialysis (PD) are physically inactive, resulting in poor physical function and reduced quality of life. Combined resistance and cardiovascular exercise programs have been shown to be successful in hemodialysis patients but studies are limited in PD patients. The primary objectives of this pilot trial was to test the study feasibility of a combined resistance and cardiovascular exercise program (recruitment and retention rates) and report adherence and adverse events. Secondary objectives were to calculate the sample size for detecting differences in the 30 second sit to stand test (STS30) and measure the effect on physical function and patient reported outcome measures (PROMs).\n\nMethods: The 3-month parallel two-arm pilot trial took place in California, USA. All participants were peritoneal dialysis patients in a single center who met inclusion criteria were invited into a randomized controlled trial. Recruitment was through face to face invitation following eligibility requirements. The intervention (I) group received monthly exercise physiologist consultations, exercise prescription (resistance and aerobic exercise program using exercise bands) and weekly phone calls over 12 weeks. Control (C) group received normal care. Feasibility outcomes were exercise adherence rates and adverse events. Secondary physical function measures were change in I compared to the C group in STS30, pinch strength test (PST) and the 8 foot timed up and go test (8TUG). PROMs were measured using the London Evaluation of Illness (LEVIL) instrument. Data collection was not blinded but statistical analysis was blinded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* end-stage kidney disease\n* receiving peritoneal dialysis for greater than 6 weeks\n* approved by the center Medical Director\n\nExclusion Criteria:\n\n* unable to understand English\n* previous major amputations\n* unable to ambulate independently\n* known to be pregnant'}, 'identificationModule': {'nctId': 'NCT03980795', 'acronym': 'PDEX', 'briefTitle': 'Exercise in Peritoneal Dialysis Patients (PDEX)', 'organization': {'class': 'OTHER', 'fullName': 'Satellite Healthcare'}, 'officialTitle': 'Resistance and Cardiovascular Exercise for Peritoneal Dialysis Patients: a Randomized Pilot Study for a Parallel Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SH107'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'The intervention (I) group received monthly exercise physiologist consultations, exercise prescription (resistance and aerobic exercise program using exercise bands) and weekly phone calls over 12 weeks.', 'interventionNames': ['Other: Exercise Program']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Usual care'}], 'interventions': [{'name': 'Exercise Program', 'type': 'OTHER', 'description': "Participants met with an exercise physiologist at their monthly center appointment over a 3-month period (4 meetings). The consultations took place either together or separate from or with the dietitian's consultation (depending on appointment logistics). In addition the Exercise Physiologists telephone called each intervention participant on a weekly basis.", 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95821', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Satellite Wellbound Sacramento', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'Brigitte Schiller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Satellite Healthcare'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'timeFrame': 'De-identified data will be available. Results will disseminated through peer reviewed publication.', 'ipdSharing': 'YES', 'description': 'All feasibility data will be published'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Satellite Healthcare', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}