Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:07 AM
Study NCT ID:
NCT02621918
Status:
COMPLETED
Last Update Posted:
2016-07-27
First Post:
2015-10-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Exercise in End-stage Renal Disease Patients Undergoing Hemodialysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-25', 'studyFirstSubmitDate': '2015-10-21', 'studyFirstSubmitQcDate': '2015-12-01', 'lastUpdatePostDateStruct': {'date': '2016-07-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body composition by Dual-energy x-ray absorptiometry (DEXA)', 'timeFrame': 'before and after 12 and 24 weeks of study', 'description': 'Dual-energy x-ray absorptiometry (DEXA) was used to measure lean body mass (LBM), fat mass (FM) and Bone Mineral Contend (BMC) in grams using a total body scan, following the equipment description - HOLOGIC Discovery Wi (Hologic inc, Waltham, MA, USA). Body composition variables included in this study were total mass, body FM, LBM and legs LBM, and BMC. Body composition was assessed after a hemodialysis day; time after previous hemodialysis did not exceed eight hours.'}], 'secondaryOutcomes': [{'measure': 'Quality of life assessed by the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36)', 'timeFrame': 'before and after 12 and 24 weeks of study', 'description': 'Quality of life assessment was analyzed using the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36). The SF-36 is composed of eleven issues of 36 items that assess eight dimensions events occurred in the last four weeks. For the presentation of the survey results, the final score of each domain was transformed into a scale from 0 (worse) to 100 (better). Total score, mental e physical dimensions were analyzed separated.'}, {'measure': 'Functional capacity', 'timeFrame': 'before and after 12 and 24 weeks of study', 'description': 'The 6 minutes walking test measured the walking capacity (distance in meters) during 6 minutes. The sit-to-stand test assessed the lower limbs strength resistance by times that the subject stand and sit (chair) during 30 seconds. And flexibility was assessed by sit and reach test.'}, {'measure': 'Pulmonary capacity', 'timeFrame': 'before and after 12 and 24 weeks of study. Additionally this variable was assessed over the three time points before and after one hemodialysis session.', 'description': 'For the assessment of maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) an analog manovacuometer (Gerar ®, 0±300 cmH2O) was used. Patients underwent three valid maneuvers and the most negative and most positive in MIP and MEP, respectively, were considered. Ventilometer (Ferraris Mark8 Wright Respirometer®) detected the low vital capacity (LVC). Reduced forced expiratory volume in one second (FEV1), reduced forced vital capacity (FVC), normal FEV1/FVC ratio, and forced expiratory flow between 25% and 75% of vital capacity (FEF25-27) were evaluated with the spirometer brand IQTeQ. Spirometric variables were analyzed in reference percentage values in order to eliminate the effects of age, height, and gender. The assay was performed in order to obtain three acceptable curves with at least two reproducible curves five minutes interval for each exam for a total of up to eight trials.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['End Stage Renal Failure on Dialysis']}, 'referencesModule': {'references': [{'pmid': '35018639', 'type': 'DERIVED', 'citation': 'Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.'}]}, 'descriptionModule': {'briefSummary': 'We aimed to investigate the effect of a progressive resistance training and aerobic training protocol on functional capacity, body composition and quality of life.', 'detailedDescription': 'Subjects were randomized into group A and B: group A (n=30) exercised for the first 6 months while group B (n=31) performed a placebo exercise initially (3 months) and cross-over to aerobic exercised for 3 months more.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* older than 18 years\n* more than three months of hemodialysis vintage\n* under the permission of their nephrologist\n* agreement to be randomly assigned and undergo study protocols\n\nExclusion Criteria:\n\n* Patients in wheelchair, presenting disability, or those who had amputation and malformation of the lower limbs, causing impaired walking\n* presenting representative blindness'}, 'identificationModule': {'nctId': 'NCT02621918', 'acronym': 'EESRDS', 'briefTitle': 'The Effects of Exercise in End-stage Renal Disease Patients Undergoing Hemodialysis', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Estadual Paulista Júlio de Mesquita Filho'}, 'officialTitle': 'The Effects of an Intradialytic Progressive Resistance and Aerobic Training in End-stage Renal Disease Patients Undergoing Hemodialysis', 'orgStudyIdInfo': {'id': 'CAAE-02564112.2.0000.5423'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Progressive Resistance Training (PRT)', 'description': 'For the progressive resistance training we use 11 exercises. The exercises for upper limbs were held in the waiting room before the hemodialysis session. Resistance exercise was carried out in two sets of 15-20 repetitions, the intensity were determined by the method of maximal repetitions, where series were run until exhaustion to momentary exercises (15-20 repetitions) with specific load. The load adjustments or volume were managed when necessary, but necessarily for every 4th week of training. The effort perception should be situated between 12 and 16 on the Borg scale (Borg and Noble, 1974), as proposed by The Life Options Rehabilitation Advisory Council: Exercise for the Patient Dialysis (1995).', 'interventionNames': ['Other: Progressive resistance training']}, {'type': 'EXPERIMENTAL', 'label': 'Aerobic Exercise (AER)', 'description': 'Aerobic exercise was conducted with a mini ergometer cycling (Mini Bike E5 Acte Sports) attached to the patient chair. Patients exercised 50-60 minutes of continuous workout with increased load. The workload was adjusted when necessary, according to the perceived effort made by the patient. The scale of perceived exertion, Borg scale (Borg and Noble , 1974), was used in accordance with the proposed By The Life Options Rehabilitation Advisory Council: Exercise for the Patient Dialysis (1995), which defines the values of perceived exertion between 12 and 16.', 'interventionNames': ['Other: Aerobic training']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'NEPLA', 'description': 'The control group performed active mobilization of members, circumduction of cervical, scapular girdle and extremities, breathing exercises with no loads, set on three to five repetitions only and no stretch exercises. The exercises were performed during the hemodialysis session, three times per week and did not exceed 5 minutes.', 'interventionNames': ['Other: Placebo training']}], 'interventions': [{'name': 'Progressive resistance training', 'type': 'OTHER', 'armGroupLabels': ['Progressive Resistance Training (PRT)']}, {'name': 'Aerobic training', 'type': 'OTHER', 'armGroupLabels': ['Aerobic Exercise (AER)']}, {'name': 'Placebo training', 'type': 'OTHER', 'armGroupLabels': ['NEPLA']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Estadual Paulista Júlio de Mesquita Filho', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD Student', 'investigatorFullName': 'Clara S C Rosa', 'investigatorAffiliation': 'Universidade Estadual Paulista Júlio de Mesquita Filho'}}}}