Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-02-22 @ 2:19 PM
Study NCT ID:
NCT03905551
Status:
COMPLETED
Last Update Posted:
2021-10-06
First Post:
2019-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Cold Dialysis in Combination With Intradialytic Exercise in Aspects Related to Quality of Life and Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'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': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The current study is a randomized clinical trial lasting for 7 months. Hemodialysis patients, which fulfilled the inclusion criteria, randomly divided into two groups: a) typical dialysis with dialysate temperature at 37°C (TD+EX) in combination with aerobic intradialytic exercise training, b) cold dialysis with dialysate temperature at 35°C (CD) in combination with aerobic intradialytic exercise training (CD+ET).\n\nPatients enrolled by a research assistant assigned into the study while the order that the patients assigned to the first scenario was randomly using a computer random number generator.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-28', 'studyFirstSubmitDate': '2019-03-29', 'studyFirstSubmitQcDate': '2019-04-04', 'lastUpdatePostDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Body Heat Storage', 'timeFrame': 'Changes from baseline at 7 months', 'description': 'Body Heat storage will be assessed during the 4 hours of dialysis under the two main conditions. Body Heat Storage is calculated in Watt'}, {'measure': 'Change in Insulin Resistance', 'timeFrame': 'Changes from baseline at 7 months', 'description': 'Insulin resistances will be assessed by an Oral Glucose Tolerance Test using the OGIS index'}, {'measure': 'Change in Muscle Size', 'timeFrame': 'Changes from baseline at 7 months', 'description': 'Muscle size will be assessed using Ultrasonography'}], 'secondaryOutcomes': [{'measure': 'Change in Quality of life score', 'timeFrame': 'Changes from baseline at 7 months', 'description': 'Quality of life will be assessed using the Sort Form 36 questionnaire. The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status and is consisted of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.\n\nThe eight sections are:\n\n* vitality\n* physical functioning\n* bodily pain\n* general health perceptions\n* physical role functioning\n* emotional role functioning\n* social role functioning\n* mental health'}, {'measure': 'Change in Functional Capacity', 'timeFrame': 'Changes from baseline at 7 months', 'description': 'Functional capacity will be assessed by the 6 min walking test'}, {'measure': 'Change in Daily Physical activity', 'timeFrame': 'Changes from baseline at 7 months', 'description': 'Daily physical activity will be assessed by a 7 day recall pedometer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cold dialysis', 'intradialytic exercise', 'insulin resistance', 'thermoregulation', 'muscle architecture', 'quality of life', 'fitness', 'fatigue', 'physical activity'], 'conditions': ['End Stage Renal Failure on Dialysis']}, 'referencesModule': {'references': [{'pmid': '4184202', 'type': 'BACKGROUND', 'citation': 'Parnas I, Spira M, Werman R, Bergmann F. Micro-electrode studies of the giant fibres of the American cockroach. Electroencephalogr Clin Neurophysiol. 1969 Aug;27(2):221. No abstract available.'}, {'pmid': '33267815', 'type': 'BACKGROUND', 'citation': 'Krase AA, Flouris AD, Karatzaferi C, Giannaki CD, Stefanidis I, Sakkas GK. Separate and combined effects of cold dialysis and intradialytic exercise on the thermoregulatory responses of hemodialysis patients: a randomized-cross-over study. BMC Nephrol. 2020 Dec 2;21(1):524. doi: 10.1186/s12882-020-02167-z.'}, {'pmid': '38261536', 'type': 'DERIVED', 'citation': 'Krase AA, Giannaki CD, Flouris AD, Liakos D, Stefanidis I, Karatzaferi C, Sakkas GK. The Acute, Combined, and Separate Effects of Cold Hemodialysis and Intradialytic Exercise in Insulin Sensitivity and Glucose Disposal. ASAIO J. 2024 May 1;70(5):436-441. doi: 10.1097/MAT.0000000000002117. Epub 2024 Jan 23.'}, {'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.'}, {'pmid': '34184202', 'type': 'DERIVED', 'citation': 'Krase AA, Terzis G, Giannaki CD, Stasinaki AN, Wilkinson TJ, Smith AC, Zorz C, Karatzaferi C, Stefanidis I, Sakkas GK. Seven months of aerobic intradialytic exercise training can prevent muscle loss in haemodialysis patients: an ultrasonography study. Int Urol Nephrol. 2022 Feb;54(2):447-456. doi: 10.1007/s11255-021-02931-6. Epub 2021 Jun 28.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/28540201', 'label': "Cold dialysis and its impact on renal patients' health: An evidence-based mini review."}, {'url': 'https://www.ncbi.nlm.nih.gov/pubmed/28682991', 'label': 'The Effect of Cold Dialysis in Motor and Sensory Symptoms of RLS/WED Occurring During Hemodialysis: A Double-Blind Study.'}]}, 'descriptionModule': {'briefSummary': "Despite the tremendous advances in dialysis technology, hemodialysis (HD) is a significant challenge for dialysis patients and quality of their lives\\[2\\]. Research has shown for years that dialysate fluid temperature and especially the typical dialysis (TD) temperature at (37°C) are complicated by hemodynamic instability which leading to an increased risk of heat-induced hypotension causing patient discomfort and increased mortality.\n\nCold dialysis (CD) is defined as the reduction of dialysis fluid temperature to 35-36°C, approximately 1°C below the typical dialysate temperature which ranges between 37-38°C. A number of studies have reported beneficial effects of CD on maintaining hemodynamic stability, minimizes hypotension and exerts a protective effect over major organs including the heart and brain. In addition, current evidence showed the protective effect of CD in cardiac performance during the dialysis session. As the investigators know until today cardiovascular mortality is an important issue for nephrologists that care for ESRD patients, however, many other benefits have been observed on patients' overall health and quality of life levels by used of CD.\n\nThe above-mentioned benefits of CD in the hemodynamic stability and the general quality of life of the patients are highlighted even further due to the ever-increasing adoption of intradialytic exercise programs. It has been well established that intradialytic exercise leads to benefits of physiological, functional, and psychological deterioration, which commonly accrues as a consequence of biological aging, catabolic illness, and a sedentary lifestyle, factors that may all contribute to the progressive decline of vitality and quality of life commonly observed in ESRD patients.\n\nHowever, despite a strong rationale for the implementation of intradialytic exercise programs and the aforementioned benefits of CD, the separate and combined effects of these protocols in aspects related to quality of life and health in ESRD patients have not been investigated to date.\n\nThe aim of the current clinical study was to assess the effect of exercise rehabilitation regimes in combination with changes in dialysate temperature in aspects related to quality of life and health in end-stage renal disease patients receiving hemodialysis.", 'detailedDescription': 'The primary aim of the clinical study was to investigate the combined effect of cold dialysis and aerobic exercise in aspects related to health. More specific:\n\n1. To investigate the thermoregulatory responses of hemodialysis patients under four different hemodialysis protocols.\n2. To assess the changes in muscular architecture and functional capacity in dialysis patients after 7 months of intradialytic exercise training.\n3. To assess the impact on insulin sensitivity and glucose disposal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinically stable ESRD patients receiving regular hemodialysis treatment for at least 3 months,\n* adequate dialysis delivery Kt/V \\>1.1\n* good compliance of dialysis treatment\n* serum albumin \\>2.5 g/dL\n* hemoglobin ≥11g/dL.\n\nExclusion Criteria:\n\n* Patients with a reason to be in a catabolic state,\n* hyperthyroidism,\n* active vasculitis,\n* malignancies,\n* pregnancy\n* HIV,\n* opportunistic infections,\n* musculoskeletal contraindication to exercise,\n* requirement for systemic anticoagulation,\n* participant or participated in an investigational drug or medical device study within 30 days,\n* active inflammations, that required intravenous antibiotics within 3 months prior to enrollment,\n* diabetics receiving insulin therapy,\n* New York Heart Association grade IV heart failure,\n* mental incapacity to consent.'}, 'identificationModule': {'nctId': 'NCT03905551', 'acronym': 'REACD', 'briefTitle': 'Impact of Cold Dialysis in Combination With Intradialytic Exercise in Aspects Related to Quality of Life and Health', 'organization': {'class': 'OTHER', 'fullName': 'University of Thessaly'}, 'officialTitle': 'The Effect of Exercise Rehabilitation Regimes in Combination With Changes in Dialysis Procedures in Aspects Related to Quality of Life and Health in End Stage Renal Disease Patients', 'orgStudyIdInfo': {'id': '921-5/11/2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Standard Dialysis', 'description': 'Patients participated in a 7 months exercise trials receiving standard dialysis (at 37oC)', 'interventionNames': ['Procedure: Typical Dialysis', 'Procedure: Exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Cold Dialysis', 'description': 'Patients participated in a 7 months exercise trials receiving cold dialysis (at 35oC)', 'interventionNames': ['Procedure: Cold Dialysis', 'Procedure: Exercise']}], 'interventions': [{'name': 'Cold Dialysis', 'type': 'PROCEDURE', 'description': 'Dialysate temperature reduced to 35oC for a period of 7 months.', 'armGroupLabels': ['Cold Dialysis']}, {'name': 'Typical Dialysis', 'type': 'PROCEDURE', 'description': 'Dialysate temperature is set at 37oC for a period of 7 months', 'armGroupLabels': ['Standard Dialysis']}, {'name': 'Exercise', 'type': 'PROCEDURE', 'description': 'Aerobic Intradialytic exercise training', 'armGroupLabels': ['Cold Dialysis', 'Standard Dialysis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41110', 'city': 'Larissa', 'state': 'Thessaly', 'country': 'Greece', 'facility': 'University Hospital of Larissa, Nephrology Clinic', 'geoPoint': {'lat': 39.62847, 'lon': 22.42112}}, {'city': 'Larissa', 'state': 'Thessaly', 'country': 'Greece', 'facility': 'Patsidis General Clinic', 'geoPoint': {'lat': 39.62847, 'lon': 22.42112}}, {'zip': '42100', 'city': 'Trikala', 'state': 'Thessaly', 'country': 'Greece', 'facility': 'General Hospital of Trikala', 'geoPoint': {'lat': 39.55493, 'lon': 21.76837}}], 'overallOfficials': [{'name': 'Giorgos K Sakkas, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Thessaly'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Thessaly', 'class': 'OTHER'}, 'collaborators': [{'name': 'National and Kapodistrian University of Athens', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor in Clinical Exercise Physiology', 'investigatorFullName': 'Giorgos K. Sakkas', 'investigatorAffiliation': 'University of Thessaly'}}}}