Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT03885102
Status:
COMPLETED
Last Update Posted:
2022-12-02
First Post:
2019-03-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dialysis Training Therapy: The DiaTT Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Random assignment in 1:1 ratio into either intervention group (12 months intradialytic exercise intervention; 50% aerobic exercise, 50% resistance training; thrice a week for 60 min per dialysis session) and health literacy counselling (HLC) or control group/usual care (Usual care without any exercise intervention or HLC)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1211}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-29', 'studyFirstSubmitDate': '2019-03-18', 'studyFirstSubmitQcDate': '2019-03-19', 'lastUpdatePostDateStruct': {'date': '2022-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sit-to-stand test (STS60)', 'timeFrame': 'between baseline and 12 months', 'description': 'Change of Sit-to-stand test (STS 60) (number of repetitions in 60 seconds)'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '12 months', 'description': 'Defined as time from center randomization until death from any cause, or as time from center randomization until the patient was last alive (censored observations).'}, {'measure': '3-point MACE', 'timeFrame': '12 months', 'description': 'a composite of cardiovascular death, non-fatal stroke, or non-fatal myocardial infarction'}, {'measure': 'sudden death', 'timeFrame': '12 months', 'description': 'Patients alive will be considered as censored observations, and death from other causes will be considered as a competing event'}, {'measure': 'Sit-to-stand test (STS60)', 'timeFrame': '3, 6 and 9 months', 'description': 'measured in number of repetitions in 60 seconds'}, {'measure': 'Timed-up-and-go test (TUG)', 'timeFrame': '3, 6, 9, and 12 months', 'description': 'measured in time (seconds)'}, {'measure': 'Six-Minutes-Walk test (6MWT)', 'timeFrame': '3, 6, 9, and 12 months', 'description': 'measured in distance (meter)'}, {'measure': 'Grip strength test (GST)', 'timeFrame': '3, 6, 9, and 12 months', 'description': 'measured in kilogram'}, {'measure': 'hospitalizations', 'timeFrame': '12 months', 'description': 'measured in number and days of hospitalization for comorbidities'}, {'measure': 'frailty by Multidimensional Prognostic Index (MPI)', 'timeFrame': '3,6 and 12 months', 'description': 'measured in change of scale in questionnaire'}, {'measure': 'Serum phosphate', 'timeFrame': '3, 6, 9 and 12 months', 'description': 'measured in mmol/L'}, {'measure': 'Erythropoietin dose', 'timeFrame': '3, 6, 9, and 12 months', 'description': 'measured in IE/week'}, {'measure': 'Quality of life by SF-36', 'timeFrame': '3, 6 and 12 months', 'description': 'measured in change of scale by questionnaire'}, {'measure': 'Health literacy by HLS-EU-Q16', 'timeFrame': '3, 6 and 12 months', 'description': 'measured in change of scale in questionnaire'}, {'measure': 'health economics by medication', 'timeFrame': '12 months', 'description': 'measured in total costs between between study arms'}, {'measure': 'health economics by hospitalization', 'timeFrame': '12 months', 'description': 'measured in days in hospital between between study arms'}, {'measure': 'health economics by transportation', 'timeFrame': '12 months', 'description': 'measured in total costs between between study arms'}, {'measure': 'health economics by medical assistance tools', 'timeFrame': '12 months', 'description': 'measured in total costs between between study arms'}, {'measure': 'health economics by nursing', 'timeFrame': '12 months', 'description': 'measured in total costs between between study arms'}, {'measure': 'health economics by sick leave from workplace', 'timeFrame': '12 months', 'description': 'measured in days between between study arms'}, {'measure': 'needle dislocation/ catheter disconnection', 'timeFrame': '12 months', 'description': 'number of dialysis needle dislocation/ dialysis catheter disconnection'}, {'measure': 'symptomatic hypotensive episodes', 'timeFrame': '12 months', 'description': 'number of symptomatic hypotensive episodes'}, {'measure': 'cramps', 'timeFrame': '12 months', 'description': 'number of cramps'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic kidney disease', 'hemodialysis', 'intradialytic exercise', 'physical activity', 'safety', 'health economics', 'health literacy', 'training therapy'], 'conditions': ['Chronic Kidney Diseases', 'Hemodialysis']}, 'referencesModule': {'references': [{'pmid': '34564306', 'type': 'RESULT', 'citation': 'von Gersdorff G, von Korn P, Duvinage A, Ihorst G, Josef A, Kaufmann M, Baer T, Fellerhoff T, Fuhrmann I, Koesel E, Zeissler S, Bobka L, Heinrich M, Schindler A, Weber R, Breuer C, Meyer AM, Polidori MC, Dinges SMT, Schoenfeld J, Siebenbuerger M, Degenhardt S, Anding-Rost K, Halle M. Cluster Randomized Controlled Trial on the Effects of 12 Months of Combined Exercise Training during Hemodialysis in Patients with Chronic Kidney Disease-Study Protocol of the Dialysis Training Therapy (DiaTT) Trial. Methods Protoc. 2021 Aug 31;4(3):60. doi: 10.3390/mps4030060.'}, {'pmid': '38320198', 'type': 'DERIVED', 'citation': 'Anding-Rost K, von Gersdorff G, von Korn P, Ihorst G, Josef A, Kaufmann M, Huber M, Bar T, Zeissler S, Hofling S, Breuer C, Gartner N, Haykowsky MJ, Degenhardt S, Wanner C, Halle M. Exercise during Hemodialysis in Patients with Chronic Kidney Failure. NEJM Evid. 2023 Sep;2(9):EVIDoa2300057. doi: 10.1056/EVIDoa2300057. Epub 2023 Jun 17.'}]}, 'descriptionModule': {'briefSummary': 'DiaTT is an interventional, cluster-randomized (1:1), multicenter trial for patients with chronic kidney disease undergoing hemodialysis (n=1,100). This trial will test the effectiveness (by change of sit-to-stand test between baseline and 12 months) of intradialytic exercise training (ET) and health literacy counseling (HLC) for 12 months (Intervention group) in comparison to control group (usual care, UC; no ET, no HLC).', 'detailedDescription': "The primary objective of this trial is to assess the effectiveness of intradialytic exercise training (ET) and health literacy counselling (HLC) over 12 months intervention in patients undergoing chronic outpatient hemodialysis as compared to usual care (UC). The primary endpoint is change in Sit-to-Stand (STS60) test, from baseline to after 12 months intervention. The ET consists of both resistance and endurance training, focusing on improving patients' health status and physical functioning. Health literacy counseling aims at improving education, proficiency and self-awareness of the patient.\n\nAll patients undergoing hemodialysis in participating centers (clusters) for at least four weeks are eligible to participate in the study. Irrespective of randomized center (cluster) group assignment, all dialysis and overall medical treatments will remain unchanged and follow standard of care and center routine without adaptations to the training intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥ 18 years of age\n* chronic ambulatory hemodialysis for \\> 4 weeks\n* Written and signed confirmation by the treating dialysis physician that the patient is able to exercise\n* signed informed consent to participation in QiN registry\n* signed informed consent obtained according to confidentiality and data protection regulation, international guidelines and local laws\n\nExclusion Criteria:\n\n* Unstable angina pectoris\n* Uncontrolled arterial hypertension (systolic blood pressure \\> 180 mmHg or diastolic BP \\> 105 mmHg on repeated measurements)\n* Uncontrolled tachycardia\n* Acute severe infection\n* Planned live kidney transplantation within the next 12 months\n* Planned conversion to home-hemodialysis or peritoneal dialysis within the next 12 months\n* Dialyzing in long overnight dialysis shift\n* Participation in a regular exercise program during hemodialysis sessions (≥ 1/week) in the last 6 months'}, 'identificationModule': {'nctId': 'NCT03885102', 'acronym': 'DiaTT', 'briefTitle': 'Dialysis Training Therapy: The DiaTT Trial', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'Exercise During Hemodialysis: The Dialysis Training Therapy (DiaTT) Trial', 'orgStudyIdInfo': {'id': '509/18S-KK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': '12 months intradialytic exercise intervention', 'interventionNames': ['Behavioral: Intradialytic exercise intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care', 'description': 'Usual care according to current guidelines', 'interventionNames': ['Behavioral: Usual Care']}], 'interventions': [{'name': 'Intradialytic exercise intervention', 'type': 'BEHAVIORAL', 'description': '50% aerobic exercise, 50% resistance training thrice a week for 60 min per dialysis session, and health literacy counselling', 'armGroupLabels': ['Intervention']}, {'name': 'Usual Care', 'type': 'BEHAVIORAL', 'description': 'Usual care with no exercise intervention or health literacy counselling', 'armGroupLabels': ['Usual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92224', 'city': 'Amberg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'KfH-Nierenzentrum', 'geoPoint': {'lat': 49.44287, 'lon': 11.86267}}, {'zip': '63741', 'city': 'Aschaffenburg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'KfH-Nierenzentrum', 'geoPoint': {'lat': 49.97704, 'lon': 9.15214}}, {'zip': '96050', 'city': 'Bamberg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'KfH-Nierenzentrum', 'geoPoint': {'lat': 49.89873, 'lon': 10.90067}}, {'zip': '96450', 'city': 'Coburg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'KfH-Nierenzentrum', 'geoPoint': {'lat': 50.25937, 'lon': 10.96384}}, {'zip': '85221', 'city': 'Dachau', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'KfH-Nierenzentrum', 'geoPoint': {'lat': 48.26, 'lon': 11.43402}}, {'zip': '85560', 'city': 'Ebersberg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'KfH-Nierenzentrum', 'geoPoint': {'lat': 48.0771, 'lon': 11.97063}}, {'zip': '85354', 'city': 'Freising', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'KfH-Nierenzentrum', 'geoPoint': {'lat': 48.40351, 'lon': 11.74876}}, {'zip': '94081', 'city': 'Fürstenzell', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'KfH-Nierenzentrum', 'geoPoint': {'lat': 48.52163, 'lon': 13.31749}}, {'zip': '90766', 'city': 'Fürth', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'KfH-Nierenzentrum', 'geoPoint': {'lat': 49.47593, 'lon': 10.98856}}, {'zip': '80804', 'city': 'München', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'KfH-Nierenzentrum', 'geoPoint': {'lat': 48.69668, 'lon': 13.46314}}, {'zip': '94315', 'city': 'Straubing', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'KfH-Nierenzentrum', 'geoPoint': {'lat': 48.88126, 'lon': 12.57385}}, {'zip': '52074', 'city': 'Aachen', 'state': 'Northrhine', 'country': 'Germany', 'facility': 'KfH-Nierenzentrum', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '51465', 'city': 'Bergisch Gladbach', 'state': 'Northrhine', 'country': 'Germany', 'facility': 'KfH-Nierenzentrum', 'geoPoint': {'lat': 50.9856, 'lon': 7.13298}}, {'zip': '51149', 'city': 'Cologne', 'state': 'Northrhine', 'country': 'Germany', 'facility': 'KfH-Nierenzentrum', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '06120', 'city': 'Halle', 'state': 'Saxony-Anhalt', 'country': 'Germany', 'facility': 'KfH-Nierenzentrum', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': '39112', 'city': 'Magdeburg', 'state': 'Saxony-Anhalt', 'country': 'Germany', 'facility': 'KfH-Nierenzentrum', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'zip': '07745', 'city': 'Jena', 'state': 'Thuringia', 'country': 'Germany', 'facility': 'KfH-Nierenzentrum', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '96515', 'city': 'Sonneberg', 'state': 'Thuringia', 'country': 'Germany', 'facility': 'KfH-Nierenzentrum', 'geoPoint': {'lat': 50.3592, 'lon': 11.17463}}, {'zip': '44807', 'city': 'Bochum', 'state': 'Westphalia', 'country': 'Germany', 'facility': 'KfH-Nierenzentrum', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '58095', 'city': 'Hagen', 'state': 'Westphalia', 'country': 'Germany', 'facility': 'KfH-Nierenzentrum', 'geoPoint': {'lat': 51.36081, 'lon': 7.47168}}, {'zip': '45768', 'city': 'Marl', 'state': 'Westphalia', 'country': 'Germany', 'facility': 'KfH-Nierenzentrum', 'geoPoint': {'lat': 51.65671, 'lon': 7.09038}}], 'overallOfficials': [{'name': 'Gabriele Ihorst, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Clinical Trials Unit Freiburg, Medical Center, University of Freiburg'}, {'name': 'Gero von Gersdorff, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department II of Internal Medicine, University of Cologne'}, {'name': 'Kirsten Anding-Rost, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'KfH Kuratorium für Dialyse und Nierentransplantation e.V.'}, {'name': 'Martin Halle, Prof. MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Department of Prevention, Rehabilitation and Sports medicine, University hospital 'Klinikum rechts der Isar', Technical University of Munich"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prof. Dr. med. Martin Halle', 'class': 'OTHER'}, 'collaborators': [{'name': 'Technical University of Munich', 'class': 'OTHER'}, {'name': 'University Hospital of Cologne', 'class': 'OTHER'}, {'name': 'KfH Kuratorium für Dialyse und Nierentransplantation', 'class': 'UNKNOWN'}, {'name': 'Clinical Trials Unit Freiburg', 'class': 'OTHER'}, {'name': 'AOK PLUS', 'class': 'INDUSTRY'}, {'name': 'BARMER', 'class': 'OTHER'}, {'name': 'Techniker Krankenkasse', 'class': 'OTHER'}, {'name': 'Federal Joint Committee', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Univ.-Prof. MD', 'investigatorFullName': 'Prof. Dr. med. Martin Halle', 'investigatorAffiliation': 'Technical University of Munich'}}}}