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.

Autor:	von Gersdorff G; QiN-Group, Department II of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, 50935 Cologne, Germany., von Korn P; Department of Prevention and Sports Medicine, Faculty of Medicine, University Hospital 'Klinikum rechts der Isar', Technical University Munich, 80992 Munich, Germany.; DZHK (Deutsches Zentrum für Herz-Kreislauf-Forschung), Partner Site Munich, Munich Heart Alliance, 80336 Munich, Germany., Duvinage A; Department of Prevention and Sports Medicine, Faculty of Medicine, University Hospital 'Klinikum rechts der Isar', Technical University Munich, 80992 Munich, Germany.; DZHK (Deutsches Zentrum für Herz-Kreislauf-Forschung), Partner Site Munich, Munich Heart Alliance, 80336 Munich, Germany., Ihorst G; Clinical Trials Unit, Faculty of Medicine and Medical Center, University of Freiburg, 79110 Freiburg, Germany., Josef A; Clinical Trials Unit, Faculty of Medicine and Medical Center, University of Freiburg, 79110 Freiburg, Germany., Kaufmann M; Clinical Trials Unit, Faculty of Medicine and Medical Center, University of Freiburg, 79110 Freiburg, Germany., Baer T; Department of Prevention and Sports Medicine, Faculty of Medicine, University Hospital 'Klinikum rechts der Isar', Technical University Munich, 80992 Munich, Germany.; Kuratorium für Dialyse und Nierentransplantation e.V. (KfH), 01877 Bischofswerda, Germany., Fellerhoff T; Department of Prevention and Sports Medicine, Faculty of Medicine, University Hospital 'Klinikum rechts der Isar', Technical University Munich, 80992 Munich, Germany., Fuhrmann I; Department of Prevention and Sports Medicine, Faculty of Medicine, University Hospital 'Klinikum rechts der Isar', Technical University Munich, 80992 Munich, Germany.; Deutsche Gesellschaft Rehabilitationssport für chronisch Nierenkranke e.V. (ReNi, Germany), 01445 Bischofswerda, Germany., Koesel E; Department of Prevention and Sports Medicine, Faculty of Medicine, University Hospital 'Klinikum rechts der Isar', Technical University Munich, 80992 Munich, Germany., Zeissler S; Department of Prevention and Sports Medicine, Faculty of Medicine, University Hospital 'Klinikum rechts der Isar', Technical University Munich, 80992 Munich, Germany.; Kuratorium für Dialyse und Nierentransplantation e.V. (KfH), 01877 Bischofswerda, Germany., Bobka L; BARMER, 01069 Dresden, Germany., Heinrich M; BARMER, 01069 Dresden, Germany., Schindler A; AOK PLUS, 01067 Dresden, Germany., Weber R; Techniker Krankenkasse, 22305 Hamburg, Germany., Breuer C; QiN-Group, Department II of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, 50935 Cologne, Germany., Meyer AM; Ageing Clinical Research, Department II of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, 50931 Cologne, Germany., Polidori MC; Ageing Clinical Research, Department II of Internal Medicine, Faculty of Medicine and University Hospital Cologne, University of Cologne, 50931 Cologne, Germany.; Center for Molecular Medicine Cologne, Faculty of Medicine and University Hospital Cologne, University of Cologne, 50931 Cologne, Germany.; Cologne Excellence Cluster on Cellular Stress-Responses in Aging-Associated Diseases (CECAD), Faculty of Medicine and University Hospital Cologne, University of Cologne, 50931 Cologne, Germany., Dinges SMT; Department of Prevention and Sports Medicine, Faculty of Medicine, University Hospital 'Klinikum rechts der Isar', Technical University Munich, 80992 Munich, Germany.; DZHK (Deutsches Zentrum für Herz-Kreislauf-Forschung), Partner Site Munich, Munich Heart Alliance, 80336 Munich, Germany., Schoenfeld J; Department of Prevention and Sports Medicine, Faculty of Medicine, University Hospital 'Klinikum rechts der Isar', Technical University Munich, 80992 Munich, Germany.; DZHK (Deutsches Zentrum für Herz-Kreislauf-Forschung), Partner Site Munich, Munich Heart Alliance, 80336 Munich, Germany., Siebenbuerger M; Department of Prevention and Sports Medicine, Faculty of Medicine, University Hospital 'Klinikum rechts der Isar', Technical University Munich, 80992 Munich, Germany., Degenhardt S; Deutsche Gesellschaft Rehabilitationssport für chronisch Nierenkranke e.V. (ReNi, Germany), 01445 Bischofswerda, Germany., Anding-Rost K; Department of Prevention and Sports Medicine, Faculty of Medicine, University Hospital 'Klinikum rechts der Isar', Technical University Munich, 80992 Munich, Germany.; Kuratorium für Dialyse und Nierentransplantation e.V. (KfH), 01877 Bischofswerda, Germany.; Deutsche Gesellschaft Rehabilitationssport für chronisch Nierenkranke e.V. (ReNi, Germany), 01445 Bischofswerda, Germany., Halle M; Department of Prevention and Sports Medicine, Faculty of Medicine, University Hospital 'Klinikum rechts der Isar', Technical University Munich, 80992 Munich, Germany.; DZHK (Deutsches Zentrum für Herz-Kreislauf-Forschung), Partner Site Munich, Munich Heart Alliance, 80336 Munich, Germany.
Jazyk:	angličtina
Zdroj:	Methods and protocols [Methods Protoc] 2021 Aug 31; Vol. 4 (3). Date of Electronic Publication: 2021 Aug 31.
DOI:	10.3390/mps4030060
Abstrakt:	Patients with chronic kidney disease (CKD) on hemodialysis (HD) experience treatment-related immobility and physical deconditioning, which is responsible for an increased risk of frailty and a high burden of multi-morbidity. Exercise has been shown to counteract this vicious cycle; however, its effectiveness has only been investigated in small cohorts. Therefore, the objective of the Dialysis Training Therapy (DiaTT) trial will be to assess the effects of a 12-month intradialytic exercise program on physical functioning, frailty and health economics in a large cohort of HD patients in a real-world setting. DiaTT will be a prospective, cluster-randomized (1:1), controlled, multi-center, interventional clinical trial across 28 dialysis units, aiming at the recruitment of >1100 CKD patients on HD. The intervention group will receive 12 months' intradialytic exercise (combined aerobic and resistance training), whereas the usual care group will not receive intervention. The primary endpoint will be a change on the sit-to-stand test (STS60) result between baseline and 12 months. Secondary endpoints will include physical functioning, frailty, quality of life, 3-point MACE, hospitalizations, survival, quality of HD, health literacy and health care costs. By including almost as many patients as previously investigated in smaller trials, DiaTT will be the largest randomized, controlled trial assessing frailty, quality of life and mortality in the field of nephrology.
Databáze:	MEDLINE
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