Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Technical University of Munich | OTHER |
| University Hospital of Cologne | OTHER |
| KfH Kuratorium für Dialyse und Nierentransplantation | UNKNOWN |
| Clinical Trials Unit Freiburg |
Not provided
Not provided
Not provided
Not provided
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).
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.
All 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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 12 months intradialytic exercise intervention |
|
| Usual care | Active Comparator | Usual care according to current guidelines |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intradialytic exercise intervention | Behavioral | 50% aerobic exercise, 50% resistance training thrice a week for 60 min per dialysis session, and health literacy counselling |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sit-to-stand test (STS60) | Change of Sit-to-stand test (STS 60) (number of repetitions in 60 seconds) | between baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 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). | 12 months |
| 3-point MACE |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gabriele Ihorst, PhD | Clinical Trials Unit Freiburg, Medical Center, University of Freiburg | Study Chair |
| Gero von Gersdorff, MD | Department II of Internal Medicine, University of Cologne | Study Chair |
| Kirsten Anding-Rost, MD | KfH Kuratorium für Dialyse und Nierentransplantation e.V. | Study Chair |
| Martin Halle, Prof. MD | Department of Prevention, Rehabilitation and Sports medicine, University hospital 'Klinikum rechts der Isar', Technical University of Munich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KfH-Nierenzentrum | Amberg | Bavaria | 92224 | Germany | ||
| KfH-Nierenzentrum |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34564306 | Result | 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. | |
| 38320198 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| OTHER |
| AOK PLUS | INDUSTRY |
| BARMER | OTHER |
| Techniker Krankenkasse | OTHER |
| Federal Joint Committee | OTHER_GOV |
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)
Not provided
Not provided
Not provided
Not provided
| Usual Care | Behavioral | Usual care with no exercise intervention or health literacy counselling |
|
a composite of cardiovascular death, non-fatal stroke, or non-fatal myocardial infarction
| 12 months |
| sudden death | Patients alive will be considered as censored observations, and death from other causes will be considered as a competing event | 12 months |
| Sit-to-stand test (STS60) | measured in number of repetitions in 60 seconds | 3, 6 and 9 months |
| Timed-up-and-go test (TUG) | measured in time (seconds) | 3, 6, 9, and 12 months |
| Six-Minutes-Walk test (6MWT) | measured in distance (meter) | 3, 6, 9, and 12 months |
| Grip strength test (GST) | measured in kilogram | 3, 6, 9, and 12 months |
| hospitalizations | measured in number and days of hospitalization for comorbidities | 12 months |
| frailty by Multidimensional Prognostic Index (MPI) | measured in change of scale in questionnaire | 3,6 and 12 months |
| Serum phosphate | measured in mmol/L | 3, 6, 9 and 12 months |
| Erythropoietin dose | measured in IE/week | 3, 6, 9, and 12 months |
| Quality of life by SF-36 | measured in change of scale by questionnaire | 3, 6 and 12 months |
| Health literacy by HLS-EU-Q16 | measured in change of scale in questionnaire | 3, 6 and 12 months |
| health economics by medication | measured in total costs between between study arms | 12 months |
| health economics by hospitalization | measured in days in hospital between between study arms | 12 months |
| health economics by transportation | measured in total costs between between study arms | 12 months |
| health economics by medical assistance tools | measured in total costs between between study arms | 12 months |
| health economics by nursing | measured in total costs between between study arms | 12 months |
| health economics by sick leave from workplace | measured in days between between study arms | 12 months |
| needle dislocation/ catheter disconnection | number of dialysis needle dislocation/ dialysis catheter disconnection | 12 months |
| symptomatic hypotensive episodes | number of symptomatic hypotensive episodes | 12 months |
| cramps | number of cramps | 12 months |
| Aschaffenburg |
| Bavaria |
| 63741 |
| Germany |
| KfH-Nierenzentrum | Bamberg | Bavaria | 96050 | Germany |
| KfH-Nierenzentrum | Coburg | Bavaria | 96450 | Germany |
| KfH-Nierenzentrum | Dachau | Bavaria | 85221 | Germany |
| KfH-Nierenzentrum | Ebersberg | Bavaria | 85560 | Germany |
| KfH-Nierenzentrum | Freising | Bavaria | 85354 | Germany |
| KfH-Nierenzentrum | Fürstenzell | Bavaria | 94081 | Germany |
| KfH-Nierenzentrum | Fürth | Bavaria | 90766 | Germany |
| KfH-Nierenzentrum | München | Bavaria | 80804 | Germany |
| KfH-Nierenzentrum | Straubing | Bavaria | 94315 | Germany |
| KfH-Nierenzentrum | Aachen | Northrhine | 52074 | Germany |
| KfH-Nierenzentrum | Bergisch Gladbach | Northrhine | 51465 | Germany |
| KfH-Nierenzentrum | Cologne | Northrhine | 51149 | Germany |
| KfH-Nierenzentrum | Halle | Saxony-Anhalt | 06120 | Germany |
| KfH-Nierenzentrum | Magdeburg | Saxony-Anhalt | 39112 | Germany |
| KfH-Nierenzentrum | Jena | Thuringia | 07745 | Germany |
| KfH-Nierenzentrum | Sonneberg | Thuringia | 96515 | Germany |
| KfH-Nierenzentrum | Bochum | Westphalia | 44807 | Germany |
| KfH-Nierenzentrum | Hagen | Westphalia | 58095 | Germany |
| KfH-Nierenzentrum | Marl | Westphalia | 45768 | Germany |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
Not provided
Not provided