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Dialysis Training Therapy: The DiaTT Trial (DiaTT)

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ClinicalTrials.gov Identifier: NCT03885102
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : September 11, 2019
Sponsor:
Collaborators:
Technische Universität München
University Hospital of Cologne
KfH Kuratorium für Dialyse und Nierentransplantation
Clinical Trials Unit Freiburg
AOK PLUS
BARMER
Techniker Krankenkasse
Federal Joint Committee, Germany
Information provided by (Responsible Party):
Prof. Dr. med. Martin Halle, Technische Universität München

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Hemodialysis Behavioral: Intradialytic exercise intervention Behavioral: Usual Care Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exercise During Hemodialysis: The Dialysis Training Therapy (DiaTT) Trial
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
12 months intradialytic exercise intervention
Behavioral: Intradialytic exercise intervention
50% aerobic exercise, 50% resistance training thrice a week for 60 min per dialysis session, and health literacy counselling

Active Comparator: Usual care
Usual care according to current guidelines
Behavioral: Usual Care
Usual care with no exercise intervention or health literacy counselling




Primary Outcome Measures :
  1. Sit-to-stand test (STS60) [ Time Frame: between baseline and 12 months ]
    Change of Sit-to-stand test (STS 60) (number of repetitions in 60 seconds)


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 12 months ]
    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).

  2. 3-point MACE [ Time Frame: 12 months ]
    a composite of cardiovascular death, non-fatal stroke, or non-fatal myocardial infarction

  3. sudden death [ Time Frame: 12 months ]
    Patients alive will be considered as censored observations, and death from other causes will be considered as a competing event

  4. Sit-to-stand test (STS60) [ Time Frame: 3, 6 and 9 months ]
    measured in number of repetitions in 60 seconds

  5. Timed-up-and-go test (TUG) [ Time Frame: 3, 6, 9, and 12 months ]
    measured in time (seconds)

  6. Six-Minutes-Walk test (6MWT) [ Time Frame: 3, 6, 9, and 12 months ]
    measured in distance (meter)

  7. Grip strength test (GST) [ Time Frame: 3, 6, 9, and 12 months ]
    measured in kilogram

  8. frailty by hospitalization [ Time Frame: 12 months ]
    measured in number and days of hospitalization for comorbidities

  9. frailty by Multidimensional Prognostic Index (MPI) [ Time Frame: 3,6 and 12 months ]
    measured in change of scale in questionnaire

  10. Serum phosphate [ Time Frame: 3, 6, 9 and 12 months ]
    measured in mmol/L

  11. Erythropoietin dose [ Time Frame: 3, 6, 9, and 12 months ]
    measured in IE/week

  12. Quality of life by SF-36 [ Time Frame: 3, 6 and 12 months ]
    measured in change of scale by questionnaire

  13. Health literacy by HLS-EU-Q16 [ Time Frame: 3, 6 and 12 months ]
    measured in change of scale in questionnaire

  14. health economics by medication [ Time Frame: 12 months ]
    measured in total costs between between study arms

  15. health economics by hospitalization [ Time Frame: 12 months ]
    measured in days in hospital between between study arms

  16. health economics by hospitalization [ Time Frame: 12 months ]
    measured in days in total costs between between study arms

  17. health economics by outpatient treatment [ Time Frame: 12 months ]
    measured in total costs between between study arms

  18. health economics by transportation [ Time Frame: 12 months ]
    measured in total costs between between study arms

  19. health economics by medical assistance tools [ Time Frame: 12 months ]
    measured in total costs between between study arms

  20. health economics by nursing [ Time Frame: 12 months ]
    measured in total costs between between study arms

  21. health economics by sick leave from workplace [ Time Frame: 12 months ]
    measured in days between between study arms

  22. needle dislocation/ catheter disconnection [ Time Frame: 12 months ]
    number of dialysis needle dislocation/ dialysis catheter disconnection

  23. symptomatic hypotensive episodes [ Time Frame: 12 months ]
    number of symptomatic hypotensive episodes

  24. cramps [ Time Frame: 12 months ]
    number of cramps



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients ≥ 18 years of age
  • chronic ambulatory hemodialysis for > 4 weeks
  • Written and signed confirmation by the treating dialysis physician that the patient is able to exercise
  • signed informed consent to participation in QiN registry
  • signed informed consent obtained according to confidentiality and data protection regulation, international guidelines and local laws

Exclusion Criteria:

  • Unstable angina pectoris
  • Uncontrolled arterial hypertension (systolic blood pressure > 180 mmHg or diastolic BP > 105 mmHg on repeated measurements)
  • Uncontrolled tachycardia
  • Acute severe infection
  • Planned live kidney transplantation within the next 12 months
  • Planned conversion to home-hemodialysis or peritoneal dialysis within the next 12 months
  • Dialyzing in long overnight dialysis shift
  • Participation in a regular exercise program during hemodialysis sessions (≥ 1/week) in the last 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885102


Contacts
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Contact: Martin Halle, Professor MD 0049 (0) 89 289 24431 Martin.Halle@mri.tum.de
Contact: Pia von Korn, MSc 0049 (0) 89 289 24454 Pia.vonKorn@mri.tum.de

Locations
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Germany
KfH-Nierenzentrum Recruiting
Amberg, Bavaria, Germany, 92224
Contact: Lothar Kornalik, MD         
KfH-Nierenzentrum Recruiting
Aschaffenburg, Bavaria, Germany, 63741
Contact: Birgit Rehbinder, MD         
KfH-Nierenzentrum Recruiting
Bamberg, Bavaria, Germany, 96050
Contact: Clemens Grupp, PD MD         
KfH-Nierenzentrum Recruiting
Coburg, Bavaria, Germany, 96450
Contact: Patrick Biggar, MD         
KfH-Nierenzentrum Recruiting
Dachau, Bavaria, Germany, 85221
Contact: Barbara Felgenträger, MD         
KfH-Nierenzentrum Not yet recruiting
Dillingen, Bavaria, Germany, 89407
Contact: Ulrike Bechtel, MD         
KfH-Nierenzentrum Recruiting
Ebersberg, Bavaria, Germany, 85560
Contact: Kathrin S Lange, MD         
KfH-Nierenzentrum Recruiting
Freising, Bavaria, Germany, 85354
Contact: Lavinia C. Lenhardt, MD         
KfH-Nierenzentrum Recruiting
Fürstenzell, Bavaria, Germany, 94081
Contact: Rüdiger Krallinger, MD         
Sub-Investigator: Holger Picker, MD         
KfH-Nierenzentrum Recruiting
Fürth, Bavaria, Germany, 90766
Contact: Beatrix Büschges-Seraphin, MD         
KfH-Nierenzentrum Recruiting
München, Bavaria, Germany, 80804
Contact: Johannes Mann, Prof. MD         
KfH-Nierenzentrum Not yet recruiting
Neusaß, Bavaria, Germany, 86356
Contact: Hella Gerber, MD         
KfH-Nierenzentrum Recruiting
Straubing, Bavaria, Germany, 94315
Contact: Marianne Haag-Weber, Prof MD         
KfH-Nierenzentrum Not yet recruiting
Aachen, Northrhine, Germany, 52074
Contact: Böhm Roland, MD         
KfH-Nierenzentrum Not yet recruiting
Bergisch Gladbach, Northrhine, Germany, 51465
Contact: Rainer Siewert, MD         
KfH-Nierenzentrum Not yet recruiting
Köln, Northrhine, Germany, 50737
Contact: Martin Gies         
KfH-Nierenzentrum Not yet recruiting
Köln, Northrhine, Germany, 50937
Contact: Tobias Marsen, PD MD         
Sub-Investigator: Oliver Schaffer, MD         
Sub-Investigator: Luise Schäfer, MD         
Sub-Investigator: Caroline Gurr, MD         
KfH-Nierenzentrum Not yet recruiting
Köln, Northrhine, Germany, 51149
Contact: Judith Schneider, MD         
KfH-Nierenzentrum Recruiting
Halle, Saxony-Anhalt, Germany, 06120
Contact: Matthias Girndt, Prof MD         
Sub-Investigator: Roman Fiedler, PD MD         
KfH-Nierenzentrum Recruiting
Magdeburg, Saxony-Anhalt, Germany, 39112
Contact: Carla Kreutze, MD         
KfH-Nierenzentrum Recruiting
Jena, Thuringia, Germany, 07745
Contact: Undine Ott, PD MD         
KfH-Nierenzentrum Not yet recruiting
Sonneberg, Thuringia, Germany, 96515
Contact: Henry Kämpf, MD         
KfH-Nierenzentrum Not yet recruiting
Bochum, Westphalia, Germany, 44807
Contact: Dirk Rattensperger, MD         
KfH-Nierenzentrum Not yet recruiting
Bottrop, Westphalia, Germany, 46242
Contact: Andre Voßkühler, MD         
KfH-Nierenzentrum Recruiting
Hagen, Westphalia, Germany, 58095
Contact: Alexander Weinreis, MD         
KfH-Nierenzentrum Recruiting
Marl, Westphalia, Germany, 45768
Contact: Birgit Rogowski         
Sponsors and Collaborators
Prof. Dr. med. Martin Halle
Technische Universität München
University Hospital of Cologne
KfH Kuratorium für Dialyse und Nierentransplantation
Clinical Trials Unit Freiburg
AOK PLUS
BARMER
Techniker Krankenkasse
Federal Joint Committee, Germany
Investigators
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Study Chair: 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.
Principal Investigator: Martin Halle, Prof. MD Department of Prevention, Rehabilitation and Sports medicine, University hospital 'Klinikum rechts der Isar', Technical University of Munich

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Responsible Party: Prof. Dr. med. Martin Halle, Univ.-Prof. MD, Technische Universität München
ClinicalTrials.gov Identifier: NCT03885102     History of Changes
Other Study ID Numbers: 509/18S-KK
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Dr. med. Martin Halle, Technische Universität München:
chronic kidney disease
hemodialysis
intradialytic exercise
physical activity
safety
health economics
health literacy
training therapy
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency