Dialysis Training Therapy: The DiaTT Trial (DiaTT)

Exercise During Hemodialysis: The Dialysis Training Therapy (DiaTT) Trial

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).

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Diseases; Hemodialysis
• Intervention / Treatment: Behavioral: Intradialytic exercise intervention; Behavioral: Usual Care

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.

• Study Type: Interventional
• Enrollment (Actual): 1211
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Amberg, Bavaria, Germany, 92224
      • KfH-Nierenzentrum
    • Aschaffenburg, Bavaria, Germany, 63741
      • KfH-Nierenzentrum
    • Bamberg, Bavaria, Germany, 96050
      • KfH-Nierenzentrum
    • Coburg, Bavaria, Germany, 96450
      • KfH-Nierenzentrum
    • Dachau, Bavaria, Germany, 85221
      • KfH-Nierenzentrum
    • Ebersberg, Bavaria, Germany, 85560
      • KfH-Nierenzentrum
    • Freising, Bavaria, Germany, 85354
      • KfH-Nierenzentrum
    • Fürstenzell, Bavaria, Germany, 94081
      • KfH-Nierenzentrum
    • Fürth, Bavaria, Germany, 90766
      • KfH-Nierenzentrum
    • München, Bavaria, Germany, 80804
      • KfH-Nierenzentrum
    • Straubing, Bavaria, Germany, 94315
      • KfH-Nierenzentrum
  • Northrhine
    • Aachen, Northrhine, Germany, 52074
      • KfH-Nierenzentrum
    • Bergisch Gladbach, Northrhine, Germany, 51465
      • KfH-Nierenzentrum
    • Köln, Northrhine, Germany, 51149
      • KfH-Nierenzentrum
  • Saxony-Anhalt
    • Halle, Saxony-Anhalt, Germany, 06120
      • KfH-Nierenzentrum
    • Magdeburg, Saxony-Anhalt, Germany, 39112
      • KfH-Nierenzentrum
  • Thuringia
    • Jena, Thuringia, Germany, 07745
      • KfH-Nierenzentrum
    • Sonneberg, Thuringia, Germany, 96515
      • KfH-Nierenzentrum
  • Westphalia
    • Bochum, Westphalia, Germany, 44807
      • KfH-Nierenzentrum
    • Hagen, Westphalia, Germany, 58095
      • KfH-Nierenzentrum
    • Marl, Westphalia, Germany, 45768
      • KfH-Nierenzentrum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Prof. Dr. med. Martin Halle
• Collaborators: Technical University of Munich; BARMER; University Hospital of Cologne; Techniker Krankenkasse; Federal Joint Committee; AOK PLUS; Clinical Trials Unit Freiburg; KfH Kuratorium für Dialyse und Nierentransplantation
• Investigators: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: March 18, 2019
• First Submitted That Met QC Criteria: March 19, 2019
• First Posted (Actual): March 21, 2019

Study Record Updates

• Last Update Posted (Actual): December 2, 2022
• Last Update Submitted That Met QC Criteria: November 29, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: physical activity; safety; chronic kidney disease; health literacy; hemodialysis; health economics; intradialytic exercise; training therapy
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 509/18S-KK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No