Clinical trial NCT03885102: Dialysis Training Therapy: The DiaTT Trial
Official title: Exercise During Hemodialysis: The Dialysis Training Therapy (DiaTT) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Diseases
Hemodialysis
Keywords: chronic kidney disease
hemodialysis
intradialytic exercise
physical activity
safety
health economics
health literacy
training therapy
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: Technical University of Munich
name: University Hospital of Cologne
name: KfH Kuratorium für Dialyse und Nierentransplantation
name: Clinical Trials Unit Freiburg
name: AOK PLUS
name: BARMER
name: Techniker Krankenkasse
name: Federal Joint Committee
First posted: 2019-03-21
Enrollment: 1211
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: TREATMENT

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).

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.

Eligibility 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

Primary outcomes:
measure: Sit-to-stand test (STS60)
timeFrame: between baseline and 12 months
Secondary outcomes:
measure: Overall survival
timeFrame: 12 months
measure: 3-point MACE
timeFrame: 12 months
measure: sudden death
timeFrame: 12 months
measure: Sit-to-stand test (STS60)
timeFrame: 3, 6 and 9 months
measure: Timed-up-and-go test (TUG)
timeFrame: 3, 6, 9, and 12 months
measure: Six-Minutes-Walk test (6MWT)
timeFrame: 3, 6, 9, and 12 months
measure: Grip strength test (GST)
timeFrame: 3, 6, 9, and 12 months
measure: hospitalizations
timeFrame: 12 months
measure: frailty by Multidimensional Prognostic Index (MPI)
timeFrame: 3,6 and 12 months
measure: Serum phosphate
timeFrame: 3, 6, 9 and 12 months
measure: Erythropoietin dose
timeFrame: 3, 6, 9, and 12 months
measure: Quality of life by SF-36
timeFrame: 3, 6 and 12 months
measure: Health literacy by HLS-EU-Q16
timeFrame: 3, 6 and 12 months
measure: health economics by medication
timeFrame: 12 months
measure: health economics by hospitalization
timeFrame: 12 months
measure: health economics by transportation
timeFrame: 12 months
measure: health economics by medical assistance tools
timeFrame: 12 months
measure: health economics by nursing
timeFrame: 12 months
measure: health economics by sick leave from workplace
timeFrame: 12 months
measure: needle dislocation/ catheter disconnection
timeFrame: 12 months
measure: symptomatic hypotensive episodes
timeFrame: 12 months
measure: cramps
timeFrame: 12 months
Other outcomes:
Locations:
city: Amberg
country: Germany
facility: KfH-Nierenzentrum
state: Bavaria
city: Aschaffenburg
country: Germany
facility: KfH-Nierenzentrum
state: Bavaria
city: Bamberg
country: Germany
facility: KfH-Nierenzentrum
state: Bavaria
city: Coburg
country: Germany
facility: KfH-Nierenzentrum
state: Bavaria
city: Dachau
country: Germany
facility: KfH-Nierenzentrum
state: Bavaria
city: Ebersberg
country: Germany
facility: KfH-Nierenzentrum
state: Bavaria
city: Freising
country: Germany
facility: KfH-Nierenzentrum
state: Bavaria
city: Fürstenzell
country: Germany
facility: KfH-Nierenzentrum
state: Bavaria
city: Fürth
country: Germany
facility: KfH-Nierenzentrum
state: Bavaria
city: München
country: Germany
facility: KfH-Nierenzentrum
state: Bavaria
city: Straubing
country: Germany
facility: KfH-Nierenzentrum
state: Bavaria
city: Aachen
country: Germany
facility: KfH-Nierenzentrum
state: Northrhine
city: Bergisch Gladbach
country: Germany
facility: KfH-Nierenzentrum
state: Northrhine
city: Köln
country: Germany
facility: KfH-Nierenzentrum
state: Northrhine
city: Halle
country: Germany
facility: KfH-Nierenzentrum
state: Saxony-Anhalt
city: Magdeburg
country: Germany
facility: KfH-Nierenzentrum
state: Saxony-Anhalt
city: Jena
country: Germany
facility: KfH-Nierenzentrum
state: Thuringia
city: Sonneberg
country: Germany
facility: KfH-Nierenzentrum
state: Thuringia
city: Bochum
country: Germany
facility: KfH-Nierenzentrum
state: Westphalia
city: Hagen
country: Germany
facility: KfH-Nierenzentrum
state: Westphalia
city: Marl
country: Germany
facility: KfH-Nierenzentrum
state: Westphalia
Study officials:
affiliation: Clinical Trials Unit Freiburg, Medical Center, University of Freiburg
name: Gabriele Ihorst, PhD
role: STUDY_CHAIR
affiliation: Department II of Internal Medicine, University of Cologne
name: Gero von Gersdorff, MD
role: STUDY_CHAIR
affiliation: KfH Kuratorium für Dialyse und Nierentransplantation e.V.
name: Kirsten Anding-Rost, MD
role: STUDY_CHAIR
affiliation: Department of Prevention, Rehabilitation and Sports medicine, University hospital 'Klinikum rechts der Isar', Technical University of Munich
name: Martin Halle, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
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.