search
Back to results

Dialysis Training Therapy: The DiaTT Trial (DiaTT)

Primary Purpose

Chronic Kidney Diseases, Hemodialysis

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Intradialytic exercise intervention
Usual Care
Sponsored by
Prof. Dr. med. Martin Halle
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring chronic kidney disease, hemodialysis, intradialytic exercise, physical activity, safety, health economics, health literacy, training therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • KfH-Nierenzentrum
  • KfH-Nierenzentrum
  • KfH-Nierenzentrum
  • KfH-Nierenzentrum
  • KfH-Nierenzentrum
  • KfH-Nierenzentrum
  • KfH-Nierenzentrum
  • KfH-Nierenzentrum
  • KfH-Nierenzentrum
  • KfH-Nierenzentrum
  • KfH-Nierenzentrum
  • KfH-Nierenzentrum
  • KfH-Nierenzentrum
  • KfH-Nierenzentrum
  • KfH-Nierenzentrum
  • KfH-Nierenzentrum
  • KfH-Nierenzentrum
  • KfH-Nierenzentrum
  • KfH-Nierenzentrum
  • KfH-Nierenzentrum
  • KfH-Nierenzentrum

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Usual care

Arm Description

12 months intradialytic exercise intervention

Usual care according to current guidelines

Outcomes

Primary Outcome Measures

Sit-to-stand test (STS60)
Change of Sit-to-stand test (STS 60) (number of repetitions in 60 seconds)

Secondary Outcome Measures

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).
3-point MACE
a composite of cardiovascular death, non-fatal stroke, or non-fatal myocardial infarction
sudden death
Patients alive will be considered as censored observations, and death from other causes will be considered as a competing event
Sit-to-stand test (STS60)
measured in number of repetitions in 60 seconds
Timed-up-and-go test (TUG)
measured in time (seconds)
Six-Minutes-Walk test (6MWT)
measured in distance (meter)
Grip strength test (GST)
measured in kilogram
hospitalizations
measured in number and days of hospitalization for comorbidities
frailty by Multidimensional Prognostic Index (MPI)
measured in change of scale in questionnaire
Serum phosphate
measured in mmol/L
Erythropoietin dose
measured in IE/week
Quality of life by SF-36
measured in change of scale by questionnaire
Health literacy by HLS-EU-Q16
measured in change of scale in questionnaire
health economics by medication
measured in total costs between between study arms
health economics by hospitalization
measured in days in hospital between between study arms
health economics by transportation
measured in total costs between between study arms
health economics by medical assistance tools
measured in total costs between between study arms
health economics by nursing
measured in total costs between between study arms
health economics by sick leave from workplace
measured in days between between study arms
needle dislocation/ catheter disconnection
number of dialysis needle dislocation/ dialysis catheter disconnection
symptomatic hypotensive episodes
number of symptomatic hypotensive episodes
cramps
number of cramps

Full Information

First Posted
March 18, 2019
Last Updated
November 29, 2022
Sponsor
Prof. Dr. med. Martin Halle
Collaborators
Technical University of Munich, University Hospital of Cologne, KfH Kuratorium für Dialyse und Nierentransplantation, Clinical Trials Unit Freiburg, AOK PLUS, BARMER, Techniker Krankenkasse, Federal Joint Committee
search

1. Study Identification

Unique Protocol Identification Number
NCT03885102
Brief Title
Dialysis Training Therapy: The DiaTT Trial
Acronym
DiaTT
Official Title
Exercise During Hemodialysis: The Dialysis Training Therapy (DiaTT) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
February 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof. Dr. med. Martin Halle
Collaborators
Technical University of Munich, University Hospital of Cologne, KfH Kuratorium für Dialyse und Nierentransplantation, Clinical Trials Unit Freiburg, AOK PLUS, BARMER, Techniker Krankenkasse, Federal Joint Committee

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases, Hemodialysis
Keywords
chronic kidney disease, hemodialysis, intradialytic exercise, physical activity, safety, health economics, health literacy, training therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
1211 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
12 months intradialytic exercise intervention
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Usual care according to current guidelines
Intervention Type
Behavioral
Intervention Name(s)
Intradialytic exercise intervention
Intervention Description
50% aerobic exercise, 50% resistance training thrice a week for 60 min per dialysis session, and health literacy counselling
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Usual care with no exercise intervention or health literacy counselling
Primary Outcome Measure Information:
Title
Sit-to-stand test (STS60)
Description
Change of Sit-to-stand test (STS 60) (number of repetitions in 60 seconds)
Time Frame
between baseline and 12 months
Secondary Outcome Measure Information:
Title
Overall survival
Description
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).
Time Frame
12 months
Title
3-point MACE
Description
a composite of cardiovascular death, non-fatal stroke, or non-fatal myocardial infarction
Time Frame
12 months
Title
sudden death
Description
Patients alive will be considered as censored observations, and death from other causes will be considered as a competing event
Time Frame
12 months
Title
Sit-to-stand test (STS60)
Description
measured in number of repetitions in 60 seconds
Time Frame
3, 6 and 9 months
Title
Timed-up-and-go test (TUG)
Description
measured in time (seconds)
Time Frame
3, 6, 9, and 12 months
Title
Six-Minutes-Walk test (6MWT)
Description
measured in distance (meter)
Time Frame
3, 6, 9, and 12 months
Title
Grip strength test (GST)
Description
measured in kilogram
Time Frame
3, 6, 9, and 12 months
Title
hospitalizations
Description
measured in number and days of hospitalization for comorbidities
Time Frame
12 months
Title
frailty by Multidimensional Prognostic Index (MPI)
Description
measured in change of scale in questionnaire
Time Frame
3,6 and 12 months
Title
Serum phosphate
Description
measured in mmol/L
Time Frame
3, 6, 9 and 12 months
Title
Erythropoietin dose
Description
measured in IE/week
Time Frame
3, 6, 9, and 12 months
Title
Quality of life by SF-36
Description
measured in change of scale by questionnaire
Time Frame
3, 6 and 12 months
Title
Health literacy by HLS-EU-Q16
Description
measured in change of scale in questionnaire
Time Frame
3, 6 and 12 months
Title
health economics by medication
Description
measured in total costs between between study arms
Time Frame
12 months
Title
health economics by hospitalization
Description
measured in days in hospital between between study arms
Time Frame
12 months
Title
health economics by transportation
Description
measured in total costs between between study arms
Time Frame
12 months
Title
health economics by medical assistance tools
Description
measured in total costs between between study arms
Time Frame
12 months
Title
health economics by nursing
Description
measured in total costs between between study arms
Time Frame
12 months
Title
health economics by sick leave from workplace
Description
measured in days between between study arms
Time Frame
12 months
Title
needle dislocation/ catheter disconnection
Description
number of dialysis needle dislocation/ dialysis catheter disconnection
Time Frame
12 months
Title
symptomatic hypotensive episodes
Description
number of symptomatic hypotensive episodes
Time Frame
12 months
Title
cramps
Description
number of cramps
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriele Ihorst, PhD
Organizational Affiliation
Clinical Trials Unit Freiburg, Medical Center, University of Freiburg
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gero von Gersdorff, MD
Organizational Affiliation
Department II of Internal Medicine, University of Cologne
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kirsten Anding-Rost, MD
Organizational Affiliation
KfH Kuratorium für Dialyse und Nierentransplantation e.V.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Martin Halle, Prof. MD
Organizational Affiliation
Department of Prevention, Rehabilitation and Sports medicine, University hospital 'Klinikum rechts der Isar', Technical University of Munich
Official's Role
Principal Investigator
Facility Information:
Facility Name
KfH-Nierenzentrum
City
Amberg
State/Province
Bavaria
ZIP/Postal Code
92224
Country
Germany
Facility Name
KfH-Nierenzentrum
City
Aschaffenburg
State/Province
Bavaria
ZIP/Postal Code
63741
Country
Germany
Facility Name
KfH-Nierenzentrum
City
Bamberg
State/Province
Bavaria
ZIP/Postal Code
96050
Country
Germany
Facility Name
KfH-Nierenzentrum
City
Coburg
State/Province
Bavaria
ZIP/Postal Code
96450
Country
Germany
Facility Name
KfH-Nierenzentrum
City
Dachau
State/Province
Bavaria
ZIP/Postal Code
85221
Country
Germany
Facility Name
KfH-Nierenzentrum
City
Ebersberg
State/Province
Bavaria
ZIP/Postal Code
85560
Country
Germany
Facility Name
KfH-Nierenzentrum
City
Freising
State/Province
Bavaria
ZIP/Postal Code
85354
Country
Germany
Facility Name
KfH-Nierenzentrum
City
Fürstenzell
State/Province
Bavaria
ZIP/Postal Code
94081
Country
Germany
Facility Name
KfH-Nierenzentrum
City
Fürth
State/Province
Bavaria
ZIP/Postal Code
90766
Country
Germany
Facility Name
KfH-Nierenzentrum
City
München
State/Province
Bavaria
ZIP/Postal Code
80804
Country
Germany
Facility Name
KfH-Nierenzentrum
City
Straubing
State/Province
Bavaria
ZIP/Postal Code
94315
Country
Germany
Facility Name
KfH-Nierenzentrum
City
Aachen
State/Province
Northrhine
ZIP/Postal Code
52074
Country
Germany
Facility Name
KfH-Nierenzentrum
City
Bergisch Gladbach
State/Province
Northrhine
ZIP/Postal Code
51465
Country
Germany
Facility Name
KfH-Nierenzentrum
City
Köln
State/Province
Northrhine
ZIP/Postal Code
51149
Country
Germany
Facility Name
KfH-Nierenzentrum
City
Halle
State/Province
Saxony-Anhalt
ZIP/Postal Code
06120
Country
Germany
Facility Name
KfH-Nierenzentrum
City
Magdeburg
State/Province
Saxony-Anhalt
ZIP/Postal Code
39112
Country
Germany
Facility Name
KfH-Nierenzentrum
City
Jena
State/Province
Thuringia
ZIP/Postal Code
07745
Country
Germany
Facility Name
KfH-Nierenzentrum
City
Sonneberg
State/Province
Thuringia
ZIP/Postal Code
96515
Country
Germany
Facility Name
KfH-Nierenzentrum
City
Bochum
State/Province
Westphalia
ZIP/Postal Code
44807
Country
Germany
Facility Name
KfH-Nierenzentrum
City
Hagen
State/Province
Westphalia
ZIP/Postal Code
58095
Country
Germany
Facility Name
KfH-Nierenzentrum
City
Marl
State/Province
Westphalia
ZIP/Postal Code
45768
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34564306
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.
Results Reference
result

Learn more about this trial

Dialysis Training Therapy: The DiaTT Trial

We'll reach out to this number within 24 hrs