Dialysis Training Therapy: The DiaTT Trial

NCT03885102 | Completed DMC

• 1 other identifier: 509/18S-KK
• Study Type: interventional
• Target: 1,211
• Locations: 1 country
• Sites: 21

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).

Conditions

Chronic Kidney Diseases; Hemodialysis

Keywords

chronic kidney disease; hemodialysis; intradialytic exercise; physical activity; safety; health economics; health literacy; training therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (22)

• Overall survival

  12 months

• 3-point MACE

  12 months

• sudden death

  12 months

• Sit-to-stand test (STS60)

  3, 6 and 9 months

• Timed-up-and-go test (TUG)

  3, 6, 9, and 12 months

Study Arms (2)

Intervention

EXPERIMENTAL

12 months intradialytic exercise intervention

Behavioral: Intradialytic exercise intervention

Usual care

ACTIVE COMPARATOR

Usual care according to current guidelines

Behavioral: Usual Care

Interventions

Intradialytic exercise intervention BEHAVIORAL

50% aerobic exercise, 50% resistance training thrice a week for 60 min per dialysis session, and health literacy counselling

Intervention

Usual Care BEHAVIORAL

Usual care with no exercise intervention or health literacy counselling

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (21)

KfH-Nierenzentrum

Amberg, Bavaria, 92224, Germany

Location

KfH-Nierenzentrum

Aschaffenburg, Bavaria, 63741, Germany

Location

KfH-Nierenzentrum

Bamberg, Bavaria, 96050, Germany

Location

KfH-Nierenzentrum

Coburg, Bavaria, 96450, Germany

Location

KfH-Nierenzentrum

Dachau, Bavaria, 85221, Germany

Location

KfH-Nierenzentrum

Ebersberg, Bavaria, 85560, Germany

Location

KfH-Nierenzentrum

Freising, Bavaria, 85354, Germany

Location

KfH-Nierenzentrum

Fürstenzell, Bavaria, 94081, Germany

Location

KfH-Nierenzentrum

Fürth, Bavaria, 90766, Germany

Location

KfH-Nierenzentrum

München, Bavaria, 80804, Germany

Location

KfH-Nierenzentrum

Straubing, Bavaria, 94315, Germany

Location

KfH-Nierenzentrum

Aachen, Northrhine, 52074, Germany

Location

KfH-Nierenzentrum

Bergisch Gladbach, Northrhine, 51465, Germany

Location

KfH-Nierenzentrum

Cologne, Northrhine, 51149, Germany

Location

KfH-Nierenzentrum

Halle, Saxony-Anhalt, 06120, Germany

Location

KfH-Nierenzentrum

Magdeburg, Saxony-Anhalt, 39112, Germany

Location

KfH-Nierenzentrum

Jena, Thuringia, 07745, Germany

Location

KfH-Nierenzentrum

Sonneberg, Thuringia, 96515, Germany

Location

KfH-Nierenzentrum

Bochum, Westphalia, 44807, Germany

Location

KfH-Nierenzentrum

Hagen, Westphalia, 58095, Germany

Location

KfH-Nierenzentrum

Marl, Westphalia, 45768, Germany

Location

Related Publications (2)

• 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.

  PMID: 34564306 RESULT

• 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.

  PMID: 38320198 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Motor Activity

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Univ.-Prof. MD

Model Details: 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)

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: March 21, 2019
• Study Start: April 1, 2019
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: December 2, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (21)