Dialysis Training Therapy: The DiaTT Trial

Prof. Dr. med. Martin Halle1,211 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,211

Conditions

Chronic Kidney Diseases Hemodialysis

Interventions

Intradialytic exercise interventionBEHAVIORAL

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

Usual CareBEHAVIORAL

Usual care with no exercise intervention or health literacy counselling

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (21)

KfH-Nierenzentrum

Amberg, Bavaria, Germany

KfH-Nierenzentrum

Aschaffenburg, Bavaria, Germany

Outcomes

Primary Outcomes

Sit-to-stand test (STS60)

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

Time frame: between baseline and 12 months

Secondary Outcomes

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).

Time frame: 12 months

3-point MACE

a composite of cardiovascular death, non-fatal stroke, or non-fatal myocardial infarction

Time frame: 12 months

sudden death

Patients alive will be considered as censored observations, and death from other causes will be considered as a competing event

Time frame: 12 months

Sit-to-stand test (STS60)

measured in number of repetitions in 60 seconds

Time frame: 3, 6 and 9 months

Timed-up-and-go test (TUG)

measured in time (seconds)

Time frame: 3, 6, 9, and 12 months

Six-Minutes-Walk test (6MWT)

measured in distance (meter)

Time frame: 3, 6, 9, and 12 months

Grip strength test (GST)

measured in kilogram

Time frame: 3, 6, 9, and 12 months

Data from ClinicalTrials.gov

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