Dialysis Training Therapy: The DiaTT Trial

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.

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