NCT03885102

Dialysis Training Therapy: The DiaTT Trial

Exercise During Hemodialysis: The Dialysis Training Therapy (DiaTT) Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,211 (actual)
• Sponsor: Prof. Dr. med. Martin Halle · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Kidney Diseases
• Hemodialysis

Interventions

Type	Name	Description
BEHAVIORAL	Intradialytic exercise intervention	50% aerobic exercise, 50% resistance training thrice a week for 60 min per dialysis session, and health literacy counselling
BEHAVIORAL	Usual Care	Usual care with no exercise intervention or health literacy counselling

Timeline

• Start date: 2019-04-01
• Primary completion: 2022-02-28
• Completion: 2022-02-28
• First posted: 2019-03-21
• Last updated: 2022-12-02

Locations

21 sites across 1 country: Germany