Dialysis Training Therapy: The DiaTT Trial
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 1100
Summary
- Conditions
- Chronic Kidney Diseases
- Hemodialysis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT03885102
- Collaborators
- Technische Universität München
- University Hospital of Cologne
- KfH Kuratorium für Dialyse und Nierentransplantation
- Clinical Trials Unit Freiburg
- AOK PLUS
- BARMER
- Techniker Krankenkasse
- Federal Joint Committee
- Investigators
- Study Chair: 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. Principal Investigator: Martin Halle, Prof. MD Department of Prevention, Rehabilitation and Sports medicine, University hospital 'Klinikum rechts der Isar', Technical University of Munich
Get Well Soon