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Exercise During Hemodialysis: The Dialysis Training Therapy (DiaTT) Trial
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
KfH-Nierenzentrum
Amberg, Bavaria, Germany
KfH-Nierenzentrum
Aschaffenburg, Bavaria, Germany
KfH-Nierenzentrum
Bamberg, Bavaria, Germany
KfH-Nierenzentrum
Coburg, Bavaria, Germany
KfH-Nierenzentrum
Dachau, Bavaria, Germany
KfH-Nierenzentrum
Ebersberg, Bavaria, Germany
KfH-Nierenzentrum
Freising, Bavaria, Germany
KfH-Nierenzentrum
Fürstenzell, Bavaria, Germany
KfH-Nierenzentrum
Fürth, Bavaria, Germany
KfH-Nierenzentrum
München, Bavaria, Germany
Start Date
April 1, 2019
Primary Completion Date
February 28, 2022
Completion Date
February 28, 2022
Last Updated
December 2, 2022
1,211
ACTUAL participants
Intradialytic exercise intervention
BEHAVIORAL
Usual Care
BEHAVIORAL
Lead Sponsor
Prof. Dr. med. Martin Halle
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07094906