An interventional study of Intradialytic exercise intervention and Usual Care in Chronic Kidney Diseases and Hemodialysis, sponsored by Prof. Dr. med. Martin Halle. Completed at 21 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-02.
Sponsored by Prof. Dr. med. Martin Halle · Not applicable, Interventional, and Treatment
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.
3,224 studies on the registry are indexed under Renal Insufficiency, Chronic; 706 are open to participants now.
This study's enrollment of 1,211 is above the median of 74 across 2,229 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →This is the only study on the registry with Prof. Dr. med. Martin Halle as lead sponsor.
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Exclusion Criteria:
12 months intradialytic exercise intervention
Behavioral: Intradialytic exercise intervention
Usual care according to current guidelines
Behavioral: Usual Care
50% aerobic exercise, 50% resistance training thrice a week for 60 min per dialysis session, and health literacy counselling
Usual care with no exercise intervention or health literacy counselling
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
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
hospitalizations
measured in number and days of hospitalization for comorbidities
Time frame: 12 months
frailty by Multidimensional Prognostic Index (MPI)
measured in change of scale in questionnaire
Time frame: 3,6 and 12 months
Serum phosphate
measured in mmol/L
Time frame: 3, 6, 9 and 12 months
Erythropoietin dose
measured in IE/week
Time frame: 3, 6, 9, and 12 months
Quality of life by SF-36
measured in change of scale by questionnaire
Time frame: 3, 6 and 12 months
Health literacy by HLS-EU-Q16
measured in change of scale in questionnaire
Time frame: 3, 6 and 12 months
health economics by medication
measured in total costs between between study arms
Time frame: 12 months
health economics by hospitalization
measured in days in hospital between between study arms
Time frame: 12 months
health economics by transportation
measured in total costs between between study arms
Time frame: 12 months
health economics by medical assistance tools
measured in total costs between between study arms
Time frame: 12 months
health economics by nursing
measured in total costs between between study arms
Time frame: 12 months
health economics by sick leave from workplace
measured in days between between study arms
Time frame: 12 months
needle dislocation/ catheter disconnection
number of dialysis needle dislocation/ dialysis catheter disconnection
Time frame: 12 months
symptomatic hypotensive episodes
number of symptomatic hypotensive episodes
Time frame: 12 months
cramps
number of cramps
Time frame: 12 months
Plan to share: No
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Renal Insufficiency, Chronic →