Dialysis Training Therapy: The DiaTT Trial
- Conditions
- Chronic Kidney DiseasesHemodialysis
- Interventions
- Behavioral: Intradialytic exercise interventionBehavioral: Usual Care
- Registration Number
- NCT03885102
- Lead Sponsor
- Prof. Dr. med. Martin Halle
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1211
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Intradialytic exercise intervention 12 months intradialytic exercise intervention Usual care Usual Care Usual care according to current guidelines
- Primary Outcome Measures
Name Time Method Sit-to-stand test (STS60) between baseline and 12 months Change of Sit-to-stand test (STS 60) (number of repetitions in 60 seconds)
- Secondary Outcome Measures
Name Time Method health economics by hospitalization 12 months measured in days in hospital between between study arms
sudden death 12 months Patients alive will be considered as censored observations, and death from other causes will be considered as a competing event
Timed-up-and-go test (TUG) 3, 6, 9, and 12 months measured in time (seconds)
Six-Minutes-Walk test (6MWT) 3, 6, 9, and 12 months measured in distance (meter)
Grip strength test (GST) 3, 6, 9, and 12 months measured in kilogram
hospitalizations 12 months measured in number and days of hospitalization for comorbidities
Serum phosphate 3, 6, 9 and 12 months measured in mmol/L
Overall survival 12 months 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).
health economics by transportation 12 months measured in total costs between between study arms
frailty by Multidimensional Prognostic Index (MPI) 3,6 and 12 months measured in change of scale in questionnaire
Quality of life by SF-36 3, 6 and 12 months measured in change of scale by questionnaire
Health literacy by HLS-EU-Q16 3, 6 and 12 months measured in change of scale in questionnaire
health economics by medication 12 months measured in total costs between between study arms
health economics by medical assistance tools 12 months measured in total costs between between study arms
health economics by nursing 12 months measured in total costs between between study arms
needle dislocation/ catheter disconnection 12 months number of dialysis needle dislocation/ dialysis catheter disconnection
symptomatic hypotensive episodes 12 months number of symptomatic hypotensive episodes
3-point MACE 12 months a composite of cardiovascular death, non-fatal stroke, or non-fatal myocardial infarction
Sit-to-stand test (STS60) 3, 6 and 9 months measured in number of repetitions in 60 seconds
Erythropoietin dose 3, 6, 9, and 12 months measured in IE/week
cramps 12 months number of cramps
health economics by sick leave from workplace 12 months measured in days between between study arms
Trial Locations
- Locations (1)
KfH-Nierenzentrum
🇩🇪Marl, Westphalia, Germany