Dialysis Training Therapy: The DiaTT Trial

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Kidney Diseases, Hemodialysis

Intervention / Treatment
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* Behavioral: Intradialytic exercise intervention
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>12 months intradialytic exercise intervention | Behavioral: Intradialytic exercise intervention<br>* 50% aerobic exercise, 50% resistance training thrice a week for 60 min per dialysis session, and health literacy counselling<br>|
| Active Comparator: Usual care<br>Usual care according to current guidelines | Behavioral: Usual Care<br>* Usual care with no exercise intervention or health literacy counselling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sit-to-stand test (STS60) | Change of Sit-to-stand test (STS 60) (number of repetitions in 60 seconds) | between baseline and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 12 months | 
| 3-point MACE | a composite of cardiovascular death, non-fatal stroke, or non-fatal myocardial infarction | 12 months | 
| sudden death | Patients alive will be considered as censored observations, and death from other causes will be considered as a competing event | 12 months | 
| Sit-to-stand test (STS60) | measured in number of repetitions in 60 seconds | 3, 6 and 9 months | 
| Timed-up-and-go test (TUG) | measured in time (seconds) | 3, 6, 9, and 12 months | 
| Six-Minutes-Walk test (6MWT) | measured in distance (meter) | 3, 6, 9, and 12 months | 
| Grip strength test (GST) | measured in kilogram | 3, 6, 9, and 12 months | 
| hospitalizations | measured in number and days of hospitalization for comorbidities | 12 months | 
| frailty by Multidimensional Prognostic Index (MPI) | measured in change of scale in questionnaire | 3,6 and 12 months | 
| Serum phosphate | measured in mmol/L | 3, 6, 9 and 12 months | 
| Erythropoietin dose | measured in IE/week | 3, 6, 9, and 12 months | 
| Quality of life by SF-36 | measured in change of scale by questionnaire | 3, 6 and 12 months | 
| Health literacy by HLS-EU-Q16 | measured in change of scale in questionnaire | 3, 6 and 12 months | 
| health economics by medication | measured in total costs between between study arms | 12 months | 
| health economics by hospitalization | measured in days in hospital between between study arms | 12 months | 
| health economics by transportation | measured in total costs between between study arms | 12 months | 
| health economics by medical assistance tools | measured in total costs between between study arms | 12 months | 
| health economics by nursing | measured in total costs between between study arms | 12 months | 
| health economics by sick leave from workplace | measured in days between between study arms | 12 months | 
| needle dislocation/ catheter disconnection | number of dialysis needle dislocation/ dialysis catheter disconnection | 12 months | 
| symptomatic hypotensive episodes | number of symptomatic hypotensive episodes | 12 months | 
| cramps | number of cramps | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic kidney disease, hemodialysis, intradialytic exercise, physical activity, safety, health economics, health literacy, training therapy