Dialysis Training Therapy: The DiaTT Trial

Prof. Dr. med. Martin Halle

Status: Completed

Conditions: Chronic Kidney Diseases; Hemodialysis

Treatments: Behavioral: Usual Care; Behavioral: Intradialytic exercise intervention

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03885102

509/18S-KK

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1,211 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,211 participants in 2 patient groups

Intervention

Experimental group

Description:

12 months intradialytic exercise intervention

Treatment:

Behavioral: Intradialytic exercise intervention

Usual care

Active Comparator group

Description:

Usual care according to current guidelines

Treatment:

Behavioral: Usual Care