Dialysis Training Therapy: The DiaTT Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1211 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2022-02-28

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).

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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.

Conditions

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Chronic Kidney Diseases Hemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

12 months intradialytic exercise intervention

Group Type EXPERIMENTAL

Intradialytic exercise intervention

Intervention Type BEHAVIORAL

50% aerobic exercise, 50% resistance training thrice a week for 60 min per dialysis session, and health literacy counselling

Usual care

Usual care according to current guidelines

Group Type ACTIVE_COMPARATOR

Usual Care

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No