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Chronic Kidney DiseasesDiaTTNCT03885102

Dialysis Training Therapy: The DiaTT Trial

A study testing Intradialytic exercise intervention in people with Chronic Kidney Diseases and Hemodialysis, run by Prof. Dr. med. Martin Halle at 21 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Kidney Diseases, Hemodialysis
What is being tested?
Intradialytic exercise intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,211 participants
Where
21 sitesGermany
Study dates
1 Apr 2019to 28 Feb 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

21 sites in 1 country.

21 sites in 1 country

Germany21 sites

  • KfH-Nierenzentrum

    Aachen, Northrhine, 52074

  • KfH-Nierenzentrum

    Amberg, Bavaria, 92224

  • KfH-Nierenzentrum

    Aschaffenburg, Bavaria, 63741

  • KfH-Nierenzentrum

    Bamberg, Bavaria, 96050

  • KfH-Nierenzentrum

    Bergisch Gladbach, Northrhine, 51465

  • KfH-Nierenzentrum

    Bochum, Westphalia, 44807

  • KfH-Nierenzentrum

    Coburg, Bavaria, 96450

  • KfH-Nierenzentrum

    Cologne, Northrhine, 51149

  • KfH-Nierenzentrum

    Dachau, Bavaria, 85221

  • KfH-Nierenzentrum

    Ebersberg, Bavaria, 85560

  • KfH-Nierenzentrum

    Freising, Bavaria, 85354

  • KfH-Nierenzentrum

    Fürstenzell, Bavaria, 94081

  • KfH-Nierenzentrum

    Fürth, Bavaria, 90766

  • KfH-Nierenzentrum

    Hagen, Westphalia, 58095

  • KfH-Nierenzentrum

    Halle, Saxony-Anhalt, 06120

  • KfH-Nierenzentrum

    Jena, Thuringia, 07745

  • KfH-Nierenzentrum

    Magdeburg, Saxony-Anhalt, 39112

  • KfH-Nierenzentrum

    Marl, Westphalia, 45768

  • KfH-Nierenzentrum

    München, Bavaria, 80804

  • KfH-Nierenzentrum

    Sonneberg, Thuringia, 96515

  • KfH-Nierenzentrum

    Straubing, Bavaria, 94315

Other trials in Germany

About this study

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

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).

Read the 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.

Being tested
Intradialytic exercise intervention, Usual Care
Keywords
chronic kidney disease, hemodialysis, intradialytic exercise, physical activity, safety, health economics, health literacy, training therapy
Medical subject headings
Renal Insufficiency, Chronic, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intradialytic exercise interventionBehavioural

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

  • Usual CareBehavioural

    Usual care with no exercise intervention or health literacy counselling

Study groups in NCT03885102
Study groupRoleWhat they receive
InterventionExperimental12 months intradialytic exercise intervention
Receives: Behavioral: Intradialytic exercise intervention
Usual careActive comparatorUsual care according to current guidelines
Receives: Behavioral: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sit-to-stand test (STS60)

    Change of Sit-to-stand test (STS 60) (number of repetitions in 60 seconds)

    Measured: between baseline and 12 months

Secondary outcomes (22)

  1. 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).

    Measured: 12 months

  2. 3-point MACE

    a composite of cardiovascular death, non-fatal stroke, or non-fatal myocardial infarction

    Measured: 12 months

  3. sudden death

    Patients alive will be considered as censored observations, and death from other causes will be considered as a competing event

    Measured: 12 months

  4. Sit-to-stand test (STS60)

    measured in number of repetitions in 60 seconds

    Measured: 3, 6 and 9 months

  5. Timed-up-and-go test (TUG)

    measured in time (seconds)

    Measured: 3, 6, 9, and 12 months

  6. Six-Minutes-Walk test (6MWT)

    measured in distance (meter)

    Measured: 3, 6, 9, and 12 months

  7. Grip strength test (GST)

    measured in kilogram

    Measured: 3, 6, 9, and 12 months

  8. hospitalizations

    measured in number and days of hospitalization for comorbidities

    Measured: 12 months

  9. frailty by Multidimensional Prognostic Index (MPI)

    measured in change of scale in questionnaire

    Measured: 3,6 and 12 months

  10. Serum phosphate

    measured in mmol/L

    Measured: 3, 6, 9 and 12 months

  11. Erythropoietin dose

    measured in IE/week

    Measured: 3, 6, 9, and 12 months

  12. Quality of life by SF-36

    measured in change of scale by questionnaire

    Measured: 3, 6 and 12 months

  13. Health literacy by HLS-EU-Q16

    measured in change of scale in questionnaire

    Measured: 3, 6 and 12 months

  14. health economics by medication

    measured in total costs between between study arms

    Measured: 12 months

  15. health economics by hospitalization

    measured in days in hospital between between study arms

    Measured: 12 months

  16. health economics by transportation

    measured in total costs between between study arms

    Measured: 12 months

  17. health economics by medical assistance tools

    measured in total costs between between study arms

    Measured: 12 months

  18. health economics by nursing

    measured in total costs between between study arms

    Measured: 12 months

  19. health economics by sick leave from workplace

    measured in days between between study arms

    Measured: 12 months

  20. needle dislocation/ catheter disconnection

    number of dialysis needle dislocation/ dialysis catheter disconnection

    Measured: 12 months

  21. symptomatic hypotensive episodes

    number of symptomatic hypotensive episodes

    Measured: 12 months

  22. cramps

    number of cramps

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2019
  2. Study start1 Apr 2019
  3. Primary completion28 Feb 2022
  4. Study completion28 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
1,211 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03885102
Sponsor's protocol ID
509/18S-KK
Acronym
DiaTT
Status last verified
Nov 2022
First submitted
18 Mar 2019
Last updated
2 Dec 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • von Gersdorff G, von Korn P, Duvinage A, Ihorst G, Josef A, Kaufmann M, Baer T, Fellerhoff T, Fuhrmann I, Koesel E, Zeissler S, Bobka L, Heinrich M, Schindler A, Weber R, Breuer C, Meyer AM, Polidori MC, Dinges SMT, Schoenfeld J, Siebenbuerger M, Degenhardt S, Anding-Rost K, Halle M. Cluster Randomized Controlled Trial on the Effects of 12 Months of Combined Exercise Training during Hemodialysis in Patients with Chronic Kidney Disease-Study Protocol of the Dialysis Training Therapy (DiaTT) Trial. Methods Protoc. 2021 Aug 31;4(3):60. doi: 10.3390/mps4030060.

    PubMed 34564306

  • Anding-Rost K, von Gersdorff G, von Korn P, Ihorst G, Josef A, Kaufmann M, Huber M, Bar T, Zeissler S, Hofling S, Breuer C, Gartner N, Haykowsky MJ, Degenhardt S, Wanner C, Halle M. Exercise during Hemodialysis in Patients with Chronic Kidney Failure. NEJM Evid. 2023 Sep;2(9):EVIDoa2300057. doi: 10.1056/EVIDoa2300057. Epub 2023 Jun 17.

    PubMed 38320198

Questions about this trial

What is this clinical trial studying?

A study testing Intradialytic exercise intervention in people with Chronic Kidney Diseases and Hemodialysis, run by Prof. Dr. med. Martin Halle at 21 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sit-to-stand test (STS60) (time frame: between baseline and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03885102, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2022.

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