Trial record 1 of 1 for:
diatt
Dialysis Training Therapy: The DiaTT Trial (DiaTT)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03885102 |
|
Recruitment Status :
Completed
First Posted : March 21, 2019
Last Update Posted : December 2, 2022
|
Sponsor:
Prof. Dr. med. Martin Halle
Collaborators:
Technical University of Munich
University Hospital of Cologne
KfH Kuratorium für Dialyse und Nierentransplantation
Clinical Trials Unit Freiburg
AOK PLUS
BARMER
Techniker Krankenkasse
Federal Joint Committee
Information provided by (Responsible Party):
Prof. Dr. med. Martin Halle, Technical University of Munich
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Kidney Diseases Hemodialysis | Behavioral: Intradialytic exercise intervention Behavioral: Usual Care | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1211 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention 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) |
| Primary Purpose: | Treatment |
| Official Title: | Exercise During Hemodialysis: The Dialysis Training Therapy (DiaTT) Trial |
| Actual Study Start Date : | April 1, 2019 |
| Actual Primary Completion Date : | February 28, 2022 |
| Actual Study Completion Date : | February 28, 2022 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Intervention
12 months intradialytic exercise intervention
|
Behavioral: Intradialytic exercise intervention
50% aerobic exercise, 50% resistance training thrice a week for 60 min per dialysis session, and health literacy counselling |
|
Active Comparator: Usual care
Usual care according to current guidelines
|
Behavioral: Usual Care
Usual care with no exercise intervention or health literacy counselling |
Primary Outcome Measures :
- Sit-to-stand test (STS60) [ Time Frame: between baseline and 12 months ]Change of Sit-to-stand test (STS 60) (number of repetitions in 60 seconds)
Secondary Outcome Measures :
- Overall survival [ Time Frame: 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).
- 3-point MACE [ Time Frame: 12 months ]a composite of cardiovascular death, non-fatal stroke, or non-fatal myocardial infarction
- sudden death [ Time Frame: 12 months ]Patients alive will be considered as censored observations, and death from other causes will be considered as a competing event
- Sit-to-stand test (STS60) [ Time Frame: 3, 6 and 9 months ]measured in number of repetitions in 60 seconds
- Timed-up-and-go test (TUG) [ Time Frame: 3, 6, 9, and 12 months ]measured in time (seconds)
- Six-Minutes-Walk test (6MWT) [ Time Frame: 3, 6, 9, and 12 months ]measured in distance (meter)
- Grip strength test (GST) [ Time Frame: 3, 6, 9, and 12 months ]measured in kilogram
- hospitalizations [ Time Frame: 12 months ]measured in number and days of hospitalization for comorbidities
- frailty by Multidimensional Prognostic Index (MPI) [ Time Frame: 3,6 and 12 months ]measured in change of scale in questionnaire
- Serum phosphate [ Time Frame: 3, 6, 9 and 12 months ]measured in mmol/L
- Erythropoietin dose [ Time Frame: 3, 6, 9, and 12 months ]measured in IE/week
- Quality of life by SF-36 [ Time Frame: 3, 6 and 12 months ]measured in change of scale by questionnaire
- Health literacy by HLS-EU-Q16 [ Time Frame: 3, 6 and 12 months ]measured in change of scale in questionnaire
- health economics by medication [ Time Frame: 12 months ]measured in total costs between between study arms
- health economics by hospitalization [ Time Frame: 12 months ]measured in days in hospital between between study arms
- health economics by transportation [ Time Frame: 12 months ]measured in total costs between between study arms
- health economics by medical assistance tools [ Time Frame: 12 months ]measured in total costs between between study arms
- health economics by nursing [ Time Frame: 12 months ]measured in total costs between between study arms
- health economics by sick leave from workplace [ Time Frame: 12 months ]measured in days between between study arms
- needle dislocation/ catheter disconnection [ Time Frame: 12 months ]number of dialysis needle dislocation/ dialysis catheter disconnection
- symptomatic hypotensive episodes [ Time Frame: 12 months ]number of symptomatic hypotensive episodes
- cramps [ Time Frame: 12 months ]number of cramps
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885102
Locations
| Germany | |
| KfH-Nierenzentrum | |
| Amberg, Bavaria, Germany, 92224 | |
| KfH-Nierenzentrum | |
| Aschaffenburg, Bavaria, Germany, 63741 | |
| KfH-Nierenzentrum | |
| Bamberg, Bavaria, Germany, 96050 | |
| KfH-Nierenzentrum | |
| Coburg, Bavaria, Germany, 96450 | |
| KfH-Nierenzentrum | |
| Dachau, Bavaria, Germany, 85221 | |
| KfH-Nierenzentrum | |
| Ebersberg, Bavaria, Germany, 85560 | |
| KfH-Nierenzentrum | |
| Freising, Bavaria, Germany, 85354 | |
| KfH-Nierenzentrum | |
| Fürstenzell, Bavaria, Germany, 94081 | |
| KfH-Nierenzentrum | |
| Fürth, Bavaria, Germany, 90766 | |
| KfH-Nierenzentrum | |
| München, Bavaria, Germany, 80804 | |
| KfH-Nierenzentrum | |
| Straubing, Bavaria, Germany, 94315 | |
| KfH-Nierenzentrum | |
| Aachen, Northrhine, Germany, 52074 | |
| KfH-Nierenzentrum | |
| Bergisch Gladbach, Northrhine, Germany, 51465 | |
| KfH-Nierenzentrum | |
| Köln, Northrhine, Germany, 51149 | |
| KfH-Nierenzentrum | |
| Halle, Saxony-Anhalt, Germany, 06120 | |
| KfH-Nierenzentrum | |
| Magdeburg, Saxony-Anhalt, Germany, 39112 | |
| KfH-Nierenzentrum | |
| Jena, Thuringia, Germany, 07745 | |
| KfH-Nierenzentrum | |
| Sonneberg, Thuringia, Germany, 96515 | |
| KfH-Nierenzentrum | |
| Bochum, Westphalia, Germany, 44807 | |
| KfH-Nierenzentrum | |
| Hagen, Westphalia, Germany, 58095 | |
| KfH-Nierenzentrum | |
| Marl, Westphalia, Germany, 45768 | |
Sponsors and Collaborators
Prof. Dr. med. Martin Halle
Technical University of Munich
University Hospital of Cologne
KfH Kuratorium für Dialyse und Nierentransplantation
Clinical Trials Unit Freiburg
AOK PLUS
BARMER
Techniker Krankenkasse
Federal Joint Committee
Investigators
| Study Chair: | Gabriele Ihorst, PhD | Clinical Trials Unit Freiburg, Medical Center, University of Freiburg | |
| Study Chair: | Gero von Gersdorff, MD | Department II of Internal Medicine, University of Cologne | |
| Study Chair: | Kirsten Anding-Rost, MD | KfH Kuratorium für Dialyse und Nierentransplantation e.V. | |
| Principal Investigator: | Martin Halle, Prof. MD | Department of Prevention, Rehabilitation and Sports medicine, University hospital 'Klinikum rechts der Isar', Technical University of Munich |
Publications of Results:
| Responsible Party: | Prof. Dr. med. Martin Halle, Univ.-Prof. MD, Technical University of Munich |
| ClinicalTrials.gov Identifier: | NCT03885102 |
| Other Study ID Numbers: |
509/18S-KK |
| First Posted: | March 21, 2019 Key Record Dates |
| Last Update Posted: | December 2, 2022 |
| Last Verified: | November 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Prof. Dr. med. Martin Halle, Technical University of Munich:
|
chronic kidney disease hemodialysis intradialytic exercise physical activity |
safety health economics health literacy training therapy |
Additional relevant MeSH terms:
|
Kidney Diseases Renal Insufficiency, Chronic Urologic Diseases Renal Insufficiency |