Dialysis Training Therapy: The DiaTT Trial

Chronic Kidney Diseases Clinical Trial

— DiaTT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03885102
• Other study ID #: 509/18S-KK
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: February 28, 2022

Study information

• Verified date: November 2022
• Source: Technical University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 counseling (HLC) for 12 months (Intervention group) in comparison to control group (usual care, UC; no ET, no HLC).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1211
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Hemodialysis
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• Intradialytic exercise intervention
50% aerobic exercise, 50% resistance training thrice a week for 60 min per dialysis session, and health literacy counselling
• Usual Care
Usual care with no exercise intervention or health literacy counselling

Locations

Country	Name	City	State
Germany	KfH-Nierenzentrum	Aachen	Northrhine
Germany	KfH-Nierenzentrum	Amberg	Bavaria
Germany	KfH-Nierenzentrum	Aschaffenburg	Bavaria
Germany	KfH-Nierenzentrum	Bamberg	Bavaria
Germany	KfH-Nierenzentrum	Bergisch Gladbach	Northrhine
Germany	KfH-Nierenzentrum	Bochum	Westphalia
Germany	KfH-Nierenzentrum	Coburg	Bavaria
Germany	KfH-Nierenzentrum	Dachau	Bavaria
Germany	KfH-Nierenzentrum	Ebersberg	Bavaria
Germany	KfH-Nierenzentrum	Freising	Bavaria
Germany	KfH-Nierenzentrum	Fürstenzell	Bavaria
Germany	KfH-Nierenzentrum	Fürth	Bavaria
Germany	KfH-Nierenzentrum	Hagen	Westphalia
Germany	KfH-Nierenzentrum	Halle	Saxony-Anhalt
Germany	KfH-Nierenzentrum	Jena	Thuringia
Germany	KfH-Nierenzentrum	Köln	Northrhine
Germany	KfH-Nierenzentrum	Magdeburg	Saxony-Anhalt
Germany	KfH-Nierenzentrum	Marl	Westphalia
Germany	KfH-Nierenzentrum	München	Bavaria
Germany	KfH-Nierenzentrum	Sonneberg	Thuringia
Germany	KfH-Nierenzentrum	Straubing	Bavaria

Sponsors (9)

Lead Sponsor	Collaborator
Prof. Dr. med. Martin Halle	AOK PLUS, BARMER, Clinical Trials Unit Freiburg, Federal Joint Committee, KfH Kuratorium für Dialyse und Nierentransplantation, Technical University of Munich, Techniker Krankenkasse, University Hospital of Cologne

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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, Degenhar — View Citation

Outcome

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