DiaSport - Endurance-orientated Training Program With Children and Adolescents on Maintenance Hemodialysis

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2012 by University of Cologne
Sponsor:
Collaborators:
German Sport University, Cologne
Hannover Medical School
Information provided by (Responsible Party):
Prof. Dr. B. Hoppe, University of Cologne
ClinicalTrials.gov Identifier:
NCT01561118
First received: March 20, 2012
Last updated: March 23, 2012
Last verified: March 2012
  Purpose

Physical activity is considered essential for optimal health, development, socialization and well-being of children. However patients with end-stage renal disease (ESRD) are often restricted from participation in exercise activities. This is especially true for children on hemodialysis (HD). As a consequence their exercise capacity is reduced, both before, but most impressively after HD. In a nationwide randomized, multi-center design this study aims to proof the influence of an individualised endurance training program by bicycle ergometer performed during dialysis on the efficacy of HD, measured as single pool Kt/V. Secondary goals are to enhance physical performance, physical and mental well-being, and to improve measurable blood and treatment parameters (e.g. haemoglobin level, amount of medication). A positive impact of physical activity was observed in adults on HD, although most studies did not address this issue in a randomised protocol. Despite this beneficial evidence in adults, sport is still not integrated as part of standard care in patients on maintenance HD. The study protocol, developed in close collaboration with the German Sport University Cologne, differs substantially from previously published reports as it uses bicycle ergometer training in an upright position outside the dialysis couch and adapts the intensity of intervention to the patient's capabilities. Based on the expected results the investigators will develop an individualised training program to be integrated in the standard care of (pediatric) patients on maintenance HD.


Condition Intervention
End Stage Renal Failure on Dialysis
Other: Bicycle-Ergometer Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: DiaSport - Ausdauerorientiertes Trainingsprogramm Mit Kindern Und Jugendlichen an Der Dialyse (DiaSport - Endurance-orientated Training Program With Children and Adolescents on Maintenance Hemodialysis)

Resource links provided by NLM:


Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • Change of single pool Kt/V (KDOQI Guidelines) - expressed as the change of single pool Kt/V from week 0 to 12 of intervention (period 1) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Change of single pool Kt/V (spKt/V) measured at week 12 (V1) compared to baseline (V0). Single pool Kt/V is the standard measure to assess dialysis efficacy. As dialysis efficacy is the primary aim of dialysis treatment and the spKt/V is the best way to measure efficacy this figure has an important clinical relevance for the patient.


Secondary Outcome Measures:
  • Change of the possible workload (maximum physical performance) achieved [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
    The maximal possible workload will be determined by an exercise evaluation program with increasing power on a leg bicycle ergometer before a hemodialysis session, measuring the peak oxygen uptake (VO2-peak), heart rate, blood pressure and lactate levels during exercise.

  • Quality of Life [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
    For quality of life assessment the validated and standardized PedsQL® questionnaires will be filled in by patients and parents.

  • Change of solute removal during hemodialysis [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: Yes ]
    Solute removal during hemodialysis has a clear impact on the patient's health and well-being, as it reduces sequelae and offers the patient less restrictions on their diet, which would lead to a better compliance.

  • Change of solute removal in the two compartment model (assessed in a subgroup of patients) [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: Yes ]
    Solute removal in the two compartment model will only be analyzed in patients 12 years of age or older with explicit consent to a second blood drawing 30 minutes after end of hemodialysis session. It was previously used showing a significant enhancement during exercise, explained by an increase of skeletal muscles perfusion during exercise.

  • Inflammation, nutritional status and bone metabolism [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
    The nutritional status and bone metabolism will be determined as they are important for optimal health and growth of paediatric hemodialysis patients. Evidence is based on studies that showed trends towards a better nutritional status and less chronic inflammation.

  • Body Composition Monitoring (BCM) [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
    Body Cpomposition Monitoring (BCM) will be performed to exermine further information on nutrional status, overhydration and muscle growth.

  • Change of number and dose of medication needed [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
    Number and dose of medication will be recorded, changes will be evaluated, and data will be correlated to e.g. the measured blood pressure (antihypertensive drugs) or haemoglobin levels (EPO or EPO stimulating agents).

  • Telomere length and Telomerase activity [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
    Telomere length and telomerase activity [units] will be used as markers for cell survival, which may be influenced by endurance training.


Estimated Enrollment: 66
Study Start Date: April 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bicycle-Ergometer Training Group

Performance adapted, hence individualised three times weekly bicycle-ergometer training during hemodialysis. Each training will last 30 to 50 minutes, with 70-80% of the patient specific maximum workload over 12 weeks (36 training sessions).

In the second part of the study intervention will be prolonged for another 12 weeks.

Other: Bicycle-Ergometer Training

Performance adapted, hence individualised three times weekly bicycle-ergometer training during hemodialysis. Each training will last 30 to 50 minutes with 70-80% of the patient specific maximum workload over 12 weeks (36 training sessions - first part of the study compared to no intervention).

In the second part of the study both groups get the opportunity for another 12 weeks of individualised three times weekly bicycle-ergometer training during hemodialysis.

No Intervention: Control

No intervention during hemodialysis during the first 12 weeks of the study.

In the second part of the study a training program, according to that of the intervention group, will be performed with a performance adapted, hence individualised three times weekly bicycle-ergometer training during hemodialysis. Each training will last 30 to 50 minutes, with 70-80% of the patient specific maximum workload over 12 weeks (36 training sessions).

Other: Bicycle-Ergometer Training

Performance adapted, hence individualised three times weekly bicycle-ergometer training during hemodialysis. Each training will last 30 to 50 minutes with 70-80% of the patient specific maximum workload over 12 weeks (36 training sessions - first part of the study compared to no intervention).

In the second part of the study both groups get the opportunity for another 12 weeks of individualised three times weekly bicycle-ergometer training during hemodialysis.


  Eligibility

Ages Eligible for Study:   6 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • End stage renal disease with need of renal replacement therapy
  • children and adolescents aged ≥6 to ≤19 years
  • maintenance hemodialysis for at least 3 months
  • Stable and appropriate dialysis condition in the last 4 weeks before inclusion to the study (basically stable blood and dialysate flow rate and same dialyser)
  • single pool Kt/V according to Dialysestandard 2006 > 1.2
  • Informed consent

Exclusion Criteria:

  • Participation in another interventional clinical trial
  • severe primary neurologic, orthopaedic or cardiac disease, or secondary disease known as a contraindication for endurance training
  • uncontrolled hyper- or hypotension, or cardiac disease
  • Recurrent uncontrolled epileptic seizures
  • dialysis shunt at the lower limbs
  • pregnancy
  • already planned medical intervention, for example living donor kidney transplantation or any other surgery, within the first period of the trial which will cause cancelation of more then 3 training units in a row
  • Subjects who are in dependency to the sponsor or the PI of the trial, or confined to an institution on judicial or official behalf
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01561118

Contacts
Contact: Bernd Hoppe, MD +49-221-478 ext 6831 bernd.hoppe@uk-koeln.de
Contact: Markus Feldkötter, MD +49-221-478 ext 6831 markus.feldkoetter@uk-koeln.de

Locations
Germany
University Hospital Cologne. Department of Pediatric and Adolescent Medicine, Division of Pediatric Nephrology Not yet recruiting
Cologne, Germany, 50924
Contact: Bernd Hoppe, MD    +49-221-478 ext 6831    kindernephrologie@uk-koeln.de   
Contact: Markus Feldkötter, MD    +49-221-478 ext 6831    kindernephrologie@uk-koeln.de   
Principal Investigator: Bernd Hoppe, MD         
Sub-Investigator: Markus Feldkötter, MD         
Sub-Investigator: Bettina Schaar, PhD         
Sponsors and Collaborators
University of Cologne
German Sport University, Cologne
Hannover Medical School
Investigators
Study Chair: Bernd Hoppe, MD University Hospital of Cologne
Study Chair: Bettina Schaar, PD German Sport University, Cologne
  More Information

Additional Information:
Publications:
Responsible Party: Prof. Dr. B. Hoppe, Prof. Dr. med., University of Cologne
ClinicalTrials.gov Identifier: NCT01561118     History of Changes
Other Study ID Numbers: Uni-Koeln-1137, DFG HO 1272/21-1
Study First Received: March 20, 2012
Last Updated: March 23, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by University of Cologne:
hemodialysis
dialysis efficacy
cardiorespiratory capacity
exercise capacity
children and adolescents

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases

ClinicalTrials.gov processed this record on October 20, 2014