Clinical trial NCT01561118: DiaSport - Endurance-orientated Training Program With Children and Adolescents on Maintenance Hemodialysis
Official title: DiaSport - Ausdauerorientiertes Trainingsprogramm Mit Kindern Und Jugendlichen an Der Dialyse (DiaSport - Endurance-orientated Training Program With Children and Adolescents on Maintenance Hemodialysis)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Failure on Dialysis
Keywords: hemodialysis
dialysis efficacy
cardiorespiratory capacity
exercise capacity
children and adolescents
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
Collaborators: name: German Sport University, Cologne
First posted: 2012-03-22
Enrollment: 66
Sex: ALL
Minimum age (years): 6
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: 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)
timeFrame: 12 weeks
Secondary outcomes:
measure: Change of the possible workload (maximum physical performance) achieved
timeFrame: 12 and 24 weeks
measure: Quality of Life
timeFrame: 12 and 24 weeks
measure: Change of solute removal during hemodialysis
timeFrame: 12 and 24 weeks
measure: Change of solute removal in the two compartment model (assessed in a subgroup of patients)
timeFrame: 12 and 24 weeks
measure: Inflammation, nutritional status and bone metabolism
timeFrame: 12 and 24 weeks
measure: Body Composition Monitoring (BCM)
timeFrame: 12 and 24 weeks
measure: Change of number and dose of medication needed
timeFrame: 12 and 24 weeks
measure: Telomere length and Telomerase activity
timeFrame: 12 and 24 weeks
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University Hospital Bonn. Department of Pediatric and Adolescent Medicine, Division of Pediatric Nephrology
Study officials:
affiliation: University Hospital of Bonn
name: Bernd Hoppe, MD
role: STUDY_CHAIR
affiliation: German Sport University, Cologne
name: Bettina Schaar, PhD
role: STUDY_CHAIR
References:
citation: Schaar B, Feldkotter M, Nonn JM, Hoppe B. Cardiorespiratory capacity in children and adolescents on maintenance haemodialysis. Nephrol Dial Transplant. 2011 Nov;26(11):3701-8. doi: 10.1093/ndt/gfr014. Epub 2011 Mar 4.
citation: Hoppe B, Schaar B. The impact of nutrition and physical activity on long-term survival after pediatric solid organ transplantation. Pediatr Transplant. 2012 Nov;16(7):675-7. doi: 10.1111/j.1399-3046.2012.01663.x. Epub 2012 Feb 21. No abstract available.
citation: Feldkotter M, Thys S, Adams A, Becker I, Buscher R, Pohl M, Schild R, Pape L, Schmitt CP, Taylan C, Wygoda S, Klaus G, Fehrenbach H, Montoya C, Konrad M, Billing H, Schaar B, Hoppe B. Endurance-oriented training program with children and adolescents on maintenance hemodialysis to enhance dialysis efficacy-DiaSport. Pediatr Nephrol. 2021 Dec;36(12):3923-3932. doi: 10.1007/s00467-021-05114-8. Epub 2021 Jun 12.