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

University Hospital Bonn (UKB)

Status: Completed

Conditions: End Stage Renal Failure on Dialysis

Treatments: Other: Bicycle-Ergometer Training

Study type: Interventional

Funder types: Other

Identifiers

NCT01561118

DFG HO 1272/21-1 (Other Grant/Funding Number)

Uni-Koeln-1137

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 6 to 19 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Bicycle-Ergometer Training Group

Experimental group

Description:

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.

Treatment:

Other: Bicycle-Ergometer Training

Control

Other group

Description:

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).

Treatment:

Other: Bicycle-Ergometer Training