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

NCT01561118 | Completed DMC

• 2 other identifiers: Uni-Koeln-1137DFG HO 1272/21-1
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Failure on Dialysis

Keywords

hemodialysis; dialysis efficacy; cardiorespiratory capacity; exercise capacity; children and adolescents

Outcome Measures

Primary Outcomes (1)

• 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)

  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.

  12 weeks

Secondary Outcomes (8)

• Change of the possible workload (maximum physical performance) achieved

  12 and 24 weeks

• Quality of Life

  12 and 24 weeks

• Change of solute removal during hemodialysis

  12 and 24 weeks

• Change of solute removal in the two compartment model (assessed in a subgroup of patients)

  12 and 24 weeks

• Inflammation, nutritional status and bone metabolism

  12 and 24 weeks

Study Arms (2)

Bicycle-Ergometer Training Group

EXPERIMENTAL

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

Control

OTHER

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

Interventions

Bicycle-Ergometer Training OTHER

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.

Bicycle-Ergometer Training Group; Control

Eligibility Criteria

• Age: 6 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• single pool Kt/V according to Dialysestandard 2006 \> 1.2
• Informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bonn: lead
• German Sport University, Cologne: collaborator

Study Sites (1)

University Hospital Bonn. Department of Pediatric and Adolescent Medicine, Division of Pediatric Nephrology

Bonn, 53113, Germany

Location

Related Publications (3)

• 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.

  PMID: 21378148 BACKGROUND

• 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.

  PMID: 22353206 BACKGROUND

• 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.

  PMID: 34117528 DERIVED

Study Officials

• Bernd Hoppe, MD

  University Hospital of Bonn

  STUDY CHAIR

• Bettina Schaar, PhD

  German Sport University, Cologne

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: March 20, 2012
• First Posted: March 22, 2012
• Study Start: September 1, 2012
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: November 7, 2017

Record last verified: 2017-11

Locations

DE (1)