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

NCT ID: NCT01561118

Last Updated: 2017-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2017-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Bicycle-Ergometer Training

Intervention Type: 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.

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).

Group Type: OTHER

Bicycle-Ergometer Training

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Sport University, Cologne

OTHER

Sponsor Role: collaborator

University Hospital, Bonn

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. B. Hoppe

Prof. Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bernd Hoppe, MD

Role: STUDY_CHAIR

University Hospital of Bonn

Bettina Schaar, PhD

Role: STUDY_CHAIR

German Sport University, Cologne

Locations

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

Bonn, , Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 21378148 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22353206 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34117528 (View on PubMed)

Other Identifiers

DFG HO 1272/21-1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Uni-Koeln-1137

Identifier Type: -

Identifier Source: org_study_id