End Stage Renal Failure on DialysisDiaSportNCT01561118
DiaSport - Endurance-orientated Training Program With Children and Adolescents on Maintenance Hemodialysis
A study testing Bicycle-Ergometer Training in people with End Stage Renal Failure on Dialysis, run by University Hospital, Bonn at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 19 years
- Conditions the study is for
- End Stage Renal Failure on Dialysis
- What is being tested?
- Bicycle-Ergometer Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2012to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Bonn. Department of Pediatric and Adolescent Medicine, Division of Pediatric Nephrology
Bonn, 53113
About this study
Official title: DiaSport - Ausdauerorientiertes Trainingsprogramm Mit Kindern Und Jugendlichen an Der Dialyse (DiaSport - Endurance-orientated Training Program With Children and Adolescents on Maintenance Hemodialysis)
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
- Being tested
- Bicycle-Ergometer Training
- Keywords
- hemodialysis, dialysis efficacy, cardiorespiratory capacity, exercise capacity, children and adolescents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bicycle-Ergometer TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: Bicycle-Ergometer Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (8)
Change of the possible workload (maximum physical performance) achieved
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.
Measured: 12 and 24 weeks
Quality of Life
For quality of life assessment the validated and standardized PedsQL® questionnaires will be filled in by patients and parents.
Measured: 12 and 24 weeks
Change of solute removal during hemodialysis
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.
Measured: 12 and 24 weeks
Change of solute removal in the two compartment model (assessed in a subgroup of patients)
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.
Measured: 12 and 24 weeks
Inflammation, nutritional status and bone metabolism
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.
Measured: 12 and 24 weeks
Body Composition Monitoring (BCM)
Body Cpomposition Monitoring (BCM) will be performed to exermine further information on nutrional status, overhydration and muscle growth.
Measured: 12 and 24 weeks
Change of number and dose of medication needed
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).
Measured: 12 and 24 weeks
Telomere length and Telomerase activity
Telomere length and telomerase activity [units] will be used as markers for cell survival, which may be influenced by endurance training.
Measured: 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2012 (estimated)
- Study startSep 2012
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal Failure on DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Collaborators
- German Sport University, Cologne
- Responsible party
- Principal investigator, Prof. Dr. B. Hoppe, University of Bonn
- Investigators
- Bernd Hoppe, MD, Study chair, University Hospital of BonnBettina Schaar, PhD, Study chair, German Sport University, Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01561118
- Sponsor's protocol ID
- Uni-Koeln-1137
- Other IDs
- DFG HO 1272/21-1
- Acronym
- DiaSport
- Status last verified
- Nov 2017
- First submitted
- 20 Mar 2012
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21378148Hoppe 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.
PubMed 22353206Feldkotter 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.
PubMed 34117528
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DiaSport - Ausdauerorientiertes Trainingsprogramm Mit Kindern Und Jugendlichen an Der Dialyse (DiaSport - Endurance-orientated Training Program With Children and Adolescents on Maintenance Hemodialysis)
- ClinicalTrials.gov ID
- NCT01561118
- Acronym / sponsor ID
- DiaSport / Uni-Koeln-1137
- Conditions
- End Stage Renal Failure on Dialysis
- Keywords
- hemodialysis, dialysis efficacy, cardiorespiratory capacity, exercise capacity, children and adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Collaborators
- German Sport University, Cologne
- Study start
- Sep 2012
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 22 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bicycle-Ergometer Training Group | Experimental | Other: Bicycle-Ergometer TrainingPerformance 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. |
| Control | Other | Other: Bicycle-Ergometer TrainingNo 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). |
Who may qualify
- Ages
- 6 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bicycle-Ergometer TrainingPerformance 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. | Other | Bicycle-Ergometer Training Group, Control |
Primary outcome
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
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.
8 secondary outcomes
Change of the possible workload (maximum physical performance) achieved
Time frame: 12 and 24 weeks
Quality of Life
Time frame: 12 and 24 weeks
Change of solute removal during hemodialysis
Time frame: 12 and 24 weeks
Change of solute removal in the two compartment model (assessed in a subgroup of patients)
Time frame: 12 and 24 weeks
Inflammation, nutritional status and bone metabolism
Time frame: 12 and 24 weeks
Body Composition Monitoring (BCM)
Time frame: 12 and 24 weeks
Change of number and dose of medication needed
Time frame: 12 and 24 weeks
Telomere length and Telomerase activity
Time frame: 12 and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
- Background: PubMed 21378148Schaar 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.
- Background: PubMed 22353206Hoppe 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.
- Derived from this study: PubMed 34117528Feldkotter 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernd Hoppe, MD study chair
University Hospital of Bonn
Bettina Schaar, PhD study chair
German Sport University, Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bicycle-Ergometer Training in people with End Stage Renal Failure on Dialysis, run by University Hospital, Bonn at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01561118, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2017.