Enhancing Dialysis Adequacy: Effects of Intradialytic Exercise

Chronic Kidney Disease Clinical Trial

Official title:

Intradialytic Exercise for Enhanced Dialysis Adequacy and Solute Removal in Chronic Kidney Disease Patients: A Randomised Controlled Trial.

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01481688
• Other study ID #: 11/WA/0112
• Secondary ID: Kirkman 11/WA/01
• Status: Unknown status
• Phase: Phase 4
• First received: November 24, 2011
• Last updated: November 28, 2011
• Start date: November 2011
• Est. completion date: January 2012

Study information

• Verified date: November 2011
• Source: Bangor University
• Contact: Jamie H Macdonald, PhD
• Phone: 0044 1248 383272
• Email: j.h.macdonald[@]bangor.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate whether intradialytic exercise increases removal of waste products from blood, in comparison to the traditional prescription of increasing dialysis duration.

Description:

For patients with severe chronic kidney disease, regular dialysis to remove toxins and waste products from the blood is essential to maintain life. The adequacy of dialysis is quantified by the removal of these toxic solutes and is an important parameter in the assessment of the therapy.

Previous efforts to enhance urea clearance have centered around factors such as increasing dialysis dose by increasing dialysis time or carrying out more frequent dialysis sessions. However this concept is confronted with the barriers of patient compliance and cost implications. Many patients are resilient to increasing their dialysis time, presenting a major challenge for enhancing the efficacy of dialysis therapy. Therefore, alternative methods of improving dialysis adequacy, with interventions aimed at enhancing solute clearance, are highly warranted.

One such intervention could be exercising during haemodialysis (HD). 85% of the body is comprised of lean tissue, of which 73% is water. As many toxic solutes are water based, large amounts will be stored in the muscle. When sitting at rest during HD the blood flow to the muscles is four times less compared to the major organs. Additionally, the HD process causes blood vessels to constrict, further restricting blood flow to the muscle. Consequently there is insufficient blood flow to remove the toxins stored in the muscle. By exercising during dialysis, blood flow to the muscle is increased to sustain the demand for oxygen and energy, thereby allowing toxic solutes to be removed and cleared through the dialysis machine.

Therefore the aim of this study is to implement an efficient exercise intervention during dialysis and determine its effects on dialysis adequacy in comparison to the traditional prescription of increased dialysis time. In particular, the study aims to explore the acute effects of exercise during dialysis on the removal of several established uremic toxins.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 14
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Stage 5 Chronic Kidney Disease

• Receiving maintenance haemodialysis for > 3 months

Exclusion Criteria:

• Unable to give consent

• Present with contraindications to take part in exercise

• Haemoglobin <11 g/dL

• Access recirculation

• Chronic persistent hypotension with pre dialysis systolic blood pressures <100mgHg.

• Episodic treatment induced hypotension with frequent drops in intradialytic systolic blood pressure >30mmgHg

• Unstable medical condition

• Currently taking medication affecting urea or creatinine generation

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• Exercise
Exercise During Dialysis Patients will be asked to carry out cycling exercise for 60 minutes during the third quarter of their routine haemodialysis session. Exercise can be carried out in ten minute bouts with several minutes rest between bouts.
• Extra time
An extra 30 minutes will be added to the currently prescribed treatment time of each patient.

Locations

Country	Name	City	State
United Kingdom	Renal unit, Ysbyty Gwynedd, Betsi Cadwaladr University Health Board	Bangor	Gwynedd

Sponsors (3)

Lead Sponsor	Collaborator
Bangor University	B.Braun Avitum AG, Betsi Cadwaladr University Health Board

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urea clearance	The primary outcome is urea clearance which will be measured by continuously sampling waste dialysate from an entire dialysis session.	One dialysis session
Secondary	Urea clearance	Urea clearance which will be measured by continuously sampling UV absorbance of waste dialysate during an entire dialysis session.	One dialysis session

External Links

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