Enhancing Dialysis Adequacy: Effects of Intradialytic Exercise
Recruitment status was Recruiting
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Intradialytic Exercise for Enhanced Dialysis Adequacy and Solute Removal in Chronic Kidney Disease Patients: A Randomised Controlled Trial.|
- Urea clearance [ Time Frame: One dialysis session ] [ Designated as safety issue: No ]The primary outcome is urea clearance which will be measured by continuously sampling waste dialysate from an entire dialysis session.
- Urea clearance [ Time Frame: One dialysis session ] [ Designated as safety issue: No ]Urea clearance which will be measured by continuously sampling UV absorbance of waste dialysate during an entire dialysis session.
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||January 2012|
|Estimated Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
No Intervention: Control
Routine haemodialysis sessions as per usual
Experimental: Intradialytic exercise
One hour of exercise completed during haemodialysis.
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.
Active Comparator: Extra time
30 minutes extra dialysis time.
Other: Extra time
An extra 30 minutes will be added to the currently prescribed treatment time of each patient.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01481688
|Contact: Jamie H Macdonald, PhD||0044 1248 firstname.lastname@example.org|
|Renal unit, Ysbyty Gwynedd, Betsi Cadwaladr University Health Board||Recruiting|
|Bangor, Gwynedd, United Kingdom, LL57 2PW|
|Principal Investigator: Danielle Kirkman, MSc|
|Study Director:||Jamie H Macdonald, PhD||Bangor University|