Enhancing Dialysis Adequacy: Effects of Intradialytic Exercise

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Bangor University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Betsi Cadwaladr University Health Board
B.Braun Avitum AG
Information provided by (Responsible Party):
Bangor University
ClinicalTrials.gov Identifier:
NCT01481688
First received: November 24, 2011
Last updated: November 28, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Chronic Kidney Disease
Other: Exercise
Other: Extra time
Phase 4

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by Bangor University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 14
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)
Arms Assigned Interventions
No Intervention: Control
Routine haemodialysis sessions as per usual
Experimental: Intradialytic exercise
One hour of exercise completed during haemodialysis.
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.
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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01481688

Contacts
Contact: Jamie H Macdonald, PhD 0044 1248 383272 j.h.macdonald@bangor.ac.uk

Locations
United Kingdom
Renal unit, Ysbyty Gwynedd, Betsi Cadwaladr University Health Board Recruiting
Bangor, Gwynedd, United Kingdom, LL57 2PW
Principal Investigator: Danielle Kirkman, MSc         
Sponsors and Collaborators
Bangor University
Betsi Cadwaladr University Health Board
B.Braun Avitum AG
Investigators
Study Director: Jamie H Macdonald, PhD Bangor University
  More Information

Additional Information:
No publications provided

Responsible Party: Bangor University
ClinicalTrials.gov Identifier: NCT01481688     History of Changes
Other Study ID Numbers: 11/WA/0112, Kirkman 11/WA/0112
Study First Received: November 24, 2011
Last Updated: November 28, 2011
Health Authority: United Kingdom: National Health Service

Keywords provided by Bangor University:
Dialysis adequacy
Urea clearance
Phosphate clearance
Beta 2 microglobulin clearance
Intradialytic exercise
Haemodialysis patients

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on September 16, 2014