Enhancing Dialysis Adequacy: Effects of Intradialytic Exercise

November 28, 2011 updated by: Bangor University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

14

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
    • Gwynedd
      • Bangor, Gwynedd, United Kingdom, LL57 2PW
        • Recruiting
        • Renal unit, Ysbyty Gwynedd, Betsi Cadwaladr University Health Board
        • Principal Investigator:
          • Danielle Kirkman, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urea clearance
Time Frame: One dialysis session
The primary outcome is urea clearance which will be measured by continuously sampling waste dialysate from an entire dialysis session.
One dialysis session

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urea clearance
Time Frame: One dialysis session
Urea clearance which will be measured by continuously sampling UV absorbance of waste dialysate during an entire dialysis session.
One dialysis session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bangor University

Collaborators

Betsi Cadwaladr University Health Board
B.Braun Avitum AG

Investigators

  • Study Director: Jamie H Macdonald, PhD, Bangor University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Anticipated)

January 1, 2012

Study Completion (Anticipated)

January 1, 2012

Study Registration Dates

First Submitted

November 24, 2011

First Submitted That Met QC Criteria

November 28, 2011

First Posted (Estimate)

November 29, 2011

Study Record Updates

Last Update Posted (Estimate)

November 29, 2011

Last Update Submitted That Met QC Criteria

November 28, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11/WA/0112
  • Kirkman 11/WA/0112 (Other Grant/Funding Number: R & D Reference Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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