Enhancing Dialysis Adequacy: Effects of Intradialytic Exercise
Primary Purpose
Chronic Kidney Disease
Status
Unknown status
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Exercise
Extra time
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Dialysis adequacy, Urea clearance, Phosphate clearance, Beta 2 microglobulin clearance, Intradialytic exercise, Haemodialysis patients
Eligibility 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
Sites / Locations
- Renal unit, Ysbyty Gwynedd, Betsi Cadwaladr University Health BoardRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Active Comparator
Arm Label
Control
Intradialytic exercise
Extra time
Arm Description
Routine haemodialysis sessions as per usual
One hour of exercise completed during haemodialysis.
30 minutes extra dialysis time.
Outcomes
Primary Outcome Measures
Urea clearance
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
Urea clearance which will be measured by continuously sampling UV absorbance of waste dialysate during an entire dialysis session.
Full Information
NCT ID
NCT01481688
First Posted
November 24, 2011
Last Updated
November 28, 2011
Sponsor
Bangor University
Collaborators
Betsi Cadwaladr University Health Board, B.Braun Avitum AG
1. Study Identification
Unique Protocol Identification Number
NCT01481688
Brief Title
Enhancing Dialysis Adequacy: Effects of Intradialytic Exercise
Official Title
Intradialytic Exercise for Enhanced Dialysis Adequacy and Solute Removal in Chronic Kidney Disease Patients: A Randomised Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
January 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bangor University
Collaborators
Betsi Cadwaladr University Health Board, B.Braun Avitum AG
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Dialysis adequacy, Urea clearance, Phosphate clearance, Beta 2 microglobulin clearance, Intradialytic exercise, Haemodialysis patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
14 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Routine haemodialysis sessions as per usual
Arm Title
Intradialytic exercise
Arm Type
Experimental
Arm Description
One hour of exercise completed during haemodialysis.
Arm Title
Extra time
Arm Type
Active Comparator
Arm Description
30 minutes extra dialysis time.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Extra time
Intervention Description
An extra 30 minutes will be added to the currently prescribed treatment time of each patient.
Primary Outcome Measure Information:
Title
Urea clearance
Description
The primary outcome is urea clearance which will be measured by continuously sampling waste dialysate from an entire dialysis session.
Time Frame
One dialysis session
Secondary Outcome Measure Information:
Title
Urea clearance
Description
Urea clearance which will be measured by continuously sampling UV absorbance of waste dialysate during an entire dialysis session.
Time Frame
One dialysis session
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jamie H Macdonald, PhD
Phone
0044 1248 383272
Email
j.h.macdonald@bangor.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamie H Macdonald, PhD
Organizational Affiliation
Bangor University
Official's Role
Study Director
Facility Information:
Facility Name
Renal unit, Ysbyty Gwynedd, Betsi Cadwaladr University Health Board
City
Bangor
State/Province
Gwynedd
ZIP/Postal Code
LL57 2PW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danielle Kirkman, MSc
12. IPD Sharing Statement
Citations:
PubMed Identifier
35018639
Citation
Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.
Results Reference
derived
Learn more about this trial
Enhancing Dialysis Adequacy: Effects of Intradialytic Exercise
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