Enhancing Dialysis Adequacy: Effects of Intradialytic Exercise
NCT ID: NCT01481688
Last Updated: 2011-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
14 participants
INTERVENTIONAL
2011-11-30
2012-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control
Routine haemodialysis sessions as per usual
No interventions assigned to this group
Intradialytic exercise
One hour of exercise completed during haemodialysis.
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
30 minutes extra dialysis time.
Extra time
An extra 30 minutes will be added to the currently prescribed treatment time of each patient.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Receiving maintenance haemodialysis for \> 3 months
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Betsi Cadwaladr University Health Board
OTHER_GOV
B.Braun Avitum AG
INDUSTRY
Bangor University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jamie H Macdonald, PhD
Role: STUDY_DIRECTOR
Bangor University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Renal unit, Ysbyty Gwynedd, Betsi Cadwaladr University Health Board
Bangor, Gwynedd, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Kirkman 11/WA/0112
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
11/WA/0112
Identifier Type: -
Identifier Source: org_study_id