Clinical trial NCT01674153: Investigating the Effects of Exercise on Physiological Changes and Toxin Removal in Hemodialysis Patients
Official title: A Multi Protocol Investigation to Compare the Effects of Intra-dialytic Exercise on Physiological Changes and Toxin Removal in Maintenance Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Dialysis
Keywords: Intra-dialytic exercise
Toxin removal
Hemodiafiltration
Inter-compartmental resistance
Cardiac output
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
Collaborators: name: National University of Singapore
First posted: 2012-08-28
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Hemodialysis is a life-saving treatment for end stage renal disease patients. The chief aims of hemodialysis are solute and fluid removal. Solute removal is associated with outcome of dialysis patients. Intra-dialytic exercise has been found to improve the toxin removal and it is suggested that exercise increases the cardiac output, thus increases the blood flow to lower extremities. This leads to increased toxin removal from low blood flow regions. On the other hand, exercise can possibly dilate the vasculature and decrease the compartmental resistance. In this study, the investigators aim to investigate the exercise induced physiological changes which enhances the toxin removal. This information combined with patient specific mathematical models will encourage clinicians to opt for Optimal intra-dialytic exercise protocol. On the other hand, Hemodiafiltration is widely accepted renal replacement therapy for improved toxin removal. Hence, we intend to compare the toxin removal outcome for standalone Hemodiafiltration and intra-dialytic exercise in conventional hemodialysis.


Eligibility criteria: Inclusion Criteria:

* Adult patients male or female (Age \> 21 years)
* Minimum dialysis vintage of 6 months
* Stable on hemodialysis
* Minimum Hemoglobin level of 10 g/dL
* Blood access capable of delivering the blood flow rate greater than 250 mL/min
* Preserved left ventricular ejection fraction (\>50%) on prior imaging study
* Able to complete a 6min-walk-test without abnormal physiological response, excessive fatigue, or musculoskeletal discomfort

Exclusion Criteria:

* History of recurring or persistent hypotension in past 3 months
* Pregnant woman
* Severely Hypertensive patients (SBP \> 180 mmHg and/or DBP \> 115 mmHg)
* History of recent myocardial infarction or unstable angina (within past 6 months)
* Significant valvular disease, i.e. severe aortic stenosis and moderate-severe mitral regurgitation.
* Patients with end stage organ disease e.g. COPD, recent or debilitating CVA
* Patient with recent stroke (within past 6 months)
* Anemic patients
* History of known arrhythmia
* Participation in another clinical intervention trial
* Moderate to severe osteoarthritis of knee(s)
* Unable to consent

Primary outcomes:
measure: Quantify toxin removal
timeFrame: 6 months
Secondary outcomes:
measure: Compare exercise regimen with HDF
timeFrame: 6 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Dialysis Center, National University of Singapore
Study officials:
affiliation: National University Hospital, Singapore
name: Titus Lau, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vaithilingam I, Polkinghorne KR, Atkins RC, Kerr PG. Time and exercise improve phosphate removal in hemodialysis patients. Am J Kidney Dis. 2004 Jan;43(1):85-9. doi: 10.1053/j.ajkd.2003.09.016.
citation: Ward RA, Greene T, Hartmann B, Samtleben W. Resistance to intercompartmental mass transfer limits beta2-microglobulin removal by post-dilution hemodiafiltration. Kidney Int. 2006 Apr;69(8):1431-7. doi: 10.1038/sj.ki.5000048.
citation: Maheshwari V, Samavedham L, Rangaiah GP. A regional blood flow model for beta2-microglobulin kinetics and for simulating intra-dialytic exercise effect. Ann Biomed Eng. 2011 Dec;39(12):2879-90. doi: 10.1007/s10439-011-0383-5. Epub 2011 Aug 30.
citation: Parsons TL, Toffelmire EB, King-VanVlack CE. Exercise training during hemodialysis improves dialysis efficacy and physical performance. Arch Phys Med Rehabil. 2006 May;87(5):680-7. doi: 10.1016/j.apmr.2005.12.044.
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.
citation: Maheshwari V, Samavedham L, Rangaiah GP, Loy Y, Ling LH, Sethi S, Leong TL. Comparison of toxin removal outcomes in online hemodiafiltration and intra-dialytic exercise in high-flux hemodialysis: a prospective randomized open-label clinical study protocol. BMC Nephrol. 2012 Nov 23;13:156. doi: 10.1186/1471-2369-13-156.