Investigating the Effects of Exercise on Physiological Changes and Toxin Removal in Hemodialysis Patients

NCT ID: NCT01674153

Last Updated: 2014-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Renal Dialysis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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HD-Exercise-HDF

Prescribe intra-dialytic exercise of three bouts in 4 hours dialysis session.

Group Type EXPERIMENTAL

Intra-dialytic exercise

Intervention Type PROCEDURE

Perform intra-dialytic exercise of three bouts in 4 hours dialysis session. Each patient will perform exercise on Monark 881E rehab trainer (widely used in routine dialysis settings). The exercise intensity will be prescribed based on achievement of 50% of maximum heart rate for each recruited subject.

Interventions

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Intra-dialytic exercise

Perform intra-dialytic exercise of three bouts in 4 hours dialysis session. Each patient will perform exercise on Monark 881E rehab trainer (widely used in routine dialysis settings). The exercise intensity will be prescribed based on achievement of 50% of maximum heart rate for each recruited subject.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National University of Singapore

OTHER

Sponsor Role collaborator

National University Hospital, Singapore

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Titus Lau, MD

Role: PRINCIPAL_INVESTIGATOR

National University Hospital, Singapore

Locations

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Dialysis Center, National University of Singapore

Singapore, , Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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Titus Lau, MD

Role: CONTACT

+65 6772 4388 ext. 4388

Vaibhav Maheshwari, B.Tech.

Role: CONTACT

+65 9354 1493

Facility Contacts

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Titus Lau, MD

Role: primary

+65 6772 4388

References

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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.

Reference Type BACKGROUND
PMID: 14712431 (View on PubMed)

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.

Reference Type RESULT
PMID: 16395268 (View on PubMed)

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.

Reference Type RESULT
PMID: 21877220 (View on PubMed)

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.

Reference Type RESULT
PMID: 16635631 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35018639 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23176731 (View on PubMed)

Other Identifiers

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NKFRC/2011/01/06

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

DSRB - 2011/01942

Identifier Type: -

Identifier Source: org_study_id

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