NCT01674153

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

April 3, 2014

Status Verified

April 1, 2014

Enrollment Period

1.7 years

First QC Date

August 23, 2012

Last Update Submit

April 1, 2014

Conditions

Renal Dialysis

Keywords

Intra-dialytic exerciseToxin removalHemodiafiltrationInter-compartmental resistanceCardiac output

Outcome Measures

Primary Outcomes (1)

  • Quantify toxin removal

    Measure/estimate amount of toxin(s) removed and quantify corresponding physiological changes

    6 months

Secondary Outcomes (1)

  • Compare exercise regimen with HDF

    6 months

Study Arms (1)

HD-Exercise-HDF

EXPERIMENTAL

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

Procedure: Intra-dialytic exercise

Interventions

Intra-dialytic exercisePROCEDURE

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.

HD-Exercise-HDF

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dialysis Center, National University of Singapore

Singapore, 119074, Singapore

RECRUITING

Related Publications (6)

  • 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.

    PMID: 14712431BACKGROUND

  • 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.

    PMID: 16395268RESULT

  • 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.

    PMID: 21877220RESULT

  • 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.

    PMID: 16635631RESULT

  • 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.

    PMID: 35018639DERIVED

  • 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.

    PMID: 23176731DERIVED

Study Officials

  • Titus Lau, MD

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Titus Lau, MD

CONTACT

+65 6772 4388titus_lau@nuhs.edu.sg

Vaibhav Maheshwari, B.Tech.

CONTACT

+65 9354 1493vmaheshwari@nus.edu.sg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2012

First Posted

August 28, 2012

Study Start

August 1, 2012

Primary Completion

April 1, 2014

Study Completion

July 1, 2014

Last Updated

April 3, 2014

Record last verified: 2014-04

Locations

SG(1)