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

N

National University Health System (NUHS)

Status

Unknown

Conditions

Renal Dialysis

Treatments

Procedure: Intra-dialytic exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT01674153
NKFRC/2011/01/06 (Other Grant/Funding Number)
DSRB - 2011/01942

Details and patient eligibility

About

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.

Enrollment

15 estimated patients

Sex

All

Ages

21 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 1 patient group

HD-Exercise-HDF
Experimental group
Description:
Prescribe intra-dialytic exercise of three bouts in 4 hours dialysis session.
Treatment:
Procedure: Intra-dialytic exercise

Trial contacts and locations

1

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Central trial contact

Titus Lau, MD; Vaibhav Maheshwari, B.Tech.

Data sourced from clinicaltrials.gov

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