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

Renal Dialysis Clinical Trial

Official title:

A Multi Protocol Investigation to Compare the Effects of Intra-dialytic Exercise on Physiological Changes and Toxin Removal in Maintenance Hemodialysis Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01674153
• Other study ID #: DSRB - 2011/01942
• Secondary ID: NKFRC/2011/01/06
• Status: Recruiting
• Phase: N/A
• First received: August 23, 2012
• Last updated: April 1, 2014
• Start date: August 2012
• Est. completion date: July 2014

Study information

• Verified date: April 2014
• Source: National University Hospital, Singapore
• Contact: Titus Lau, MD
• Phone: +65 6772 4388
• Email: titus_lau[@]nuhs.edu.sg
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: July 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Renal Dialysis

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Singapore	Dialysis Center, National University of Singapore	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National University Hospital, Singapore	National University, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (4)

Maheshwari V, Samavedham L, Rangaiah GP. A regional blood flow model for ß2-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. Erratum in: An — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantify toxin removal	Measure/estimate amount of toxin(s) removed and quantify corresponding physiological changes	6 months	No
Secondary	Compare exercise regimen with HDF	Compare amount of toxin removed for conventional hemodialysis (HD), HD with intra-dialytic exercise, and hemodiafiltration	6 months	No