Investigating the Effects of Exercise on Physiological Changes and Toxin Removal in Hemodialysis Patients
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Multi Protocol Investigation to Compare the Effects of Intra-dialytic Exercise on Physiological Changes and Toxin Removal in Maintenance Hemodialysis Patients|
- Quantify toxin removal [ Time Frame: 6 months ] [ Designated as safety issue: No ]Measure/estimate amount of toxin(s) removed and quantify corresponding physiological changes
- Compare exercise regimen with HDF [ Time Frame: 6 months ] [ Designated as safety issue: No ]Compare amount of toxin removed for conventional hemodialysis (HD), HD with intra-dialytic exercise, and hemodiafiltration
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Prescribe intra-dialytic exercise of three bouts in 4 hours dialysis session.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01674153
|Contact: Titus Lau, MD||+65 6772 4388 ext firstname.lastname@example.org|
|Contact: Vaibhav Maheshwari, B.Tech.||+65 9354 email@example.com|
|Dialysis Center, National University of Singapore||Recruiting|
|Singapore, Singapore, 119074|
|Contact: Titus Lau, MD +65 6772 4388 firstname.lastname@example.org|
|Principal Investigator: Titus Lau, MD|
|Principal Investigator:||Titus Lau, MD||National University Hospital, Singapore|