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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01674153
Enrollment
15
Registered
2012-08-28
Start date
2012-08-31
Completion date
2014-07-31
Last updated
2014-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Dialysis

Keywords

Intra-dialytic exercise, Toxin removal, Hemodiafiltration, Inter-compartmental resistance, Cardiac output

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.

Interventions

PROCEDUREIntra-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.

Sponsors

National University of Singapore
CollaboratorOTHER
National University Hospital, Singapore
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quantify toxin removal6 monthsMeasure/estimate amount of toxin(s) removed and quantify corresponding physiological changes

Secondary

MeasureTime frameDescription
Compare exercise regimen with HDF6 monthsCompare amount of toxin removed for conventional hemodialysis (HD), HD with intra-dialytic exercise, and hemodiafiltration

Countries

Singapore

Contacts

Primary ContactTitus Lau, MD
titus_lau@nuhs.edu.sg+65 6772 4388
Backup ContactVaibhav Maheshwari, B.Tech.
vmaheshwari@nus.edu.sg+65 9354 1493

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026