Renal DialysisNCT01674153
Investigating the Effects of Exercise on Physiological Changes and Toxin Removal in Hemodialysis Patients
A study testing Intra-dialytic exercise in people with Renal Dialysis, run by National University Hospital, Singapore at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Renal Dialysis
- What is being tested?
- Intra-dialytic exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSingapore
- Study dates
- Aug 2012to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Dialysis Center, National University of Singapore
Singapore, 119074
Titus Lau, MD, +65 6772 4388, titus_lau@nuhs.edu.sg
Titus Lau, MD
About this study
Official title: A Multi Protocol Investigation to Compare the Effects of Intra-dialytic Exercise on Physiological Changes and Toxin Removal in Maintenance 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.
- Conditions
- Renal Dialysis
- Being tested
- Intra-dialytic exercise
- Keywords
- Intra-dialytic exercise, Toxin removal, Hemodiafiltration, Inter-compartmental resistance, Cardiac output
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-dialytic exerciseProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| HD-Exercise-HDF | Experimental | Prescribe intra-dialytic exercise of three bouts in 4 hours dialysis session. Receives: Procedure: Intra-dialytic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantify toxin removal
Measure/estimate amount of toxin(s) removed and quantify corresponding physiological changes
Measured: 6 months
Secondary outcomes (1)
Compare exercise regimen with HDF
Compare amount of toxin removed for conventional hemodialysis (HD), HD with intra-dialytic exercise, and hemodiafiltration
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionApr 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Renal DialysisStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Singapore
- Responsible party
- Sponsor
- Investigators
- Titus Lau, MD, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01674153
- Sponsor's protocol ID
- DSRB - 2011/01942
- Other IDs
- NKFRC/2011/01/06
- Status last verified
- Apr 2014
- First submitted
- 23 Aug 2012
- Last updated
- 3 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 14712431Ward 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.
PubMed 16395268Maheshwari 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.
PubMed 21877220Parsons 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.
PubMed 16635631Bernier-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.
PubMed 35018639Maheshwari 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.
PubMed 23176731
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi Protocol Investigation to Compare the Effects of Intra-dialytic Exercise on Physiological Changes and Toxin Removal in Maintenance Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT01674153
- Acronym / sponsor ID
- DSRB - 2011/01942
- Conditions
- Renal Dialysis
- Keywords
- Intra-dialytic exercise, Toxin removal, Hemodiafiltration, Inter-compartmental resistance, Cardiac output
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- National University of Singapore
- Study start
- Aug 2012
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 28 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HD-Exercise-HDF | Experimental | Procedure: Intra-dialytic exercisePrescribe intra-dialytic exercise of three bouts in 4 hours dialysis session. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-dialytic exercisePerform 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. | Procedure or surgery | HD-Exercise-HDF |
Primary outcome
Quantify toxin removal
Time frame: 6 months
Measure/estimate amount of toxin(s) removed and quantify corresponding physiological changes
1 secondary outcome
Compare exercise regimen with HDF
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2014.
- Background: PubMed 14712431Vaithilingam 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.
- Results publication: PubMed 16395268Ward 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.
- Results publication: PubMed 21877220Maheshwari 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.
- Results publication: PubMed 16635631Parsons 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.
- Derived from this study: PubMed 35018639Bernier-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.
- Derived from this study: PubMed 23176731Maheshwari 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Titus Lau, MD principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-dialytic exercise in people with Renal Dialysis, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Titus Lau, MD (+65 6772 4388 ext. 4388, titus_lau@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantify toxin removal (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01674153, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2014.