Chronic Kidney Disease Requiring Chronic DialysisNCT03027778
Intradialytic Pedalling Exercise and Vascular Hemodynamic Parameters Among Prevalent Hemodialysis Population
A study testing Exercise in people with Chronic Kidney Disease Requiring Chronic Dialysis, run by McGill University Health Centre/Research Institute of the McGill University Health Centre.
Trial summary
The purpose of this pilot study is to evaluate 1) the effect of intradialytic pedaling exercise on arterial stiffness and other arterial hemodynamic parameters over 4 months, and 2) the longer-term effect of pedaling on arterial stiffness and other arterial hemodynamic parameters 4 months after finishing the exercise… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease Requiring Chronic Dialysis
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Jan 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with end-stage renal disease (stage 5 CKD), who were on a stable in-center hemodialysis regimen (approximately 4 hours 3 times per week) for ≥ 12 weeks prior to recruitment
- A cardiac evaluation was required within the last year to ensure adequate cardiac function
Who cannot join
- Any physical or psychological disability that would impact study participation, such as severe cerebrovascular disease (e.g., hemiparesis, cerebellar ataxia, etc.) or dementia
- Serum intact parathyroid hormone(iPTH)>250 pmol/L within 30 days prior to screening visit
- Dysrhythmia or severe cardiac disease, such as congestive heart failure (CHF) Class III-IV, or unstable cardiovascular disease within 90 days prior to recruitment
- Severe peripheral arterial disease
- Severe hyperkalemia (>6.5 milliequivalent/L) consistently the last 2 weeks
- Current active cancer (excluding basal cell carcinoma of the skin)
Show all 9Show fewer
- Poorly controlled hypertension (post-dialytic systolic blood pressure ≥ 160mmHg or diastolic blood pressure≥ 100 mmHg) within 4 weeks prior to recruitment
- Anticipated living donor kidney transplant or any other planned major surgery over the study duration
- History of poor treatment adherence
About this study
The purpose of this pilot study is to evaluate 1) the effect of intradialytic pedaling exercise on arterial stiffness and other arterial hemodynamic parameters over 4 months, and 2) the longer-term effect of pedaling on arterial stiffness and other arterial hemodynamic parameters 4 months after finishing the exercise intervention (8 months after study initiation).
The investigators also aim to examine the impact of intradialytic pedaling exercise on general health, anthropometric measures, physical function, and routine laboratory blood markers as secondary outcome measures, as well as to assess feasibility, safety and adverse events associated with the intradialytic pedalling exercise.
Recruitment of more participants in the future will be considered if warranted.
- Being tested
- Exercise
- Keywords
- arterial stiffness, hemodialysis, intradialytic pedalling exercise, carotid-femoral pulse wave velocity, chronic kidney disease, hemodynamics, augmentation index
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Intradialytic pedalling exercise during regular dialysis sessions (3x per week) for 4 months
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Participants will engage in pedalling exercise 3 times per week during the first 2 hours of dialysis treatment for the duration of 4 months. Receives: Other: Exercise |
| Usual care | No intervention | Participants receive their usual dialysis for the duration of 4 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in non-invasive measures of arterial stiffness using applanation tonometry.
Measured: 4 months and 8 months after study initiation
Secondary outcomes (3)
Change in gait speed using a 6 meter walk course and timer.
Measured: 4 months and 8 months after study initiation
Change in grip strength using a hand dynamometer.
Measured: 4 months and 8 months after study initiation
Safety and adverse events.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study startFeb 2015
- Primary completionNov 2015
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease Requiring Chronic DialysisStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Stella Daskalopoulou, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Stella S Daskalopoulou, MD, PhD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03027778
- Sponsor's protocol ID
- 12-309 GEN
- Status last verified
- Mar 2018
- First submitted
- 17 Jan 2017
- Last updated
- 21 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Bernier-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 35018639Cooke AB, Ta V, Iqbal S, Gomez YH, Mavrakanas T, Barre P, Vasilevsky M, Rahme E, Daskalopoulou SS. The Impact of Intradialytic Pedaling Exercise on Arterial Stiffness: A Pilot Randomized Controlled Trial in a Hemodialysis Population. Am J Hypertens. 2018 Mar 10;31(4):458-466. doi: 10.1093/ajh/hpx191.
PubMed 29126178
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intradialytic Pedalling Exercise and Vascular Hemodynamic Parameters Among Prevalent Hemodialysis Population
- ClinicalTrials.gov ID
- NCT03027778
- Acronym / sponsor ID
- 12-309 GEN
- Keywords
- arterial stiffness, hemodialysis, intradialytic pedalling exercise, carotid-femoral pulse wave velocity, chronic kidney disease, hemodynamics, augmentation index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 23 Jan 2017 (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.
The purpose of this pilot study is to evaluate 1) the effect of intradialytic pedaling exercise on arterial stiffness and other arterial hemodynamic parameters over 4 months, and 2) the longer-term effect of pedaling on arterial stiffness and other arterial hemodynamic parameters 4 months after finishing the exercise intervention (8 months after study initiation).
The investigators also aim to examine the impact of intradialytic pedaling exercise on general health, anthropometric measures, physical function, and routine laboratory blood markers as secondary outcome measures, as well as to assess feasibility, safety and adverse events associated with the intradialytic pedalling exercise.
Recruitment of more participants in the future will be considered if warranted.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: ExerciseParticipants will engage in pedalling exercise 3 times per week during the first 2 hours of dialysis treatment for the duration of 4 months. |
| Usual care | No intervention | –Participants receive their usual dialysis for the duration of 4 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults with end-stage renal disease (stage 5 CKD), who were on a stable in-center hemodialysis regimen (approximately 4 hours 3 times per week) for ≥ 12 weeks prior to recruitment
- A cardiac evaluation was required within the last year to ensure adequate cardiac function
Key exclusion criteria (9 listed)
- Any physical or psychological disability that would impact study participation, such as severe cerebrovascular disease (e.g., hemiparesis, cerebellar ataxia, etc.) or dementia
- Serum intact parathyroid hormone(iPTH)>250 pmol/L within 30 days prior to screening visit
- Dysrhythmia or severe cardiac disease, such as congestive heart failure (CHF) Class III-IV, or unstable cardiovascular disease within 90 days prior to recruitment
- Severe peripheral arterial disease
- Severe hyperkalemia (>6.5 milliequivalent/L) consistently the last 2 weeks
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 |
|---|---|---|
| ExerciseIntradialytic pedalling exercise during regular dialysis sessions (3x per week) for 4 months | Other | Exercise |
Primary outcome
Change in non-invasive measures of arterial stiffness using applanation tonometry.
Time frame: 4 months and 8 months after study initiation
3 secondary outcomes
Change in gait speed using a 6 meter walk course and timer.
Time frame: 4 months and 8 months after study initiation
Change in grip strength using a hand dynamometer.
Time frame: 4 months and 8 months after study initiation
Safety and adverse events.
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2018.
- 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 29126178Cooke AB, Ta V, Iqbal S, Gomez YH, Mavrakanas T, Barre P, Vasilevsky M, Rahme E, Daskalopoulou SS. The Impact of Intradialytic Pedaling Exercise on Arterial Stiffness: A Pilot Randomized Controlled Trial in a Hemodialysis Population. Am J Hypertens. 2018 Mar 10;31(4):458-466. doi: 10.1093/ajh/hpx191.
- Individual participant dataSharing planned: No
Related trials for Chronic Kidney Disease Requiring Chronic Dialysis
Recruiting
DIALysis With EXpanded Solute Removal
Chronic Kidney Disease Requiring Hemodialysis, End-Stage Kidney Disease (ESKD)
RecruitingPhase 2
A Study to Evaluate Safety, Tolerability and Efficacy of AP306 at Fixed Doses in Dialysis Participants With Hyperphosphatemia
Hyperphosphatemia, Chronic Kidney Disease Requiring Chronic Dialysis
Recruiting
Technology Assisted Collaborative Care Intervention to Improve Patient-centered Outcomes in Dialysis Patients
Chronic Kidney Disease Requiring Hemodialysis
Recruiting
Incremental Hemodialysis for Veterans in the First Year of Dialysis (IncHVets)
Chronic Kidney Disease (CKD) Stage 5, Kidney Dysfunction Requiring Dialysis (KDRD)
Recruiting
Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System
Kidney Disease, End-Stage, End-stage Renal Disease
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.
Stella S Daskalopoulou, MD, PhD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Chronic Kidney Disease Requiring Chronic Dialysis, run by McGill University Health Centre/Research Institute of the McGill University Health Centre.
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 2 inclusion and 9 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: finished, as of the sponsor's last update on 21 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in non-invasive measures of arterial stiffness using applanation tonometry. (time frame: 4 months and 8 months after study initiation). 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 NCT03027778, which also lists 2 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 21 Mar 2018.