Intradialytic HypotensionNCT03504943
Timing of Intradialytic Exercise and Its Impact on Intradialytic Hypotension
A study testing Early Intradialytic Exercise and Late Intradialytic Exercise in people with Intradialytic Hypotension and Hemodialysis-Induced Symptoms, run by University of Manitoba at 3 sites in Canada.
Trial summary
The objective of this study is to compare the rate of low blood pressure events (Intradialytic Hypotension: IDH) when intradialytic exercise is performed in the first half of the hemodialysis (HD) session as compared to that when intradialytic exercise is performed in the second half of the HD session. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intradialytic Hypotension, Hemodialysis-Induced Symptoms
- What is being tested?
- Early Intradialytic Exercise and Late Intradialytic Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 3 sitesCanada
- Study dates
- 9 Jul 2018to 30 Apr 2019
- 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
- adult (>= 18 years old), receiving three times per week chronic in-centre hemodialysis, current active participant in clinical intradialytic cycling program offered at each study site, able to communicate in English, able to provide written consent
Who cannot join
- dialysis frequency not three times per week
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
University of Calgary Cumming School of Medicine Department of Internal Medicine
Calgary, Alberta, T2N 2T9
University of Alberta Department of Internal Medicine
Edmonton, Alberta, T6G 2G3
University of Manitoba Department of Internal Medicine
Winnipeg, Manitoba, R3A 1R9
About this study
Official title: Timing of Intradialytic Exercise and Its Impact on Intradialytic Hypotension: a Randomized Crossover Study
The objective of this study is to compare the rate of low blood pressure events (Intradialytic Hypotension: IDH) when intradialytic exercise is performed in the first half of the hemodialysis (HD) session as compared to that when intradialytic exercise is performed in the second half of the HD session. The investigators expect that there will be little to no difference in occurrence of IDH episodes between the two time periods based on the experience of the 3 centres and imaging studies of the heart with exercise in HD.
Read the detailed description
Intradialytic hypotension (IDH) is a common complication during hemodialysis, occurring in 20-30% of HD treatments. IDH can cause unpleasant symptoms and lead to decline in residual kidney function, vascular access thrombosis, ischemic damage to white matter of the brain, volume overload, increased risk of cardiovascular events and increased mortality risk.
Intradialytic exercise has been shown to improve physical function, health-related quality of life and cardiac function. Initial concerns regarding the potential for intradialytic exercise to increase the rate of IDH have been mitigated by multiple interventional studies in which intradialytic exercise has been shown to be safe with minimal adverse effects. However, concerns regarding the potential of intradialytic exercise to increase frequency of IDH if exercise is performed in second half of HD remain.
No study has specifically compared the frequency IDH episodes when exercise is performed during second half of HD as compared to that when exercise is performed during the first half of a HD session to fully characterize the effect of timing of intradialytic exercise and its effect on IDH.
The investigators aim to address this knowledge gap with a crossover study examining the rate of IDH when individuals in a clinical intradialytic cycling program exercise during the first half of their hemodialysis session as compared with the IDH rate when exercise is performed during the second half of hemodialysis.
To facilitate study implementation and optimize use of exercise resources and equipment, participants at each site will be randomly split into 2 groups. Group 1 will perform 2 weeks of their usual intradialytic cycling (6 sessions) during the first half of their usual HD and then perform 2 weeks of intradialytic cycling (6 sessions) during the second half of their usual HD. Group 2 will perform the intervention in reverse order to Group 1. No washout period is required as there is no biological plausibility for carry over effect. However, as participation in the cycling program is voluntary, some participants choose not to exercise during some of their HD sessions. The investigators will monitor these non-cycling sessions for IDH as well and will compare IDH rate in these non-exercise sessions with IDH rate during sessions when intradialytic exercise was performed, if numbers allow.
Participants will perform their usual duration and intensity of intradialytic cycling at each HD session as per standard clinical intradialytic cycling protocol procedures in each unit. Prescribed exercise time and intensity will remain unchanged over the course of the study.
The investigators will attempt to keep dialysate composition, dialyzer, dialysate temperature, HD access, dialysis duration and medications unchanged over the course of the study, but will not intervene/interfere with usual clinical care. The research assistant will record any changes to dialysis prescription related to routine clinical care on a weekly basis.
Baseline demographic and clinical data will be collected from the hemodialysis chart. This will include age, sex, race, time on hemodialysis, hemodialysis access, dialysis vintage, comorbidities (including hypertension, diabetes, congestive heart failure and ischemic heart disease), amount of fluid removed at each HD, hemoglobin, Kt/V (dialysis efficacy), medications and blood work results as measured on last monthly bloodwork.
The investigators will use the initial BP measurement obtained once the patient has commenced HD (i.e. patient "hooked up" and blood present in both venous and arterial lines) for the baseline BP. Blood pressure (BP) will be measured as per routine procedures used in the participants' HD units (usual arm/leg, usual BP cuff). Pre and post HD BP will be collected as per usual HD Unit practice. During HD, BP will be collected more frequently than the usual routine (q30 min) at q15min intervals or more frequently when clinically indicated based on patient symptoms or status. This timing will be pre-programmed into HD machines to minimize work for bedside HD nurses. However, bedside HD nurses will need to record each measurement on the HD run sheet.
- Being tested
- Early Intradialytic Exercise, Late Intradialytic Exercise
- Keywords
- Exercise, Hemodialysis, Intradialytic hypotension
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Intradialytic ExerciseOther
Timing of intradialytic exercise first half of HD
Late Intradialytic ExerciseOther
Timing of intradialytic exercise second half of HD
| Study group | Role | What they receive |
|---|---|---|
| Early Intradialytic Exercise | Active comparator | Intradialytic cycling will occur in the first half of hemodialysis treatment Receives: Other: Early Intradialytic Exercise |
| Late Intradialytic Exercise | Experimental | Intradialytic cycling will occur in the second half of hemodialysis treatment Receives: Other: Late Intradialytic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the rate of IDH (episodes of hypotension per 100 hours of HD) between the 2 study time periods (early and late intradialytic exercise)
IDH will be defined as a composite of >= 20 mmHg drop from baseline bp or a drop in systolic BP to <90 mmHg
Measured: 4 weeks
Secondary outcomes (3)
Difference in rate of IDH (episodes of hypotension per 100 hours of HD) between the 2 study time periods AND associated symptoms OR requiring intervention by bedside nurse
IDH as defined by a >20 mmHg drop from baseline BP. IDH associated symptoms as follows: abdominal discomfort, yawning, sighing, nausea, vomiting, muscle cramps, restlessness, dizziness or fainting, and anxiety
Measured: 4 weeks
Difference in frequency and severity of dialysis-related symptoms as measured by the Dialysis Symptom Index between exercise performed in the first and second half of HD sessions.
Frequency and severity of symptoms will be measured using the symptom burden score as measured by the Dialysis Symptom Index (DSI). The DSI is a 30-item self-administered questionnaire with low administrative burden that measures the presence (yes/no) and severity (5 point Likert-scale) of common symptoms in HD patients (cramping, nausea, dizziness, fatigue, chest pain and shortness of breath) and has been shown to be reliable and valid. Participants will complete the DSI at time of consent and then weekly at the end of the midweek HD session for the duration of the study
Measured: 4 weeks
Difference in time for recovery post-dialysis between the 2 study time periods (early and late intradialytic exercise)
Participants will be asked to answer the question "Approximately how much time does it take to recover from a dialysis session?" at each study assessment. Answers will be recorded in minutes.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start9 Jul 2018
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Intradialytic HypotensionStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alberta, University of Calgary
- Responsible party
- Principal investigator, Clara Bohm, University of Manitoba
- Investigators
- Clara Bohm, MD, MPH, Principal investigator, University of ManitobaJennifer MacRae, MD,MSc, Principal investigator, University of CalgaryStephanie Thompson, MD, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03504943
- Sponsor's protocol ID
- HS21703 (B2018:035)
- Status last verified
- Oct 2022
- First submitted
- 12 Apr 2018
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Damasiewicz MJ, Polkinghorne KR. Intra-dialytic hypotension and blood volume and blood temperature monitoring. Nephrology (Carlton). 2011 Jan;16(1):13-8. doi: 10.1111/j.1440-1797.2010.01362.x.
PubMed 21175972Daugirdas JT, Blake PG, Ing TS. Handbook of Dialysis. Lippincott Williams & Wilkins; 2014.
NKF. NKF KDOQI Clinical Practice Guidelines for Cardiovascular Disease in Dialysis Patients. 2005; http://www.kidney.org/professionals/kdoqi/guidelines_cvd/guide14.htm. Accessed Sept 13, 2013, 2013.
Hayes W, Hothi DK. Intradialytic hypotension. Pediatr Nephrol. 2011 Jun;26(6):867-79. doi: 10.1007/s00467-010-1661-4. Epub 2010 Oct 22.
PubMed 20967553Gul A, Miskulin D, Harford A, Zager P. Intradialytic hypotension. Curr Opin Nephrol Hypertens. 2016 Nov;25(6):545-550. doi: 10.1097/MNH.0000000000000271.
PubMed 27606498Rocco MV, Burkart JM. Prevalence of missed treatments and early sign-offs in hemodialysis patients. J Am Soc Nephrol. 1993 Nov;4(5):1178-83. doi: 10.1681/ASN.V451178.
PubMed 8305644Iseki K, Miyasato F, Tokuyama K, Nishime K, Uehara H, Shiohira Y, Sunagawa H, Yoshihara K, Yoshi S, Toma S, Kowatari T, Wake T, Oura T, Fukiyama K. Low diastolic blood pressure, hypoalbuminemia, and risk of death in a cohort of chronic hemodialysis patients. Kidney Int. 1997 Apr;51(4):1212-7. doi: 10.1038/ki.1997.165.
PubMed 9083288Shoji T, Tsubakihara Y, Fujii M, Imai E. Hemodialysis-associated hypotension as an independent risk factor for two-year mortality in hemodialysis patients. Kidney Int. 2004 Sep;66(3):1212-20. doi: 10.1111/j.1523-1755.2004.00812.x.
PubMed 15327420Momeni A, Nematolahi A, Nasr M. Effect of intradialytic exercise on echocardiographic findings in hemodialysis patients. Iran J Kidney Dis. 2014 May;8(3):207-11.
PubMed 24878943Heiwe S, Jacobson SH. Exercise training for adults with chronic kidney disease. Cochrane Database Syst Rev. 2011 Oct 5;2011(10):CD003236. doi: 10.1002/14651858.CD003236.pub2.
PubMed 21975737Leung K, Quinn RR, Ravani P, et al. Exercise Training During Hemodialysis is not Associated with Intradialytic Hypotension. Canadian Society of Nephrology Annual Meeting; April 25, 2017, 2014; Vancouver, B.C.
Giannaki CD, Stefanidis I, Karatzaferi C, Liakos N, Roka V, Ntente I, Sakkas GK. The effect of prolonged intradialytic exercise in hemodialysis efficiency indices. ASAIO J. 2011 May-Jun;57(3):213-8. doi: 10.1097/MAT.0b013e318215dc9e.
PubMed 21412149Farese S, Budmiger R, Aregger F, Bergmann I, Frey FJ, Uehlinger DE. Effect of transcutaneous electrical muscle stimulation and passive cycling movements on blood pressure and removal of urea and phosphate during hemodialysis. Am J Kidney Dis. 2008 Oct;52(4):745-52. doi: 10.1053/j.ajkd.2008.03.017. Epub 2008 May 19.
PubMed 18487001Rhee SY, Song JK, Hong SC, Choi JW, Jeon HJ, Shin DH, Ji EH, Choi EH, Lee J, Kim A, Choi SW, Oh J. Intradialytic exercise improves physical function and reduces intradialytic hypotension and depression in hemodialysis patients. Korean J Intern Med. 2019 May;34(3):588-598. doi: 10.3904/kjim.2017.020. Epub 2017 Aug 25.
PubMed 28838226Dungey M, Bishop NC, Young HM, Burton JO, Smith AC. The Impact of Exercising During Haemodialysis on Blood Pressure, Markers of Cardiac Injury and Systemic Inflammation--Preliminary Results of a Pilot Study. Kidney Blood Press Res. 2015;40(6):593-604. doi: 10.1159/000368535. Epub 2015 Nov 18.
PubMed 26619202
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Intradialytic Exercise and Its Impact on Intradialytic Hypotension: a Randomized Crossover Study
- ClinicalTrials.gov ID
- NCT03504943
- Acronym / sponsor ID
- HS21703 (B2018:035)
- Keywords
- Exercise, Hemodialysis, Intradialytic hypotension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- University of Alberta, University of Calgary
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 20 Apr 2018 (actual)
- 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 objective of this study is to compare the rate of low blood pressure events (Intradialytic Hypotension: IDH) when intradialytic exercise is performed in the first half of the hemodialysis (HD) session as compared to that when intradialytic exercise is performed in the second half of the HD session. The investigators expect that there will be little to no difference in occurrence of IDH episodes between the two time periods based on the experience of the 3 centres and imaging studies of the heart with exercise in HD.
Detailed description
Intradialytic hypotension (IDH) is a common complication during hemodialysis, occurring in 20-30% of HD treatments. IDH can cause unpleasant symptoms and lead to decline in residual kidney function, vascular access thrombosis, ischemic damage to white matter of the brain, volume overload, increased risk of cardiovascular events and increased mortality risk.
Intradialytic exercise has been shown to improve physical function, health-related quality of life and cardiac function. Initial concerns regarding the potential for intradialytic exercise to increase the rate of IDH have been mitigated by multiple interventional studies in which intradialytic exercise has been shown to be safe with minimal adverse effects. However, concerns regarding the potential of intradialytic exercise to increase frequency of IDH if exercise is performed in second half of HD remain.
No study has specifically compared the frequency IDH episodes when exercise is performed during second half of HD as compared to that when exercise is performed during the first half of a HD session to fully characterize the effect of timing of intradialytic exercise and its effect on IDH.
The investigators aim to address this knowledge gap with a crossover study examining the rate of IDH when individuals in a clinical intradialytic cycling program exercise during the first half of their hemodialysis session as compared with the IDH rate when exercise is performed during the second half of hemodialysis.
To facilitate study implementation and optimize use of exercise resources and equipment, participants at each site will be randomly split into 2 groups. Group 1 will perform 2 weeks of their usual intradialytic cycling (6 sessions) during the first half of their usual HD and then perform 2 weeks of intradialytic cycling (6 sessions) during the second half of their usual HD. Group 2 will perform the intervention in reverse order to Group 1. No washout period is required as there is no biological plausibility for carry over effect. However, as participation in the cycling program is voluntary, some participants choose not to exercise during some of their HD sessions. The investigators will monitor these non-cycling sessions for IDH as well and will compare IDH rate in these non-exercise sessions with IDH rate during sessions when intradialytic exercise was performed, if numbers allow.
Participants will perform their usual duration and intensity of intradialytic cycling at each HD session as per standard clinical intradialytic cycling protocol procedures in each unit. Prescribed exercise time and intensity will remain unchanged over the course of the study.
The investigators will attempt to keep dialysate composition, dialyzer, dialysate temperature, HD access, dialysis duration and medications unchanged over the course of the study, but will not intervene/interfere with usual clinical care. The research assistant will record any changes to dialysis prescription related to routine clinical care on a weekly basis.
Baseline demographic and clinical data will be collected from the hemodialysis chart. This will include age, sex, race, time on hemodialysis, hemodialysis access, dialysis vintage, comorbidities (including hypertension, diabetes, congestive heart failure and ischemic heart disease), amount of fluid removed at each HD, hemoglobin, Kt/V (dialysis efficacy), medications and blood work results as measured on last monthly bloodwork.
The investigators will use the initial BP measurement obtained once the patient has commenced HD (i.e. patient "hooked up" and blood present in both venous and arterial lines) for the baseline BP. Blood pressure (BP) will be measured as per routine procedures used in the participants' HD units (usual arm/leg, usual BP cuff). Pre and post HD BP will be collected as per usual HD Unit practice. During HD, BP will be collected more frequently than the usual routine (q30 min) at q15min intervals or more frequently when clinically indicated based on patient symptoms or status. This timing will be pre-programmed into HD machines to minimize work for bedside HD nurses. However, bedside HD nurses will need to record each measurement on the HD run sheet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Intradialytic Exercise | Active comparator | Other: Early Intradialytic ExerciseIntradialytic cycling will occur in the first half of hemodialysis treatment |
| Late Intradialytic Exercise | Experimental | Other: Late Intradialytic ExerciseIntradialytic cycling will occur in the second half of hemodialysis treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult (>= 18 years old), receiving three times per week chronic in-centre hemodialysis, current active participant in clinical intradialytic cycling program offered at each study site, able to communicate in English, able to provide written consent
Key exclusion criteria (1 listed)
- dialysis frequency not three times per week
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 |
|---|---|---|
| Early Intradialytic ExerciseTiming of intradialytic exercise first half of HD | Other | Early Intradialytic Exercise |
| Late Intradialytic ExerciseTiming of intradialytic exercise second half of HD | Other | Late Intradialytic Exercise |
Primary outcome
Difference in the rate of IDH (episodes of hypotension per 100 hours of HD) between the 2 study time periods (early and late intradialytic exercise)
Time frame: 4 weeks
IDH will be defined as a composite of >= 20 mmHg drop from baseline bp or a drop in systolic BP to <90 mmHg
3 secondary outcomes
Difference in rate of IDH (episodes of hypotension per 100 hours of HD) between the 2 study time periods AND associated symptoms OR requiring intervention by bedside nurse
Time frame: 4 weeks
Difference in frequency and severity of dialysis-related symptoms as measured by the Dialysis Symptom Index between exercise performed in the first and second half of HD sessions.
Time frame: 4 weeks
Difference in time for recovery post-dialysis between the 2 study time periods (early and late intradialytic exercise)
Time frame: 4 weeks
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 18 Oct 2022.
- Background: PubMed 21175972Damasiewicz MJ, Polkinghorne KR. Intra-dialytic hypotension and blood volume and blood temperature monitoring. Nephrology (Carlton). 2011 Jan;16(1):13-8. doi: 10.1111/j.1440-1797.2010.01362.x.
- BackgroundDaugirdas JT, Blake PG, Ing TS. Handbook of Dialysis. Lippincott Williams & Wilkins; 2014.
- BackgroundNKF. NKF KDOQI Clinical Practice Guidelines for Cardiovascular Disease in Dialysis Patients. 2005; http://www.kidney.org/professionals/kdoqi/guidelines_cvd/guide14.htm. Accessed Sept 13, 2013, 2013.
- Background: PubMed 20967553Hayes W, Hothi DK. Intradialytic hypotension. Pediatr Nephrol. 2011 Jun;26(6):867-79. doi: 10.1007/s00467-010-1661-4. Epub 2010 Oct 22.
- Background: PubMed 27606498Gul A, Miskulin D, Harford A, Zager P. Intradialytic hypotension. Curr Opin Nephrol Hypertens. 2016 Nov;25(6):545-550. doi: 10.1097/MNH.0000000000000271.
- Background: PubMed 8305644Rocco MV, Burkart JM. Prevalence of missed treatments and early sign-offs in hemodialysis patients. J Am Soc Nephrol. 1993 Nov;4(5):1178-83. doi: 10.1681/ASN.V451178.
- Background: PubMed 9083288Iseki K, Miyasato F, Tokuyama K, Nishime K, Uehara H, Shiohira Y, Sunagawa H, Yoshihara K, Yoshi S, Toma S, Kowatari T, Wake T, Oura T, Fukiyama K. Low diastolic blood pressure, hypoalbuminemia, and risk of death in a cohort of chronic hemodialysis patients. Kidney Int. 1997 Apr;51(4):1212-7. doi: 10.1038/ki.1997.165.
- Background: PubMed 15327420Shoji T, Tsubakihara Y, Fujii M, Imai E. Hemodialysis-associated hypotension as an independent risk factor for two-year mortality in hemodialysis patients. Kidney Int. 2004 Sep;66(3):1212-20. doi: 10.1111/j.1523-1755.2004.00812.x.
- Background: PubMed 24878943Momeni A, Nematolahi A, Nasr M. Effect of intradialytic exercise on echocardiographic findings in hemodialysis patients. Iran J Kidney Dis. 2014 May;8(3):207-11.
- Background: PubMed 21975737Heiwe S, Jacobson SH. Exercise training for adults with chronic kidney disease. Cochrane Database Syst Rev. 2011 Oct 5;2011(10):CD003236. doi: 10.1002/14651858.CD003236.pub2.
- BackgroundLeung K, Quinn RR, Ravani P, et al. Exercise Training During Hemodialysis is not Associated with Intradialytic Hypotension. Canadian Society of Nephrology Annual Meeting; April 25, 2017, 2014; Vancouver, B.C.
- Background: PubMed 21412149Giannaki CD, Stefanidis I, Karatzaferi C, Liakos N, Roka V, Ntente I, Sakkas GK. The effect of prolonged intradialytic exercise in hemodialysis efficiency indices. ASAIO J. 2011 May-Jun;57(3):213-8. doi: 10.1097/MAT.0b013e318215dc9e.
- Individual participant dataSharing planned: No
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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.
Clara Bohm, MD, MPH principal investigator
University of Manitoba
Jennifer MacRae, MD,MSc principal investigator
University of Calgary
Stephanie Thompson, MD, PhD principal investigator
University of Alberta
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Intradialytic Exercise and Late Intradialytic Exercise in people with Intradialytic Hypotension and Hemodialysis-Induced Symptoms, run by University of Manitoba at 3 sites in Canada.
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 1 inclusion and 1 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 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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?
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?
Difference in the rate of IDH (episodes of hypotension per 100 hours of HD) between the 2 study time periods (early and late intradialytic exercise) (time frame: 4 weeks). 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 NCT03504943, which also lists 20 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 18 Oct 2022.