Timing of Intradialytic Exercise and Its Impact on Intradialytic Hypotension

NCT03504943 | Completed

• 1 other identifier: HS21703 (B2018:035)
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Intradialytic Hypotension; Hemodialysis-Induced Symptoms

Keywords

Exercise; Hemodialysis; Intradialytic hypotension

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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.

  4 weeks

• Difference in time for recovery post-dialysis between the 2 study time periods (early and late intradialytic exercise)

  4 weeks

Study Arms (2)

Early Intradialytic Exercise

ACTIVE COMPARATOR

Intradialytic cycling will occur in the first half of hemodialysis treatment

Other: Early Intradialytic Exercise

Late Intradialytic Exercise

EXPERIMENTAL

Intradialytic cycling will occur in the second half of hemodialysis treatment

Other: Late Intradialytic Exercise

Interventions

Early Intradialytic Exercise OTHER

Timing of intradialytic exercise first half of HD

Early Intradialytic Exercise

Late Intradialytic Exercise OTHER

Timing of intradialytic exercise second half of HD

Late Intradialytic Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• dialysis frequency not three times per week

Sponsors & Collaborators

• University of Manitoba: lead
• University of Alberta: collaborator
• University of Calgary: collaborator

Study Sites (3)

University of Calgary Cumming School of Medicine Department of Internal Medicine

Calgary, Alberta, T2N 2T9, Canada

Location

University of Alberta Department of Internal Medicine

Edmonton, Alberta, T6G 2G3, Canada

Location

University of Manitoba Department of Internal Medicine

Winnipeg, Manitoba, R3A 1R9, Canada

Location

Related Publications (20)

• 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.

  PMID: 21175972 BACKGROUND

• Daugirdas JT, Blake PG, Ing TS. Handbook of Dialysis. Lippincott Williams & Wilkins; 2014.

  BACKGROUND

• K/DOQI Workgroup. K/DOQI clinical practice guidelines for cardiovascular disease in dialysis patients. Am J Kidney Dis. 2005 Apr;45(4 Suppl 3):S1-153. No abstract available.

  PMID: 15806502 BACKGROUND

• 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.

  PMID: 20967553 BACKGROUND

• Gul A, Miskulin D, Harford A, Zager P. Intradialytic hypotension. Curr Opin Nephrol Hypertens. 2016 Nov;25(6):545-550. doi: 10.1097/MNH.0000000000000271.

  PMID: 27606498 BACKGROUND

• Rocco 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.

  PMID: 8305644 BACKGROUND

• Iseki 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.

  PMID: 9083288 BACKGROUND

• Shoji 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.

  PMID: 15327420 BACKGROUND

• Momeni 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.

  PMID: 24878943 BACKGROUND

• Heiwe 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.

  PMID: 21975737 BACKGROUND

• Leung 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

• 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.

  PMID: 21412149 BACKGROUND

• Farese 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.

  PMID: 18487001 BACKGROUND

• Rhee 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.

  PMID: 28838226 BACKGROUND

• Dungey 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.

  PMID: 26619202 BACKGROUND

• Burton JO, Jefferies HJ, Selby NM, McIntyre CW. Hemodialysis-induced cardiac injury: determinants and associated outcomes. Clin J Am Soc Nephrol. 2009 May;4(5):914-20. doi: 10.2215/CJN.03900808. Epub 2009 Apr 8.

  PMID: 19357245 BACKGROUND

• Burton JO, Jefferies HJ, Selby NM, McIntyre CW. Hemodialysis-induced repetitive myocardial injury results in global and segmental reduction in systolic cardiac function. Clin J Am Soc Nephrol. 2009 Dec;4(12):1925-31. doi: 10.2215/CJN.04470709. Epub 2009 Oct 1.

  PMID: 19808220 BACKGROUND

• Flythe JE, Xue H, Lynch KE, Curhan GC, Brunelli SM. Association of mortality risk with various definitions of intradialytic hypotension. J Am Soc Nephrol. 2015 Mar;26(3):724-34. doi: 10.1681/ASN.2014020222. Epub 2014 Sep 30.

  PMID: 25270068 BACKGROUND

• Awuah KT, Afolalu BA, Hussein UT, Raducu RR, Bekui AM, Finkelstein FO. Time to recovery after a hemodialysis session: impact of selected variables. Clin Kidney J. 2013 Dec;6(6):595-8. doi: 10.1093/ckj/sft120. Epub 2013 Sep 29.

  PMID: 26069828 BACKGROUND

• Lindsay RM, Heidenheim PA, Nesrallah G, Garg AX, Suri R; Daily Hemodialysis Study Group London Health Sciences Centre. Minutes to recovery after a hemodialysis session: a simple health-related quality of life question that is reliable, valid, and sensitive to change. Clin J Am Soc Nephrol. 2006 Sep;1(5):952-9. doi: 10.2215/CJN.00040106. Epub 2006 Jul 6.

  PMID: 17699312 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Clara Bohm, MD, MPH

  University of Manitoba

  PRINCIPAL INVESTIGATOR

• Jennifer MacRae, MD,MSc

  University of Calgary

  PRINCIPAL INVESTIGATOR

• Stephanie Thompson, MD, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Nephrologist

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: April 20, 2018
• Study Start: July 9, 2018
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: October 18, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)