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Timing of Intradialytic Exercise and Its Impact on Intradialytic Hypotension

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ClinicalTrials.gov Identifier: NCT03504943
Recruitment Status : Active, not recruiting
First Posted : April 20, 2018
Last Update Posted : March 25, 2019
Sponsor:
Collaborators:
University of Alberta
University of Calgary
Information provided by (Responsible Party):
Clara Bohm, University of Manitoba

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.

Condition or disease Intervention/treatment Phase
Intradialytic Hypotension Hemodialysis-Induced Symptoms Other: Early Intradialytic Exercise Other: Late Intradialytic Exercise Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Timing of Intradialytic Exercise and Its Impact on Intradialytic Hypotension: a Randomized Crossover Study
Actual Study Start Date : July 9, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Early Intradialytic Exercise
Intradialytic cycling will occur in the first half of hemodialysis treatment
Other: Early Intradialytic Exercise
Timing of intradialytic exercise first half of HD

Experimental: Late Intradialytic Exercise
Intradialytic cycling will occur in the second half of hemodialysis treatment
Other: Late Intradialytic Exercise
Timing of intradialytic exercise second half of HD




Primary Outcome Measures :
  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) [ 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


Secondary Outcome Measures :
  1. 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 ]
    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

  2. 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 ]
    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

  3. Difference in time for recovery post-dialysis between the 2 study time periods (early and late intradialytic exercise) [ Time Frame: 4 weeks ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • dialysis frequency not three times per week

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504943


Locations
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Canada, Alberta
University of Calgary Cumming School of Medicine Department of Internal Medicine
Calgary, Alberta, Canada, T2N 2T9
University of Alberta Department of Internal Medicine
Edmonton, Alberta, Canada, T6G 2G3
Canada, Manitoba
University of Manitoba Department of Internal Medicine
Winnipeg, Manitoba, Canada, R3A 1R9
Sponsors and Collaborators
University of Manitoba
University of Alberta
University of Calgary
Investigators
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Principal Investigator: 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

Publications:
Daugirdas 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.
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.

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Responsible Party: Clara Bohm, Assistant Professor, Nephrologist, University of Manitoba
ClinicalTrials.gov Identifier: NCT03504943     History of Changes
Other Study ID Numbers: HS21703 (B2018:035)
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Clara Bohm, University of Manitoba:
Exercise
Hemodialysis
Intradialytic hypotension

Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases