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Exercise and Cardiac Stunning During HD

Primary Purpose

End-stage Kidney Disease, Hemodialysis

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Intradialytic Cycling
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End-stage Kidney Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults > or equal to 18 years old (no upper age limit); who are > 3 months after starting maintenance hemodialysis
  • No expected change in dialysis modality, elective surgery or relocation outside of study site during the intervention period (16 weeks)
  • Assessed to be safe and able to exercise by the hemodialysis unit nephrologist
  • Able to communicate in English and provide written informed consent

Exclusion Criteria:

  • Acute coronary syndrome in the past 3 months
  • Unstable arrhythmia
  • Shortness of breath at rest or with minimal activity (NYHA Class 4)
  • Symptomatic hypoglycemia (>2x/week in week prior to enrolment)
  • Participating in clinical intradialytic cycling program in last 6 months (if a clinical program exists)

Sites / Locations

  • University of South Australia
  • University of Calgary Cumming School of Medicine Department of Internal MedicineRecruiting
  • University of Alberta Department of Internal Medicine
  • University of Manitoba Department of Internal MedicineRecruiting
  • University of Dalhouise
  • Western UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise (Intradialytic Cycling)

Usual Care

Arm Description

Participants will receive a standardized baseline exercise counseling session as per control and then participate in a supervised intradialytic cycling program for 12-weeks

Participants will receive a standardized baseline exercise counseling session. Participants in the control group will not undergo formal exercise intervention, but will not be prohibited from participating in exercise outside of hemodialysis. They will be asked to not to participate in intradialytic cycling during the study (16 weeks total).

Outcomes

Primary Outcome Measures

Change in number of cardiac RWMA at peak hemodialysis stress (last 30 min HD) from baseline to 12 weeks measured using echocardiography
Using standard left ventricular apical 2-, 3-, and 4-chamber views and left ventricular parasternal short-axis views collected by the same trained operator at each site 3 times during the mid-week hemodialysis session at each assessment time point as follows: baseline (pre hemodialysis), post-cycling exercise (or mid-dialysis in controls) and at peak hemodialysis stress (~30 min prior to end of hemodialysis). Echocardiogram image analysis will be performed in London, ON using automated speckle-tracking analysis (EchoPAC-PC software version 110.1.3; GE Healthcare).

Secondary Outcome Measures

Change in post-hemodialysis high sensitivity Troponin T level from baseline to 12 weeks
Measured by Roche High-Sensitivity Troponin T assay at each site.
Change in difference between pre-hemodialysis and post-hemodialysis Troponin T from baseline to 12 weeks
Measured by Roche High-Sensitivity Troponin T assay at each site.
Change in severity of post-hemodialysis fatigue
Assessed by the self-reported answer (in minutes) to the question: "How long does it take you to recover from a dialysis session and resume your normal, usual activities?"
Change in Symptom Burden
Measured using the Dialysis Symptom Index (DSI) Severity Score. Score 0 to 150 with 0 no symptoms and 150 most number and severity of symptoms
Change in Exercise Capacity
Measured by the Incremental Shuttle Walk Test (ISWT)
Change in Physical Activity Behaviour Patterns
Assessed using total active minutes per day as measure by multi-directional accelerometry
Change in number of regional wall motion abnormalities at peak HD stress
Measured at each study time point to further assess how exercise training effects HD-related cardiac stunning over time
Change in number of regional wall motion abnormalities at peak HD stress
Measured at each study time point to further assess how exercise training effects HD-related cardiac stunning over time
Feasiblity - Recruitment
Proportion of individuals eligible for study that were recruited
Feasibility - Eligibility
Proportion of individuals approached eligible for enrolment into study
Feasibility - Adherence
Proportion of participants that completed the study
Feasibility - Exercise Adherence: Proportion of exercise sessions completed
Proportion of total exercise sessions during study completed
Feasibility - Exercise Adherence: Total minutes of exercise
Proportion of total possible minutes of intradialytic cycling completed during the study
Change in Cognitive Function
Change in cognitive function score measured by Cambridge Brain Science testing

Full Information

First Posted
May 3, 2021
Last Updated
October 18, 2023
Sponsor
University of Manitoba
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT04877041
Brief Title
Exercise and Cardiac Stunning During HD
Official Title
Trial of Intradialytic Cycling as Kidney Exercise Rehabilitation for Cardiac Stunning in Hemodialysis (TICKERS-HD)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Manitoba
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine the effect of a 12-week cycling during hemodialysis program on hemodialysis-induced myocardial stunning in adult individuals receiving hemodialysis.
Detailed Description
People with kidney failure receiving chronic hemodialysis (HD) suffer from post-HD treatment fatigue, poor functional status and high rates of cardiac failure and death. Previous work has shown that these outcomes are correlated with recurrent ischemic cardiac injury (myocardial stunning) that occurs during HD treatments. Myocardial stunning, identified by regional cardiac wall motion abnormalities (RWMA), is common during HD. Intradialytic cycling (during HD) decreases HD-induced stunning, and may improve adverse outcomes associated with stunning. We will use echocardiography (echo) to understand the effects of intradialytic aerobic exercise on myocardial stunning and HD-related symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-stage Kidney Disease, Hemodialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Data analysts will also be blinded to study group
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise (Intradialytic Cycling)
Arm Type
Experimental
Arm Description
Participants will receive a standardized baseline exercise counseling session as per control and then participate in a supervised intradialytic cycling program for 12-weeks
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Participants will receive a standardized baseline exercise counseling session. Participants in the control group will not undergo formal exercise intervention, but will not be prohibited from participating in exercise outside of hemodialysis. They will be asked to not to participate in intradialytic cycling during the study (16 weeks total).
Intervention Type
Behavioral
Intervention Name(s)
Intradialytic Cycling
Intervention Description
This intervention will consist of intradialytic cycling for 60 minutes 3 times per week for a total of 12 weeks.
Primary Outcome Measure Information:
Title
Change in number of cardiac RWMA at peak hemodialysis stress (last 30 min HD) from baseline to 12 weeks measured using echocardiography
Description
Using standard left ventricular apical 2-, 3-, and 4-chamber views and left ventricular parasternal short-axis views collected by the same trained operator at each site 3 times during the mid-week hemodialysis session at each assessment time point as follows: baseline (pre hemodialysis), post-cycling exercise (or mid-dialysis in controls) and at peak hemodialysis stress (~30 min prior to end of hemodialysis). Echocardiogram image analysis will be performed in London, ON using automated speckle-tracking analysis (EchoPAC-PC software version 110.1.3; GE Healthcare).
Time Frame
Baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Change in post-hemodialysis high sensitivity Troponin T level from baseline to 12 weeks
Description
Measured by Roche High-Sensitivity Troponin T assay at each site.
Time Frame
Baseline to 12 weeks
Title
Change in difference between pre-hemodialysis and post-hemodialysis Troponin T from baseline to 12 weeks
Description
Measured by Roche High-Sensitivity Troponin T assay at each site.
Time Frame
Baseline to 12 weeks
Title
Change in severity of post-hemodialysis fatigue
Description
Assessed by the self-reported answer (in minutes) to the question: "How long does it take you to recover from a dialysis session and resume your normal, usual activities?"
Time Frame
Baseline to 12 weeks
Title
Change in Symptom Burden
Description
Measured using the Dialysis Symptom Index (DSI) Severity Score. Score 0 to 150 with 0 no symptoms and 150 most number and severity of symptoms
Time Frame
Baseline to 12 weeks
Title
Change in Exercise Capacity
Description
Measured by the Incremental Shuttle Walk Test (ISWT)
Time Frame
Baseline to 12 weeks
Title
Change in Physical Activity Behaviour Patterns
Description
Assessed using total active minutes per day as measure by multi-directional accelerometry
Time Frame
Baseline to 12 weeks
Title
Change in number of regional wall motion abnormalities at peak HD stress
Description
Measured at each study time point to further assess how exercise training effects HD-related cardiac stunning over time
Time Frame
Baseline to 1 week
Title
Change in number of regional wall motion abnormalities at peak HD stress
Description
Measured at each study time point to further assess how exercise training effects HD-related cardiac stunning over time
Time Frame
Baseline to 16 weeks
Title
Feasiblity - Recruitment
Description
Proportion of individuals eligible for study that were recruited
Time Frame
Baseline to 12 weeks
Title
Feasibility - Eligibility
Description
Proportion of individuals approached eligible for enrolment into study
Time Frame
Baseline to 12 weeks
Title
Feasibility - Adherence
Description
Proportion of participants that completed the study
Time Frame
Baseline to 16 weeks
Title
Feasibility - Exercise Adherence: Proportion of exercise sessions completed
Description
Proportion of total exercise sessions during study completed
Time Frame
Baseline to 12 weeks
Title
Feasibility - Exercise Adherence: Total minutes of exercise
Description
Proportion of total possible minutes of intradialytic cycling completed during the study
Time Frame
Baseline to 12 weeks
Title
Change in Cognitive Function
Description
Change in cognitive function score measured by Cambridge Brain Science testing
Time Frame
Baseline to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults > or equal to 18 years old (no upper age limit); who are > 3 months after starting maintenance hemodialysis No expected change in dialysis modality, elective surgery or relocation outside of study site during the intervention period (16 weeks) Assessed to be safe and able to exercise by the hemodialysis unit nephrologist Able to communicate in English and provide written informed consent Exclusion Criteria: Acute coronary syndrome in the past 3 months Unstable arrhythmia Shortness of breath at rest or with minimal activity (NYHA Class 4) Symptomatic hypoglycemia (>2x/week in week prior to enrolment) Participating in clinical intradialytic cycling program in last 6 months (if a clinical program exists)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clara Bohm, MD, MPH
Phone
204-631-3834
Email
cbohm@sogh.mb.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Emilie Ford, Bkin. MPH.
Phone
204-632-3834
Email
eford2@sogh.mb.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clara Bohm, MD, MPH
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Australia
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5001
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Bennett, PhD
First Name & Middle Initial & Last Name & Degree
Shilpa Jesudason, MD
Facility Name
University of Calgary Cumming School of Medicine Department of Internal Medicine
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer MacRae, MD, MSc
Phone
403-944-8168
Email
jennifer.macrae@albertahealthservices.ca
First Name & Middle Initial & Last Name & Degree
Jennifer MacRae, MD, MSc
Facility Name
University of Alberta Department of Internal Medicine
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2G3
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Thompson, MD, PhD
Phone
780-492-4228
Email
th11@ualberta.ca
First Name & Middle Initial & Last Name & Degree
Stephanie Thompson, Md, PhD
Facility Name
University of Manitoba Department of Internal Medicine
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emilie Ford, BKin; MPH
Phone
204-631-3834
Email
eford@sogh.mb.ca
First Name & Middle Initial & Last Name & Degree
Clara Bohm, MD, MPH
Facility Name
University of Dalhouise
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H2Y9
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karthik Tennankore, MD
First Name & Middle Initial & Last Name & Degree
Karthik Tennankore, MD
Facility Name
Western University
City
London
State/Province
Ontario
ZIP/Postal Code
N6A5C1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jarrin Penny, RN
First Name & Middle Initial & Last Name & Degree
Chris McIntyre, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Exercise and Cardiac Stunning During HD

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