Exercise and Cardiac Stunning During HD

Hemodialysis Clinical Trial

Official title:

Trial of Intradialytic Cycling as Kidney Exercise Rehabilitation for Cardiac Stunning in Hemodialysis (TICKERS-HD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04877041
• Other study ID #: HS24857 (B2021:039)
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: September 2025

Study information

• Verified date: March 2024
• Source: University of Manitoba
• Contact: Clara Bohm, MD, MPH
• Phone: 204-631-3834
• Email: cbohm[@]sogh.mb.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: September 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 3 months (if a clinical program exists)

Related Conditions & MeSH terms

• End-stage Kidney Disease
• Hemodialysis
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Behavioral:
• Intradialytic Cycling
This intervention will consist of intradialytic cycling for 60 minutes 3 times per week for a total of 12 weeks.

Locations

Country	Name	City	State
Australia	University of South Australia	Adelaide	South Australia
Canada	University of Calgary Cumming School of Medicine Department of Internal Medicine	Calgary	Alberta
Canada	University of Alberta Department of Internal Medicine	Edmonton	Alberta
Canada	Western University	London	Ontario
Canada	University of Manitoba Department of Internal Medicine	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	Canadian Institutes of Health Research (CIHR)

Countries where clinical trial is conducted

Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline to 12 weeks
Secondary	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.	Baseline to 12 weeks
Secondary	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.	Baseline to 12 weeks
Secondary	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?"	Baseline to 12 weeks
Secondary	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	Baseline to 12 weeks
Secondary	Change in Exercise Capacity	Measured by the Incremental Shuttle Walk Test (ISWT)	Baseline to 12 weeks
Secondary	Change in Physical Activity Behaviour Patterns	Assessed using total active minutes per day as measure by multi-directional accelerometry	Baseline to 12 weeks
Secondary	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	Baseline to 1 week
Secondary	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	Baseline to 16 weeks
Secondary	Feasiblity - Recruitment	Proportion of individuals eligible for study that were recruited	Baseline to 12 weeks
Secondary	Feasibility - Eligibility	Proportion of individuals approached eligible for enrolment into study	Baseline to 12 weeks
Secondary	Feasibility - Adherence	Proportion of participants that completed the study	Baseline to 16 weeks
Secondary	Feasibility - Exercise Adherence: Proportion of exercise sessions completed	Proportion of total exercise sessions during study completed	Baseline to 12 weeks
Secondary	Feasibility - Exercise Adherence: Total minutes of exercise	Proportion of total possible minutes of intradialytic cycling completed during the study	Baseline to 12 weeks
Secondary	Change in Cognitive Function	Change in cognitive function score measured by Cambridge Brain Science testing	Baseline to 12 weeks