Clinical trial NCT04877041: 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
Overall status: RECRUITING
Phase: NA
Conditions: End-stage Kidney Disease
Hemodialysis
Keywords: intradialytic exercise
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2021-05-07
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Adults greater than or equal to 18 years old (no upper age limit); who are greater than; 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
* Must be dialyzing thrice weekly

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 (\&amp;gt;2x/week in week prior to enrolment)
* Participating in clinical intradialytic cycling program in last 3 months (if a clinical program exists)

Primary outcomes:
measure: Change in number of cardiac RWMA at peak hemodialysis stress (last 30 min HD) from baseline to 12 weeks measured using echocardiography
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Change in post-hemodialysis high sensitivity Troponin T level from baseline to 12 weeks
timeFrame: Baseline to 12 weeks
measure: Change in difference between pre-hemodialysis and post-hemodialysis Troponin T from baseline to 12 weeks
timeFrame: Baseline to 12 weeks
measure: Change in number of cardiac RWMA at peak hemodialysis stress (last 30 min HD) from baseline to 16 weeks measured using echocardiography
timeFrame: Baseline to 16 weeks
measure: Change in severity of post-hemodialysis fatigue
timeFrame: Baseline to 12 weeks
measure: Change in Symptom Burden
timeFrame: Baseline to 12 weeks
measure: Change in Exercise Capacity
timeFrame: Baseline to 12 weeks
measure: Change in Physical Activity Behaviour Patterns
timeFrame: Baseline to 12 weeks
measure: Change in number of regional wall motion abnormalities at peak HD stress
timeFrame: Baseline to 1 week
measure: Change in number of regional wall motion abnormalities at peak HD stress
timeFrame: Baseline to 16 weeks
measure: Feasiblity - Recruitment
timeFrame: Baseline to 12 weeks
measure: Feasibility - Eligibility
timeFrame: Baseline to 12 weeks
measure: Feasibility - Adherence
timeFrame: Baseline to 16 weeks
measure: Feasibility - Exercise Adherence: Proportion of exercise sessions completed
timeFrame: Baseline to 12 weeks
measure: Feasibility - Exercise Adherence: Total minutes of exercise
timeFrame: Baseline to 12 weeks
measure: Change in Cognitive Function
timeFrame: Baseline to 12 weeks
measure: Change in number of cardiac RWMA at peak hemodialysis stress (last 30 min HD) from 12 to 16 weeks measured using echocardiography
timeFrame: From 12 to 16 weeks
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: University of South Australia
state: South Australia
city: Calgary
country: Canada
facility: University of Calgary Cumming School of Medicine Department of Internal Medicine
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Department of Internal Medicine
state: Alberta
city: Vancouver
country: Canada
facility: St. Pauls Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: University of Manitoba Department of Internal Medicine
state: Manitoba
city: London
country: Canada
facility: Western University
state: Ontario
Study officials:
affiliation: University of Manitoba
name: Clara Bohm, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: