Exercise and Cardiac Stunning During HD

University of Manitoba

Status: Active, not recruiting

Conditions: Hemodialysis; End-stage Kidney Disease

Treatments: Behavioral: Intradialytic Cycling

Study type: Interventional

Funder types: Other

Identifiers

NCT04877041

HS24857 (B2021:039)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 (>2x/week in week prior to enrolment)
• Participating in clinical intradialytic cycling program in last 3 months (if a clinical program exists)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Exercise (Intradialytic Cycling)

Experimental group

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

Treatment:

Behavioral: Intradialytic Cycling

Usual Care

No Intervention group

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).