Trial of Intradialytic Cycling as Kidney Exercise Rehabilitation for Cardiac Stunning in Hemodialysis (TICKERS-HD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 12
- 主要终点
- Change in number of cardiac RWMA at peak hemodialysis stress (last 30 min HD) from baseline to 12 weeks measured using echocardiography
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Data analysts will also be blinded to study group
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Exercise (Intradialytic Cycling)
Participants will receive a standardized baseline exercise counseling session as per control and then participate in a supervised intradialytic cycling program for 12-weeks
干预措施: Intradialytic Cycling (Behavioral)
Usual Care
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).
结局指标
主要结局
Change in number of cardiac RWMA at peak hemodialysis stress (last 30 min HD) from baseline to 12 weeks measured using echocardiography
时间窗: Baseline to 12 weeks
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).
次要结局
- Feasibility - Exercise Adherence: Proportion of exercise sessions completed(Baseline to 12 weeks)
- Feasibility - Exercise Adherence: Total minutes of exercise(Baseline to 12 weeks)
- Change in Cognitive Function(Baseline to 12 weeks)
- Change in number of cardiac RWMA at peak hemodialysis stress (last 30 min HD) from 12 to 16 weeks measured using echocardiography(From 12 to 16 weeks)
- Change in post-hemodialysis high sensitivity Troponin T level from baseline to 12 weeks(Baseline to 12 weeks)
- Change in difference between pre-hemodialysis and post-hemodialysis Troponin T from baseline to 12 weeks(Baseline to 12 weeks)
- Change in number of cardiac RWMA at peak hemodialysis stress (last 30 min HD) from baseline to 16 weeks measured using echocardiography(Baseline to 16 weeks)
- Change in severity of post-hemodialysis fatigue(Baseline to 12 weeks)
- Change in Symptom Burden(Baseline to 12 weeks)
- Change in Exercise Capacity(Baseline to 12 weeks)
- Change in Physical Activity Behaviour Patterns(Baseline to 12 weeks)
- Change in number of regional wall motion abnormalities at peak HD stress(Baseline to 16 weeks)
- Feasiblity - Recruitment(Baseline to 12 weeks)
- Feasibility - Eligibility(Baseline to 12 weeks)
- Feasibility - Adherence(Baseline to 16 weeks)