Boosting Myocardial Preconditioning With High-Intensity Intradialytic Exercise: A Preliminary Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in the number of left ventricular segments undergoing a greater than 20% reduction in longitudinal strain as detected by echocardiogram.
研究概览
简要总结
Patients receiving regular hemodialysis (HD) treatments are at a higher risk of cardiovascular events and death as HD can cause a decrease in the pumping of the heart during treatment called 'stunning'. Intradialytic exercise has emerged as a safe and effective non-drug approach to improve cardiovascular health and is now recommended for patients undergoing HD. It is currently advised that HD patients engage in at least 30 minutes of moderate to vigorous exercise three times per week. This study will evaluate the impact of exercise intensity in the HD population and determine if high impact exercise can offer better protection to the heart against HD-induced myocardial stunning.
详细描述
This will be the first randomized, cross-controlled trial evaluating the impact of exercise intensity in the HD population. If the efficacy of cardiovascular protection is proven, it could be developed as a therapeutic option in the dialysis population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be on chronic hemodialysis for at least 3 months
- •Age ≥ 18 years of age
- •Willing and able to provide informed consent
排除标准
- •Regular vigorous exercise outside hemodialysis
- •> 79 years of age
- •Intradialytic exercise in the past 3 months
- •Poor echogenicity
- •Acute coronary syndrome in the past 3 months
- •Unstable arrhythmia/angina
- •Shortness of breath at rest or with minimal activity
- •Symptomatic hypoglycemia (>2x/week in the week prior to enrolment)
- •Symptomatic peripheral arterial disease
- •Unable or deemed unsafe to exercise for any reason
- •Severe musculoskeletal or orthopedic conditions
- •Aortic stenosis
- •Hypertrophic cardiopathy
- •Severe pulmonary hypertension
- •Symptomatic hypertension
研究组 & 干预措施
Randomization Order 1
Participants will be randomized into one of the three conditions indicating the order in which they will receive the exercise intervention. Randomization Order 1 will receive control (no exercise) week one. Week 2 the participant will have a moderate intensity exercise treatment and week three the participant will have a high intensity exercise treatment. All sessions (i.e. HD-Cont, HD-Mod and HD-High) will be performed on one of the patient's three days of weekly dialysis. Each patient will consistently perform all sessions on the same day of dialysis throughout the study. The three sessions will be separate by at least one week to avoid potential carryover effects.
干预措施: Intradialytic Cycling (Other)
Randomization Order 2
Participants will be randomized into one of the three conditions indicating the order in which they will receive the exercise intervention. Randomization Order 2 will receive moderate intensity exercise week one. Week 2 the participant will have high intensity exercise and week three the participant will have control (no exercise). All sessions (i.e. HD-Cont, HD-Mod and HD-High) will be performed on one of the patient's three days of weekly dialysis. Each patient will consistently perform all sessions on the same day of dialysis throughout the study. The three sessions will be separate by at least one week to avoid potential carryover effects.
干预措施: Intradialytic Cycling (Other)
Randomization 3
Participants will be randomized into one of the three conditions indicating the order in which they will receive the exercise intervention. Randomization Order 3 will receive high intensity exercise week one. Week 2 the participant will have control (no exercise) and week three the participant will have a moderate intensity exercise treatment. All sessions (i.e. HD-Cont, HD-Mod and HD-High) will be performed on one of the patient's three days of weekly dialysis. Each patient will consistently perform all sessions on the same day of dialysis throughout the study. The three sessions will be separate by at least one week to avoid potential carryover effects.
干预措施: Intradialytic Cycling (Other)
结局指标
主要结局
Change in the number of left ventricular segments undergoing a greater than 20% reduction in longitudinal strain as detected by echocardiogram.
时间窗: Week 1 to Week 3
An echocardiogram will be completed pre-hemodialysis (HD) treatment and at peak hemodynamic stress (30 minutes before the end of HD treatment) at each of the study sessions. Images will be captured in the left lateral position and standard apical 4, and 2 chamber views will be recorded for analysis using automated speckle-training software. (EchoPac, GE Healthcare)
次要结局
- Evaluate whether the increase in exercise intensity leads to a differential modulation of potential cardioprotective mechanisms, by evaluating their effects on hemodynamic responses (Blood Pressure)(Week 1 to week 3)
- Evaluate whether the increase in exercise intensity leads to a differential modulation of potential cardioprotective mechanisms, by evaluating their effects on hemodynamic responses (Finapres)(Week 1 to Week 3)
- Evaluate potential targets of exercise induced cardio protection by evaluating their effects on endothelial function.(Week 1 to Week 3)
- Evaluate whether the increase in exercise intensity leads to a differential modulation of potential cardioprotective mechanisms, by evaluating their effects on hemodynamic responses (CV Insight Monitoring)(Week 1 to Week 3)
- Evaluate whether the increase in exercise intensity leads to a differential modulation of potential cardioprotective mechanisms, focusing on blood markers.(Week 1 to Week 3)
研究者
Chris McIntyre
Nephrologist
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's