Aerobic Exercise and Vascular Hemodynamic Parameters Among Prevalent Hemodialysis Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 4
- 主要终点
- Change from Baseline in Gait speed
研究概览
简要总结
Arterial calcification is very common in the incident hemodialysis population, ranging 71-83%.Given that cardiovascular disease is a major cause of mortality in the hemodialysis population, medial arterial calcification may contribute through increased risk of sudden death and congestive heart failure. Applanation tonometry is the method of choice to measure pulse wave velocity and pulse wave analysis. The primary objective will be to assess the effect of a 16 week exercise program on aortic pulse wave velocity as the vascular parameter and gait speed as the physical functioning parameter. The secondary objectives will assess the effect of the exercise program on ultrafiltration rates, weight, SBP, DBP, BNP, hsTroponin, serum calcium, phosphate, albumin, glucose, LDL, HDL, TG, glycated hemoglobin, hemoglobin, CRP, micro RNAs (21, 126, 133, 146a, 221/222 and 210) and hospitalizations.
详细描述
The investigators propose a pilot project to assess the effect of a 16 week aerobic exercise program on arterial stiffness and cardiovascular risk in the hemodialysis population. The primary objective will be to assess the effect of a 16 week exercise program on aortic pulse wave velocity as the vascular parameter and gait speed as the physical functioning parameter. The secondary objectives will assess the effect of the exercise program on ultrafiltration rates, weight, SBP, DBP, BNP, hsTroponin, serum calcium, phosphate, albumin, glucose, LDL, HDL, TG, glycated hemoglobin, hemoglobin, CRP, micro RNAs (21, 126, 133, 146a, 221/222 and 210) and hospitalizations.
Study Design:
Randomized-controlled study of end stage renal disease patients between the age of 18 and 90 years to assess the effect of exercise on arterial stiffness. Our aim is to have 23 patients in both groups. The study period will be 24 weeks-4 weeks for recruitment, 16 weeks for the intervention and 4 weeks for data collection and analysis. The protocol will be submitted to the MUHC Research Ethics Board.
The following outcomes are of interest:
- change in gait speed before and after the exercise program
- change in pulse wave velocity before and after the exercise program
- change in BNP, blood pressure, dialysis ultrafiltration, hemoglobin, micro RNAs before and after the exercise program
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 18-95 years
- •Able to comply with the study procedures and medication
- •Written informed consent given
- •On a stable in-center hemodialysis regimen (at least 3 times per week) for ≥ 12 weeks prior to recruitment
- •Cardiac evaluation within the year with adequate cardiac function to be able to undergo the exercise program
排除标准
- •Participation in any clinical trial using an investigational product or device during the 30 days preceding recruitment
- •Any physical or psychological disability that would impact study participation, such as severe cerebrovascular disease (ie. hemiparesis, cerebellar ataxia, etc.) or dementia
- •Serum iPTH > 250 pmol/L within 30 days prior to screening visit
- •Dysrhythmia or severe cardiac disease: CHF Class III-IV; unstable cardiovascular diagnosis (for example MI, CABG, PTCA, CVA, and TIA) within 90 days prior to recruitment
- •Severe peripheral vascular disease
- •Severe hyperkalemia (>6.5 mmol/L) consistently for the last 2 weeks
- •Current active cancer (excluding basal cell carcinoma of the skin)
- •Poorly controlled hypertension (systolic > 180mmHg or diastolic > 100mmHg) within 4 weeks prior to recruitment
- •Anticipated live donor kidney transplant or any other planned major surgery over the study duration
- •History of poor adherence to hemodialysis or medical regimen
- •Any disease or condition, physical or psychological that, in the opinion of the investigator, would compromise the safety of the subject or the likelihood of achieving reliable results or increase the likelihood of the subject being withdrawn
结局指标
主要结局
Change from Baseline in Gait speed
时间窗: at 24 weeks and 48 weeks
The gait speed will be measured with a timer (in seconds) as the subject will be asked to walk a 10 foot or 3 meter course and back as quickly as possible. Two readings will be taken and the average will be recorded.
次要结局
- Change from Baseline Pulse wave analysis(at 24 and 48 weeks)
- Change from Baseline Pulse wave velocity (PWV)(at 24 weeks and 48 weeks)
- Change from baseline Rand survey(at 24 weeks and 48 weeks)
研究者
Sameena Iqbal
MD FRCP MSc.
McGill University Health Centre/Research Institute of the McGill University Health Centre