Intradialytic Pedalling 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
- 32
- 主要终点
- Change in non-invasive measures of arterial stiffness using applanation tonometry.
研究概览
简要总结
The purpose of this pilot study is to evaluate 1) the effect of intradialytic pedaling exercise on arterial stiffness and other arterial hemodynamic parameters over 4 months, and 2) the longer-term effect of pedaling on arterial stiffness and other arterial hemodynamic parameters 4 months after finishing the exercise intervention (8 months after study initiation).
The investigators also aim to examine the impact of intradialytic pedaling exercise on general health, anthropometric measures, physical function, and routine laboratory blood markers as secondary outcome measures, as well as to assess feasibility, safety and adverse events associated with the intradialytic pedalling exercise.
Recruitment of more participants in the future will be considered if warranted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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 with end-stage renal disease (stage 5 CKD), who were on a stable in-center hemodialysis regimen (approximately 4 hours 3 times per week) for ≥ 12 weeks prior to recruitment
- •A cardiac evaluation was required within the last year to ensure adequate cardiac function
排除标准
- •Any physical or psychological disability that would impact study participation, such as severe cerebrovascular disease (e.g., hemiparesis, cerebellar ataxia, etc.) or dementia
- •Serum intact parathyroid hormone(iPTH)>250 pmol/L within 30 days prior to screening visit
- •Dysrhythmia or severe cardiac disease, such as congestive heart failure (CHF) Class III-IV, or unstable cardiovascular disease within 90 days prior to recruitment
- •Severe peripheral arterial disease
- •Severe hyperkalemia (>6.5 milliequivalent/L) consistently the last 2 weeks
- •Current active cancer (excluding basal cell carcinoma of the skin)
- •Poorly controlled hypertension (post-dialytic systolic blood pressure ≥ 160mmHg or diastolic blood pressure≥ 100 mmHg) within 4 weeks prior to recruitment
- •Anticipated living donor kidney transplant or any other planned major surgery over the study duration
- •History of poor treatment adherence
结局指标
主要结局
Change in non-invasive measures of arterial stiffness using applanation tonometry.
时间窗: 4 months and 8 months after study initiation
次要结局
- Change in gait speed using a 6 meter walk course and timer.(4 months and 8 months after study initiation)
- Change in grip strength using a hand dynamometer.(4 months and 8 months after study initiation)
- Safety and adverse events.(8 months)
研究者
Dr. Stella Daskalopoulou
Associate Professor in Medicine
McGill University Health Centre/Research Institute of the McGill University Health Centre