Timing of Intradialytic Exercise and Its Impact on Intradialytic Hypotension: a Randomized Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 6
- 主要终点
- Difference in the rate of IDH (episodes of hypotension per 100 hours of HD) between the 2 study time periods (early and late intradialytic exercise)
研究概览
简要总结
The objective of this study is to compare the rate of low blood pressure events (Intradialytic Hypotension: IDH) when intradialytic exercise is performed in the first half of the hemodialysis (HD) session as compared to that when intradialytic exercise is performed in the second half of the HD session. The investigators expect that there will be little to no difference in occurrence of IDH episodes between the two time periods based on the experience of the 3 centres and imaging studies of the heart with exercise in HD.
详细描述
Intradialytic hypotension (IDH) is a common complication during hemodialysis, occurring in 20-30% of HD treatments. IDH can cause unpleasant symptoms and lead to decline in residual kidney function, vascular access thrombosis, ischemic damage to white matter of the brain, volume overload, increased risk of cardiovascular events and increased mortality risk.
Intradialytic exercise has been shown to improve physical function, health-related quality of life and cardiac function. Initial concerns regarding the potential for intradialytic exercise to increase the rate of IDH have been mitigated by multiple interventional studies in which intradialytic exercise has been shown to be safe with minimal adverse effects. However, concerns regarding the potential of intradialytic exercise to increase frequency of IDH if exercise is performed in second half of HD remain.
No study has specifically compared the frequency IDH episodes when exercise is performed during second half of HD as compared to that when exercise is performed during the first half of a HD session to fully characterize the effect of timing of intradialytic exercise and its effect on IDH.
The investigators aim to address this knowledge gap with a crossover study examining the rate of IDH when individuals in a clinical intradialytic cycling program exercise during the first half of their hemodialysis session as compared with the IDH rate when exercise is performed during the second half of hemodialysis.
To facilitate study implementation and optimize use of exercise resources and equipment, participants at each site will be randomly split into 2 groups. Group 1 will perform 2 weeks of their usual intradialytic cycling (6 sessions) during the first half of their usual HD and then perform 2 weeks of intradialytic cycling (6 sessions) during the second half of their usual HD. Group 2 will perform the intervention in reverse order to Group 1. No washout period is required as there is no biological plausibility for carry over effect. However, as participation in the cycling program is voluntary, some participants choose not to exercise during some of their HD sessions. The investigators will monitor these non-cycling sessions for IDH as well and will compare IDH rate in these non-exercise sessions with IDH rate during sessions when intradialytic exercise was performed, if numbers allow.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •adult (>= 18 years old), receiving three times per week chronic in-centre hemodialysis, current active participant in clinical intradialytic cycling program offered at each study site, able to communicate in English, able to provide written consent
排除标准
- •dialysis frequency not three times per week
结局指标
主要结局
Difference in the rate of IDH (episodes of hypotension per 100 hours of HD) between the 2 study time periods (early and late intradialytic exercise)
时间窗: 4 weeks
IDH will be defined as a composite of \>= 20 mmHg drop from baseline bp or a drop in systolic BP to \<90 mmHg
次要结局
- Difference in frequency and severity of dialysis-related symptoms as measured by the Dialysis Symptom Index between exercise performed in the first and second half of HD sessions.(4 weeks)
- Difference in rate of IDH (episodes of hypotension per 100 hours of HD) between the 2 study time periods AND associated symptoms OR requiring intervention by bedside nurse(4 weeks)
- Difference in time for recovery post-dialysis between the 2 study time periods (early and late intradialytic exercise)(4 weeks)
研究者
Clara Bohm
Associate Professor, Nephrologist
University of Manitoba