A Randomized Controlled Trial of Aerobic Exercise in Patients With End Stage Renal Disease During Outpatient Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Aerobic exercise capacity as measured by VO2 peak
研究概览
简要总结
Randomized controlled trial comparing effects of ergometer exercise during hemodialysis to effects of pedometer use outside of hemodialysis on exercise capacity, functional status, quality of life and adequacy of hemodialysis.
详细描述
Study Design:
Prospective, randomized, controlled trial of chronic hemodialysis outpatients within the Manitoba Renal Program.
Potential patients include any individual receiving chronic outpatient hemodialysis in Winnipeg (Seven Oaks, Sherbrook, Central and St. Boniface dialysis units) and the Brandon hemodialysis unit.
Exercise Interventions:
Patients will be block randomized to one of the following 2 interventions:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •All adult (>18 years old) patients
- •Treated with hemodialysis for > 3 months
- •Hemoglobin > 100 g/L over the previous 2 months
- •Kt/V > 1.2 for last month and no history of shortened dialysis due to hemodialysis access issues or frequent alarming during dialysis due to poor access will be eligible for the study.
- •Study patients must also be likely able to complete 12 consecutive weeks of exercise (i.e. no travel, change of modality, elective surgery planned) and must be able to comprehend instructions in English.
排除标准
- •Acute medical illness in last month
- •Unstable hemodialysis with frequent hypotension over the past month
- •Active cardiovascular disease (stroke or acute coronary syndrome, unstable angina) in last 3 months
- •Lower extremity amputation with no prosthesis (inability to pedal a bike)
- •Spine compression fractures
- •Severe musculoskeletal pain at rest or with minimal activity
- •Inability to sit, stand or walk unassisted (walking devices such as cane will be allowed)
- •Shortness of breath at rest or with activities of daily living (NYHA Class IV)
- •Labile glycemic control with hypoglycaemic episodes > 1x/week.
结局指标
主要结局
Aerobic exercise capacity as measured by VO2 peak
时间窗: 3 and 6 months
physical function as measured by sit to stand to sit; sit and reach and 6 minute walk test
时间窗: 3 and 6 months
次要结局
- quality of life measured by SF36(3 and 6 months)
- dialysis adequacy as measured by ktV(3 and 6 months)