Comparison of Aerobic Exercise, Strength Training, or Its Combination in Hemodialysis Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- change in walking speed over 20 weeks
研究概览
简要总结
Study Hypothesis: The combination of aerobic and resistance exercise training will improve walking speed compared to either individual intervention.
Brief Summary:
Sixty hemodialysis participants who meet inclusion and exclusion criteria will be randomized to 20 weeks of supervised exercise, using either: (i) on-dialysis aerobic exercise using a bike ergometer; (ii) pre-dialysis leg strength training using weights; or (iii) both. The primary outcome is walking speed over 4-metres. Secondary outcomes will include:
(i) short physical performance battery; (ii) health-related quality of life [EuroQOL-5D-5L]; (iii) Dialysis recovery time; (iv) Nottingham extended activities of daily living (EADL) index; (v) Leg strength; (vi) body composition and anthropometry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •At least 18 years of age
- •On hemodialysis minimum of 3 times per week
- •On hemodialysis > 3 consecutive months
排除标准
- •Inability to provide consent
- •Inability to walk 4-metres
- •Chest pain with exertion or myocardial infarction in past 6-months
- •Pre-dialysis systolic blood pressure > 200 mm Hg or diastolic BP > 100 mm Hg in past 2-weeks
- •Functional or cardiorespiratory limitations preventing use of cycle ergometer for at least five-minutes or the ability to perform single maximum rep with each of resistance exercises described
- •Joint replacement or lower extremity fracture in previous 6-months
- •Severe cognitive impairment
- •Currently using corticosteroids >5 mg/day
- •Pre-dialysis serum potassium in previous month less than 3.5 or greater than 6.0 mmol/L.
- •Attending nephrologist feels exercise is medically contraindicated
- •Scheduled living related kidney transplant in next 6 months
结局指标
主要结局
change in walking speed over 20 weeks
时间窗: 10 and 20 weeks
repeated measures analysis
次要结局
- change in short physical performance battery over 20 weeks(10 and 20 weeks)
- change in body anthropometry and composition over 20 weeks.(10 and 20 weeks)
- change in EuroQOL-5D-5L over 20 weeks(10 and 20 weeks)
- change in Nottingham extended activities of daily living index over 20 weeks(10 and 20 weeks)
- change in dialysis recovery time over 20 weeks(10 and 20 weeks)
- death(continuous over 20 weeks)
- change in inflammation measures over 20 weeks(10 and 20 weeks)
- hospitalization(continuous over 20 weeks)
研究者
Scott Brimble
Staff Nephrologist/Associate Professor of Medicine
St. Joseph's Healthcare Hamilton