The Effect of 25-hydroxyvitamin D Supplementation and a Structured Exercise Program on Exercise Capacity and Quality of Life in Dialysis Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Exercise capacity - modified shuttle walk test
研究概览
简要总结
This study aims to examine the effect of 25 hydroxyvitamin D supplementation and a structured exercise program on the exercise capacity and quality of life of haemodialysis patients with 25 hydroxyvitamin D insufficiency.
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
- 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
- •Stable on dialysis for at least 3 months
- •Able to obtain informed consent
- •Medically stable
- •Dialysis adequacy at target for small solute clearance (ie Kt/V>1.2 or Urea reduction ratio>65%)
- •Serum 25-hydroxyvitamin D levels less than 75nmol/L at baseline
排除标准
- •Limb Amputation
- •Impaired cognition
- •Impaired vision
- •Haemoglobin concentration < 110g/L
- •Change in Erythropoiesis stimulating agent dose over the last 2 months
- •Unable or unwilling to comply with exercise program
研究组 & 干预措施
Structured exercise program
Participants will be randomised at 3 months into either this group or the comparator of usual exercise.
干预措施: Structured Exercise program (Other)
Vitamin D
Cholecalciferol 2000U per day will be given to all participants for the duration of the study
干预措施: Cholecalciferol (25-Hydroxyvitamin D) (Drug)
Usual exercise
Participants randomised to this arm, at 3 months, will continue on their usual exercise routine
干预措施: Usual exercise (Other)
结局指标
主要结局
Exercise capacity - modified shuttle walk test
时间窗: Basesline, 3 & 6 months
次要结局
- Quality of life with KDQOL(Baseline, 3 & 6 months)
- Quadriceps Strength(Baseline, 3 & 6 months)
- Serum phosphate(baselibe, 3 & 6 months)
- Feeling thermometer(Baseline, 3 & 6 months)
- Timed up and go(baseline, 3 & 6 months)
- Falls(continuous)
- Pulse wave velocity(baseline, 3 & 6 months)
- Bioimpedance(Baseline, 3 & 6 months)
研究者
Neil Boudville
Associate Professor
Sir Charles Gairdner Hospital