Effects of Home-based Exercise in Advanced Chronic Kidney Disease and End-stage Renal Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Change from baseline sit to stand 10 test at 12 and 24 weeks
研究概览
简要总结
A home-based exercise program will be implemented in three different groups of participants: advanced chronic kidney disease, end-stage renal disease in substitutive treatment hemodialysis or peritoneal dialysis. Participants will be evaluated before the program, after 3 months and after 6 months from the starting of the program. During the first 3 months the researcher will phone them weekly to reinforce the exercise habit, and during the last three months, there will be no reinforcement. Assessment will include strength, functional capacity, health-related quality of life and depressive symptoms.
详细描述
Three groups of participants (advanced chronic disease not yet in substitutive treatment, end-stage renal disease patients in hemodialysis and end-stage renal disease patients in peritoneal dialysis) will enter the study. The intervention will consist of a home-based exercise program. They will be provided with a booklet and the researcher will explain personally each of the exercises to the participants. Progression will be encouraged so that the participants should find the sessions 'somewhat hard' according to the rate of perceived exertion. Reinforcement will be high during the first 3 months (weekly phone calls, visits to the nephrology department) and none during the last 3 months. Assessment will be undertaken at three-time points: baseline, after 3 months of high reinforcement and after 3 more months of no reinforcement at all.
Assessment will include strength, functional capacity, health-related quality of life, cognitive state and depressive symptoms.
The aim of the study is to assess the effectiveness of home-based exercise to improve strength, physical function, health-related quality of life, cognitive state and depressive symptoms in advanced chronic kidney disease and end-stage renal disease (hemodialysis and peritoneal dialysis). We also aim at describing all these variables in the three different groups of patients. Adherence and satisfaction with the exercise program will be recorded at the end of the study.
Additionally, interobserver reliability will be calculated, so as reliability intraobserver in different measurement conditions (dialysis vs non-dialysis days).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •At least 3 months in hemodialysis treatment
- •Clinically stable
排除标准
- •Recent cardiac events (less than 3 months)
- •Unable to exercise
研究组 & 干预措施
Home-based exercise
Home-based intervention in the advanced chronic kidney disease group, hemodialysis or peritoneal dialysis group
干预措施: Home-based exercise (Other)
结局指标
主要结局
Change from baseline sit to stand 10 test at 12 and 24 weeks
时间窗: Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks
Sit to stand to sit test 10, time to perform 10 repetitions
次要结局
- Change from baseline Handgrip strength (dynamometry) at 12 and 24 weeks(Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks)
- Change from baseline Six-minute walking test at 12 and 24 weeks(Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks)
- Change from baseline OLHR at 12 and 24 weeks(Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks)
- Change from baseline STS-60 at 12 and 24 weeks(Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks)
- Change from baseline SPPB at 12 and 24 weeks(Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks)
- Change from baseline TUG at 12 and 24 weeks(Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks)
- Change from baseline Health-related quality of life measured through the Euro quality of life questionnaire, 5 dimensions, at 12 and 24 weeks(Baseline,12 weeks, 24 weeks)
- Change from baseline Beck depression inventory at 12 and 24 weeks(Baseline,12 weeks, 24 weeks)
- Change from baseline OLST at 12 and 24 weeks(Baseline,1 week, non-dialysis day baseline,12 weeks, 24 weeks)
- Change from baseline Physical Activity Scale for the elderly at 12 and 24 weeks(Baseline,12 weeks, 24 weeks)
- Change from baseline Albumin at 12 and 24 weeks(Baseline,12 weeks, 24 weeks)
- Change from baseline Human activity profile at 12 and 24 weeks Human activity profile(Baseline,12 weeks, 24 weeks)
- Adherence(12 weeks, 24 weeks)
研究者
Eva Segura Ortí
Professor
Cardenal Herrera University