Home-based vs Intradialysis Exercise Program Guided by Nursing Staff
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 13
- 主要终点
- Change from baseline short physical performance battery at 16 weeks
研究概览
简要总结
Participants will be randomized either to home-based exercise or to intradialysis exercise guided by nurses of the renal unit. The programs will last 16 weeks. The intradialysis exercise consists of combined aerobic and resistance training exercise. The home-based exercise consists of resistance exercise and walking.
详细描述
During 16 weeks one group will follow an intradialysis exercise program. The exercise program consists of strengthening exercises for lower limbs and for the upper limb free of fistula. The exercise program includes isotonic exercises for quadriceps, triceps surae, psoas, glutei, and brachial biceps; and isometric exercises for hip adductors and hamstrings. Elastic bands will be used to apply resistance. Progression will be achieved by increasing from 1 set of 10 repetitions until 3 sets of 15 repetitions. This first part of the exercise session will last no more than 30 minutes. The program will also include aerobic exercise (cycling) for up to 30 minutes. Intensity will adapted through the duration of the study so that the participant feel the exercise from hard to somewhat hard (13 to 15 at the rate of perceived exertion 6 to 20). Time and resistance will be adapted progressively. After an initial training period by a physiotherapist, the nursing staff will be responsible for monitoring and implementing the program.
The other group will follow a home-based program. A booklet with resistance exercise and recommendation of walking between exercises will be provided. An initial training phase will be applied by the physiotherapists from the rehabilitation department.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
A team of assessors, different from the researchers implementing the exercise, will record all dependent variables. A blind researcher will randomize participants
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
- •Patients on hemodialysis medically stable, be able to walk at least a few steps, even if you need walking aids like canes or a walker. Life expectancy greater than 6 months
排除标准
- •Myocardial infarction in the previous 6 weeks
- •Angina unstable on exercise or at rest
- •Brain injury derived from a cardiovascular problem. Cerebral vascular disease such as stroke in the last 6 months or with relevant sequelae in lower limb mobility presenting hemiparesia.
- •Life expectancy less than 6 months
- •Cognitive impairment
- •Language barriers
结局指标
主要结局
Change from baseline short physical performance battery at 16 weeks
时间窗: Baseline, 16 weeks
Score achieved at the battery that includes balance tests (4 points), sit to stand to sit 5 (4 points) and and gait speed (4 points). The total score is calculated , from 1 to 12, being 12 the highest functional score
Change from baseline gait speed at 16 weeks
时间窗: Baseline, 16 weeks
Speed to cover 4 meters, in meters/second
次要结局
- Change from baseline sit to stand 60 test at 16 weeks(Baseline, 16 weeks)
- Change from baseline one-leg heel rise test at 16 weeks(Baseline, 16 weeks)
- Change from baseline sit to stand 10 test at 16 weeks(Baseline, 16 weeks)
- Change from baseline timed up and go test at 16 weeks(Baseline, 16 weeks)
- Change from baseline handgrip strength at 16 weeks(Baseline, 16 weeks)
- Change from baseline one-leg standing test at 16 weeks(Baseline, 16 weeks)
- Change from baseline Physical activity level at 16 weeks(Baseline, 16 weeks)
- Adherence, as number of sessions performed /number of sessions offered(16 weeks)
- Change from baseline 6 minutes walk test at 16 weeks(Baseline, 16 weeks)
- Change from baseline Health related quality of life at 16 weeks(Baseline, 16 weeks)
研究者
Eva Segura Ortí
Professor
Cardenal Herrera University