Virtual Reality Exercise Intradialysis: Tolerance and Dialysis Dose Effects During the Last vs. First Part of the Hemodialysis Session
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Number of hypotension episodes
研究概览
简要总结
The main objective of this investigation is to assess if an intradialysis virtual reality exercise program during the last two hours of the hemodialysis session results in greater hemodynamic stability than exercise performed during the first two hours of the hemodialysis session.
The secondary aims are to assess the impact of intradialysis virtual reality exercise during the last two hours of the hemodialysis session on dialysis efficacy, postdialysis molecules rebound, adherence to exercise, functional capacity, physical activity level, health-related quality of life, cognitive function, morbidity, frailty and dependency. We will also analyze the reliability of muscle strength assessment of lower limb muscles with a handheld dynamometer during hemodialysis.
详细描述
Participants will be randomized into one of two groups. The first group will perform a virtual reality exercise during the first two hours of the hemodialysis session. The second group will perform a virtual reality exercise during the last two hours of the hemodialysis session. The exercise program will last for 9 months.
The virtual reality exercise will undertake up to 30 minutes of exercise. After warming up, participants will play to an adapted 'treasure hunt' game. Their legs movements will be the players projected into an individual tv that will give them feedback regarding their achievements. The aim of the game will be to achieve the higher possible score. They will move their legs to pick up coins and to avoid bombs. An adapted Kinect technology will be used for game development. The exercise session will end-up with a cool-down period that will include simple lower limb stretching exercises. Two more games will be introduced progressively for patients not to get bored, 'Air Hockey' and 'Simon'.
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
- •At least 3 months in hemodialysis treatment
- •Clinically stable
排除标准
- •Recent cardiac events (less than 3 months)
- •Unable to exercise
结局指标
主要结局
Number of hypotension episodes
时间窗: 12 Months
Number of hypotension episodes, including hypotension that requires treatment, hypertensive crisis and acute arrhythmias
次要结局
- Adherence, as number of sessions performed /number of sessions offered(Baseline, 3 Months, 6 months and 12 months)
- Change from baseline handgrip at 3 months, 6 months, and 12 months(Baseline, 3 Months, 6 months and 12 months)
- Change from baseline postdialysis rebound urea, creatinine, phosphorus and potassium at 3 months(Baseline and 3 months)
- Change from baseline short physical performance battery at 3 months, 6 months, and 12 months(Baseline, 3 Months, 6 months and 12 months)
- Change from baseline one-leg heel rise test at 3 months, 6 months, and 12 months(Baseline, 3 Months, 6 months and 12 months)
- Change from baseline timed up and go at 3 months, 6 months, and 12 months(Baseline, 3 Months, 6 months and 12 months)
- Change from baseline dialysis dose at 3 months, 6 months, and 12 months(Baseline, 3 Months, 6 months and 12 months)
- Change from baseline gait speed at 3 months, 6 months, and 12 months(Baseline, 3 Months, 6 months and 12 months)
- Change from baseline lower limb muscle strength at 3 months, 6 months, and 12 months(Baseline, 3 Months, 6 months and 12 months)
- Change from baseline one-leg standing test at 3 months, 6 months, and 12 months(Baseline, 3 Months, 6 months and 12 months)
- Change from baseline Cognitive function at 3 months, 6 months, and 12 months(Baseline, 3 Months, 6 months and 12 months)
- Change from baseline frailty (slowness; weakness; weight loss/malnutrition;low physical activity; exhaustion) at 3 months, 6 months, and 12 months(Baseline, 3 Months, 6 months and 12 months)
- Change from baseline sit to stand 10 test at 3 months, 6 months, and 12 months(Baseline, 3 Months, 6 months and 12 months)
- Change from baseline sit to stand 60 at 3 months, 6 months, and 12 months(Baseline, 3 Months, 6 months and 12 months)
- Change from baseline 6 minutes walk test at 3 months, 6 months, and 12 months(Baseline, 3 Months, 6 months and 12 months)
- Change from baseline Physical activity level at 3 months, 6 months, and 12 months(Baseline, 3 Months, 6 months and 12 months)
- Change from baseline disability by Barthel Index at 3 months, 6 months, and 12 months(Baseline, 3 Months, 6 months and 12 months)
- Change from baseline Health related quality of life at 3 months, 6 months, and 12 months(Baseline, 3 Months, 6 months and 12 months)
研究者
Eva Segura Ortí
Professor
Cardenal Herrera University