Effect of Virtual Reality Exercise on Hemodialysis Patients: A Randomized Controlled Clinical Trial Research Protocol
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- Change of Intercellular Adhesion Molecule 1 (ICAM 1) (ng/ml)
研究概览
简要总结
Background. An increase in inflammatory biomarkers is associated with impaired kidney function and increased cardiovascular risk and mortality. Physical exercise has been shown to improve the functional capacity and inflammatory status of patients undergoing hemodialysis (HD) treatment, increasing their health-related quality of life. Virtual reality (VR) is an effective and safe tool to increase patient adherence to the exercise program, however, there are very few studies that analyze its effect on the functional capacity of patients with chronic kidney disease (CKD) in HD and none analyze its effect on the inflammatory state of these patients, which justifies the performance of this study.
Methods. Eighty patients with CKD on HD treatment will be randomly assigned into two groups, one of them will perform an intradialysis exercise program with non-immersive VR (intervention group; n=40), and the other will exercise with a static pedal (control group; n). =40). The functional capacity of the patients and their inflammatory and psychological status, as well as their exercise adherende, will be analyzed before and after exercise programs.
详细描述
Description of the intervention The exercise program will last for 12 weeks. Randomly, half of the patients will be instructed to - Control Group (CG): They will be instructed to exercise with a static pedal (control group) and the other half will be instructed to carry out the intradialysis non-immersive virtual reality exercise program.
- Intervention Group (IG): Will perform an intradialysis physical exercise program with non-immersive virtual reality during the first two hours of hemodialysis treatment (n = 40).
- Control Group (CG): They will exercise with a static pedal (n = 40). Exercise program The direction and supervision of the exercise programs will be the responsibility of the nursing staff of the Hemodialysis Unit and several physiotherapists of the Rehabilitation Unit of the General University Hospital of Alicante Doctor Balmis, the nursing staff being in charge of directing and supervising the intradialysis exercise program.
Prior to the beginning of the intervention, said personnel will receive exhaustive training on the characteristics of the exercise program and on how to carry it out in an optimal way. In this training they will be instructed on how to execute each of the exercises in the program with virtual reality.
During the two weeks prior to the intervention, a "first contact" period will be carried out, during which the nursing staff will implement the virtual reality intradialis exercise program as a test, so that they can familiarize themselves with the material necessary to exercise, as well as resolve any doubts that may arise. This trial period will be supervised by the physiotherapist in charge of giving them the training.
On the other hand, to improve adherence to exercise by patients and avoid losses throughout the program, all the staff in charge of directing and supervising the exercise will receive a training session by a psychologist specialized in managing barriers in special populations during exercise, with the aim of developing strategies to address these barriers during the intervention period.
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 (Participant, Outcomes Assessor)
盲法说明
The patients and the evaluator will be blind.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change of Intercellular Adhesion Molecule 1 (ICAM 1) (ng/ml)
时间窗: Change from Baseline ICAM 1 at 12 weeks
Inflammatoy marker
Change of Interleuquine 6 (IL-6) (pg/ml)
时间窗: Change from Baseline IL-6 at 12 weeks
Inflammatoy marker
Change of Tumoral Necrosis Factor-alpha (TNF-alpha) (pg/ml)
时间窗: Change from Baseline TNF-a at 12 weeks
Inflammatoy marker
Change of C Reactive Protein (CRP) (mg/L)
时间窗: Change from Baseline CRP at 12 weeks
Inflammatoy marker
Change of Vascular cell adhesion protein 1 (VCAM 1) (ng/ml)
时间窗: Change from Baseline VCAM 1 at 12 weeks
Inflammatoy marker
次要结局
- Assessment of the functional capacity of patients: Short Physical Performance Battery (SPPB)(baseline and up to 12 weeks)
- Assessment of the functional capacity of patients: 10 Sit To Stand Test (10 STS).(baseline and up to 12 weeks)
- Assessment of the functional capacity of patients: 60 Sit To Stand Test (60 STS).(baseline and up to 12 weeks)
- Psychological assessment of patients: Multidimensional Questionnaire of Adaptation to the Disease for Renal Patients on Dialysis(baseline and up to 12 weeks)
- Assessment of the functional capacity of patients: 6 minute walk test (6MWT)(baseline and up to 12 weeks)
研究者
Érika Meléndez Oliva
Principal Investigator
Universidad Miguel Hernandez de Elche