An Innovative Virtually Supervised Exercise for Dialysis Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Gait Speed change from Baseline to 4 weeks
研究概览
简要总结
Among patients with diabetes 35% suffer from chronic renal disease and may require dialysis or kidney replacement over time. Furthermore, in diabetics with end stage renal disease (ESRD) that require dialysis, the risk of foot complications and amputation is even more common, expensive, and devastating. Interestingly, even though incidence of foot ulcers in patients with dialysis has been reported to be same as with patients with history of foot ulcers; dialysis patients have significantly higher rate of foot amputation.
The goal of this research is to incorporate an innovative virtually supervised non-weight bearing exercise in patients undergoing dialysis to reduce risk of fall and foot ulceration by enhancing lower extremity blood flow, joint perception and joint mobility.
Diabetic patients on hemodialysis at Hamad Medical Company will be recruited and will be randomized to either intervention (IG) or control (CG) group and followed for 6 months. The intervention group will take part in a 4-week non-weight bearing exercise program twice per week at the hemodialysis clinic under the supervision of a qualified research staff member. This intervention includes interactive game-based exercises including repetitive ankle and foot movements. Wearable sensors will provide real-time visual/auditory feedback from foot and ankle position and allowed perception of motor-errors during each motor-action. The control group will be instructed to complete a supervised foot and ankle exercise without using sensor technology. Changes in balance, gait, and physical activity, incidence of foot problems will be compared pre- and post-intervention. In addition, the incident of falls, foot ulcers, and limb amputation up to 6 months post intervention will be documented. Investigators hypothesize that patients receiving sensor-based exercises will benefit more compared to group receiving conventional non-technology training in terms of improving functional performance and reducing incidence of foot problems, falls, and limb amputation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults of 50 years or older, who are undergoing hemodialysis process
- •Patients in diabetes
- •Ability to provide consent
排除标准
- •Non-ambulatory patients (unable to walk independently a distance of 20m with or without existence)
- •Active foot ulcer
- •Major foot amputation
- •Charcot neuroarthropathy
- •Major hearing/vision impaired
- •Any patient with changes in psychotropic or sleep medications in the last 6 weeks
- •Patients concurrently participating in another exercise training
- •Patients with any clinically significant medical or psychiatric condition, or laboratory abnormality
研究组 & 干预措施
Intervention with game-based exercise
Subjects will be receiving sensor-based interactive ankle & foot exercise program (game-based exercise) during hemo-dialysis, approximately 30 minutes, twice per week and for 4 weeks.
干预措施: Sensor-based interactive exercise (game-based exercise) (Other)
Non-technology foot and ankle exercise program
Subjects will be receiving non-technology foot and ankle exercise program during hemodialysis, approximately 30 minutes, twice per week and for 4 weeks.
干预措施: Non-technology foot and ankle exercise program (Other)
结局指标
主要结局
Gait Speed change from Baseline to 4 weeks
时间窗: Baseline and 4 weeks
walking ability is quantified by gait speed
Balance change from Baseline to 4 weeks quantified by body sway
时间窗: Baseline and 4 weeks
Balance is quantified by body sway
次要结局
- Fear of Falling change from Baseline to 4 weeks using Fall Efficacy Scale International (FES-I) questionnaire(Baseline and 4 weeks)
- Depression change from Baseline to 4 weeks using Center of Epidemiologic Depression Scale (CES-D) questionnaire(Baseline to 4 weeks)
- Change of Incident of falls(Baseline and 6 months)
- Change of Incidents of foot problems(Baseline and 6 months)
研究者
Bijan Najafi, PhD
Professor of Surgery
Baylor College of Medicine