NCT03076528

An Innovative Virtually Supervised Exercise for Dialysis Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Diabetes
• Chronic Kidney Failure
• Hemodialysis Complication

Interventions

Type	Name	Description
OTHER	Sensor-based interactive exercise (game-based exercise)	This intervention includes interactive game-based lower extremity training including repetitive ankle movements in multiple directions. Wearable sensors will provide real-time feedback from foot and ankle position and allow perception of motor-errors during each motor-action
OTHER	Non-technology foot and ankle exercise program	Subjects are asked to perform non-technology based foot and ankle exercises, which include plantar flexion and extension.

Timeline

• Start date: 2016-11-06
• Primary completion: 2019-01-06
• Completion: 2019-02-06
• First posted: 2017-03-10
• Last updated: 2019-05-06

Locations

1 site across 1 country: Qatar