An Innovative Virtually Supervised Exercise for Dialysis Patients

Baylor College of Medicine

Status and phase: Completed; Phase 2

Conditions: Hemodialysis Complication; Chronic Kidney Failure; Diabetes

Treatments: Other: Non-technology foot and ankle exercise program; Other: Sensor-based interactive exercise (game-based exercise)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03076528

H-38522

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults of 50 years or older, who are undergoing hemodialysis process
• Patients in diabetes
• Ability to provide consent

Exclusion criteria

• 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Intervention with game-based exercise

Experimental group

Description:

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.

Treatment:

Other: Sensor-based interactive exercise (game-based exercise)

Non-technology foot and ankle exercise program

Active Comparator group

Description:

Subjects will be receiving non-technology foot and ankle exercise program during hemodialysis, approximately 30 minutes, twice per week and for 4 weeks.

Treatment:

Other: Non-technology foot and ankle exercise program