An Innovative Virtually Supervised Exercise for Dialysis Patients

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

• Hemodialysis Complication
• Diabetes
• Chronic Kidney Failure

Interventions

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.

Sponsors & Collaborators

• Hamad Medical Corporation

  collaborator INDUSTRY

• Qatar National Research Foundation (QNRF), Award # NPRP 7-1595-3-405

  collaborator UNKNOWN

• Baylor College of Medicine

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-11-06

Primary Completion

2019-01-06

Completion

2019-02-06

Countries

• Qatar

Study Locations