An Innovative Virtually Supervised Exercise for Dialysis Patients

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: January 6, 2019

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.

Arms, Groups and Cohorts

  • Experimental: 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.
  • Active Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Gait Speed change from Baseline to 4 weeks
    • Time Frame: Baseline and 4 weeks
    • walking ability is quantified by gait speed
  • Balance change from Baseline to 4 weeks quantified by body sway
    • Time Frame: Baseline and 4 weeks
    • Balance is quantified by body sway

Secondary Measures

  • Fear of Falling change from Baseline to 4 weeks using Fall Efficacy Scale International (FES-I) questionnaire
    • Time Frame: Baseline and 4 weeks
    • Measuring fear of falling using Fall Efficacy Scale International (FES-I) questionnaire
  • Depression change from Baseline to 4 weeks using Center of Epidemiologic Depression Scale (CES-D) questionnaire
    • Time Frame: Baseline to 4 weeks
    • Measuring depression using Center of Epidemiologic Depression Scale (CES-D) questionnaire
  • Change of Incident of falls
    • Time Frame: Baseline and 6 months
  • Change of Incidents of foot problems
    • Time Frame: Baseline and 6 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Baylor College of Medicine
  • Collaborator
    • Hamad Medical Corporation
  • Provider of Information About this Clinical Study
    • Principal Investigator: Bijan Najafi, PhD, Professor of Surgery – Baylor College of Medicine

Citations Reporting on Results

Zhou H, Al-Ali F, Rahemi H, Kulkarni N, Hamad A, Ibrahim R, Talal TK, Najafi B. Hemodialysis Impact on Motor Function beyond Aging and Diabetes-Objectively Assessing Gait and Balance by Wearable Technology. Sensors (Basel). 2018 Nov 14;18(11):3939. doi: 10.3390/s18113939.

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