An Innovative Virtually Supervised Exercise for Dialysis Patients

Study Overview
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Brief Summary
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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.

Official Title
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An Innovative Virtually Supervised Exercise for Dialysis Patients

Conditions
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Diabetes, Chronic Kidney Failure, Hemodialysis Complication

Intervention / Treatment
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* Other: Sensor-based interactive exercise (game-based exercise)
* Other: Non-technology foot and ankle exercise program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention with game-based exercise<br>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. | Other: Sensor-based interactive exercise (game-based exercise)<br>* 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<br>|
| Active Comparator: Non-technology foot and ankle exercise program<br>Subjects will be receiving non-technology foot and ankle exercise program during hemodialysis, approximately 30 minutes, twice per week and for 4 weeks. | Other: Non-technology foot and ankle exercise program<br>* Subjects are asked to perform non-technology based foot and ankle exercises, which include plantar flexion and extension.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait Speed change from Baseline to 4 weeks | walking ability is quantified by gait speed | Baseline and 4 weeks | 
| Balance change from Baseline to 4 weeks quantified by body sway | Balance is quantified by body sway | Baseline and 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fear of Falling change from Baseline to 4 weeks using Fall Efficacy Scale International (FES-I) questionnaire | Measuring fear of falling 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 | Measuring depression 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, exergame, hemodialysis, balance