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| Name | Class |
|---|---|
| Hamad Medical Corporation | INDUSTRY |
| Qatar National Research Fund | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention with game-based exercise | Experimental | 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. |
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| Non-technology foot and ankle exercise program | Active Comparator | Subjects will be receiving non-technology foot and ankle exercise program during hemodialysis, approximately 30 minutes, twice per week and for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sensor-based interactive exercise (game-based exercise) | Other | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamad Medical Coorporation | Doha | Qatar |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30441843 | Result | 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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Only de-identified data and associated results will be published in peer-review papers or scientific abstracts.
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D007676 | Kidney Failure, Chronic |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Non-technology foot and ankle exercise program | Other | Subjects are asked to perform non-technology based foot and ankle exercises, which include plantar flexion and extension. |
|
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 |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |