An Innovative Virtually Supervised Exercise for Dialysis Patients
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|ClinicalTrials.gov Identifier: NCT03076528|
Recruitment Status : Completed
First Posted : March 10, 2017
Last Update Posted : May 6, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Chronic Kidney Failure Hemodialysis Complication||Other: Sensor-based interactive exercise (game-based exercise) Other: Non-technology foot and ankle exercise program||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||An Innovative Virtually Supervised Exercise for Dialysis Patients|
|Actual Study Start Date :||November 6, 2016|
|Actual Primary Completion Date :||January 6, 2019|
|Actual Study Completion Date :||February 6, 2019|
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.
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
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.
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.
- 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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03076528
|Hamad Medical Coorporation|