An Innovative Virtually Supervised Exercise for Dialysis Patients

Phase 2

Completed

• Conditions: Hemodialysis Complication; Diabetes; Chronic Kidney Failure
• Interventions: Other: Non-technology foot and ankle exercise program; Other: Sensor-based interactive exercise (game-based exercise)

• Registration Number: NCT03076528
• Lead Sponsor: Baylor College of Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-06
• Study First Submitted: 2017-03-07
• Study First Submitted QC: 2017-03-09
• Study First Posted: 2017-03-10
• Primary Completion: 2019-01-06
• Study Completion: 2019-02-06
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-02
• Last Update Posted: 2019-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-technology foot and ankle exercise program	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.
Intervention with game-based exercise	Sensor-based interactive exercise (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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hamad Medical Coorporation; 🇶🇦 Doha, Qatar