Clinical trial NCT03076528: An Innovative Virtually Supervised Exercise for Dialysis Patients
Official title: An Innovative Virtually Supervised Exercise for Dialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes
Chronic Kidney Failure
Hemodialysis Complication
Keywords: exercise
exergame
hemodialysis
balance
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Hamad Medical Corporation
name: Qatar National Research Foundation (QNRF), Award # NPRP 7-1595-3-405
First posted: 2017-03-10
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Gait Speed change from Baseline to 4 weeks
timeFrame: Baseline and 4 weeks
measure: Balance change from Baseline to 4 weeks quantified by body sway
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: Fear of Falling change from Baseline to 4 weeks using Fall Efficacy Scale International (FES-I) questionnaire
timeFrame: Baseline and 4 weeks
measure: Depression change from Baseline to 4 weeks using Center of Epidemiologic Depression Scale (CES-D) questionnaire
timeFrame: Baseline to 4 weeks
measure: Change of Incident of falls
timeFrame: Baseline and 6 months
measure: Change of Incidents of foot problems
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: Hamad Medical Coorporation
Study officials:
References:
citation: 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.