An Innovative Virtually Supervised Exercise for Dialysis Patients

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Qatar
  • Doha, Qatar
    • Hamad Medical Coorporation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Collaborators: Hamad Medical Corporation; Qatar National Research Foundation (QNRF), Award # NPRP 7-1595-3-405

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2016
• Primary Completion (Actual): January 6, 2019
• Study Completion (Actual): February 6, 2019

Study Registration Dates

• First Submitted: March 7, 2017
• First Submitted That Met QC Criteria: March 9, 2017
• First Posted (Actual): March 10, 2017

Study Record Updates

• Last Update Posted (Actual): May 6, 2019
• Last Update Submitted That Met QC Criteria: May 2, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: exercise; hemodialysis; balance; exergame
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: H-38522

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Only de-identified data and associated results will be published in peer-review papers or scientific abstracts.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No