An Innovative Virtually Supervised Exercise for Dialysis Patients

NCT03076528 | Completed Phase 2

• 1 other identifier: H-38522
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Chronic Kidney Failure; Hemodialysis Complication

Keywords

exercise; exergame; hemodialysis; balance

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Fear of Falling change from Baseline to 4 weeks 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

  Baseline to 4 weeks

• Change of Incident of falls

  Baseline and 6 months

• Change of Incidents of foot problems

  Baseline and 6 months

Study Arms (2)

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.

Other: Sensor-based interactive exercise (game-based exercise)

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.

Other: Non-technology foot and ankle exercise program

Interventions

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

Intervention with game-based exercise

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.

Non-technology foot and ankle exercise program

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults of 50 years or older, who are undergoing hemodialysis process
• Patients in diabetes
• Ability to provide consent

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Hamad Medical Coorporation

Doha, Qatar

Location

Related Publications (1)

• 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.

  PMID: 30441843 RESULT

MeSH Terms

Conditions

Diabetes Mellitus; Kidney Failure, Chronic; Motor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: March 10, 2017
• Study Start: November 6, 2016
• Primary Completion: January 6, 2019
• Study Completion: February 6, 2019
• Last Updated: May 6, 2019

Record last verified: 2019-05

Locations

QA (1)