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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
Sponsor:
Collaborators:
Hamad Medical Corporation
Qatar National Research Foundation (QNRF), Award # NPRP 7-1595-3-405
Information provided by (Responsible Party):
Bijan Najafi, PhD, 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.


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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Gait Speed change from Baseline to 4 weeks [ Time Frame: Baseline and 4 weeks ]
    walking ability is quantified by gait speed

  2. Balance change from Baseline to 4 weeks quantified by body sway [ Time Frame: Baseline and 4 weeks ]
    Balance is quantified by body sway


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Change of Incident of falls [ Time Frame: Baseline and 6 months ]
  4. Change of Incidents of foot problems [ Time Frame: Baseline and 6 months ]


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Qatar
Hamad Medical Coorporation
Doha, Qatar
Sponsors and Collaborators
Baylor College of Medicine
Hamad Medical Corporation
Qatar National Research Foundation (QNRF), Award # NPRP 7-1595-3-405

Publications of Results:
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Responsible Party: Bijan Najafi, PhD, Professor of Surgery, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT03076528     History of Changes
Other Study ID Numbers: H-38522
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Only de-identified data and associated results will be published in peer-review papers or scientific abstracts.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bijan Najafi, PhD, Baylor College of Medicine:
exercise
exergame
hemodialysis
balance
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic