An Innovative Virtually Supervised Exercise for Dialysis Patients
Primary Purpose
Diabetes, Chronic Kidney Failure, Hemodialysis Complication
Status
Completed
Phase
Phase 2
Locations
Qatar
Study Type
Interventional
Intervention
Sensor-based interactive exercise (game-based exercise)
Non-technology foot and ankle exercise program
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetes focused on measuring exercise, exergame, hemodialysis, balance
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
Sites / Locations
- Hamad Medical Coorporation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention with game-based exercise
Non-technology foot and ankle exercise program
Arm Description
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.
Subjects will be receiving non-technology foot and ankle exercise program during hemodialysis, approximately 30 minutes, twice per week and for 4 weeks.
Outcomes
Primary Outcome Measures
Gait Speed change from Baseline to 4 weeks
walking ability is quantified by gait speed
Balance change from Baseline to 4 weeks quantified by body sway
Balance is quantified by body sway
Secondary Outcome Measures
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
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
Change of Incident of falls
Change of Incidents of foot problems
Full Information
NCT ID
NCT03076528
First Posted
March 7, 2017
Last Updated
May 2, 2019
Sponsor
Baylor College of Medicine
Collaborators
Hamad Medical Corporation, Qatar National Research Foundation (QNRF), Award # NPRP 7-1595-3-405
1. Study Identification
Unique Protocol Identification Number
NCT03076528
Brief Title
An Innovative Virtually Supervised Exercise for Dialysis Patients
Official Title
An Innovative Virtually Supervised Exercise for Dialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
November 6, 2016 (Actual)
Primary Completion Date
January 6, 2019 (Actual)
Study Completion Date
February 6, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
Hamad Medical Corporation, Qatar National Research Foundation (QNRF), Award # NPRP 7-1595-3-405
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Chronic Kidney Failure, Hemodialysis Complication
Keywords
exercise, exergame, hemodialysis, balance
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention with game-based exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-technology foot and ankle exercise program
Arm Type
Active Comparator
Arm Description
Subjects will be receiving non-technology foot and ankle exercise program during hemodialysis, approximately 30 minutes, twice per week and for 4 weeks.
Intervention Type
Other
Intervention Name(s)
Sensor-based interactive exercise (game-based exercise)
Intervention Description
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 Type
Other
Intervention Name(s)
Non-technology foot and ankle exercise program
Intervention Description
Subjects are asked to perform non-technology based foot and ankle exercises, which include plantar flexion and extension.
Primary Outcome Measure Information:
Title
Gait Speed change from Baseline to 4 weeks
Description
walking ability is quantified by gait speed
Time Frame
Baseline and 4 weeks
Title
Balance change from Baseline to 4 weeks quantified by body sway
Description
Balance is quantified by body sway
Time Frame
Baseline and 4 weeks
Secondary Outcome Measure Information:
Title
Fear of Falling change from Baseline to 4 weeks using Fall Efficacy Scale International (FES-I) questionnaire
Description
Measuring fear of falling using Fall Efficacy Scale International (FES-I) questionnaire
Time Frame
Baseline and 4 weeks
Title
Depression change from Baseline to 4 weeks using Center of Epidemiologic Depression Scale (CES-D) questionnaire
Description
Measuring depression using Center of Epidemiologic Depression Scale (CES-D) questionnaire
Time Frame
Baseline to 4 weeks
Title
Change of Incident of falls
Time Frame
Baseline and 6 months
Title
Change of Incidents of foot problems
Time Frame
Baseline and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Hamad Medical Coorporation
City
Doha
Country
Qatar
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Only de-identified data and associated results will be published in peer-review papers or scientific abstracts.
Citations:
PubMed Identifier
30441843
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.
Results Reference
result
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An Innovative Virtually Supervised Exercise for Dialysis Patients
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