An Innovative Virtually Supervised Exercise for Dialysis Patients

Diabetes Clinical Trial

Official title:

An Innovative Virtually Supervised Exercise for Dialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03076528
• Other study ID #: H-38522
• Status: Completed
• Phase: Phase 2
• Start date: November 6, 2016
• Est. completion date: February 6, 2019

Study information

• Verified date: May 2019
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 6, 2019
• Est. primary completion date: January 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Failure
• Diabetes
• Hemodialysis Complication
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

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
• 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.

Locations

Country	Name	City	State
Qatar	Hamad Medical Coorporation	Doha

Sponsors (3)

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

Country where clinical trial is conducted

Qatar, 

References & 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). pii: E3939. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait Speed change from Baseline to 4 weeks	walking ability is quantified by gait speed	Baseline and 4 weeks
Primary	Balance change from Baseline to 4 weeks quantified by body sway	Balance is quantified by body sway	Baseline and 4 weeks
Secondary	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
Secondary	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
Secondary	Change of Incident of falls		Baseline and 6 months
Secondary	Change of Incidents of foot problems		Baseline and 6 months