An Innovative Virtually Supervised Exercise for Dialysis Patients

NCT ID: NCT03076528

Last Updated: 2019-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-06
• Study Completion Date: 2019-02-06

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Sensor-based interactive exercise (game-based exercise)

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Non-technology foot and ankle exercise program

Intervention Type: OTHER

Subjects are asked to perform non-technology based foot and ankle exercises, which include plantar flexion and extension.

Interventions

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

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hamad Medical Corporation

INDUSTRY

Sponsor Role: collaborator

Qatar National Research Foundation (QNRF), Award # NPRP 7-1595-3-405

UNKNOWN

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Bijan Najafi, PhD

Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hamad Medical Coorporation

Doha, , Qatar

Countries

Qatar

References

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.

Reference Type: RESULT

PMID: 30441843 (View on PubMed)

Other Identifiers

H-38522

Identifier Type: -

Identifier Source: org_study_id