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Completed

NCT Number: NCT03076528

An Innovative Virtually Supervised Exercise for Dialysis Patients

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.

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Key information

Conditions

Diabetes Behavior Chronic Disease Chronic Kidney Failure Diabetes Mellitus Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Hemodialysis Complication Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hamad Medical Coorporation

Doha, Qatar

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • Hamad Medical Corporation
  • Qatar National Research Fund

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 10, 2017
Registry last updated
May 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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