An Innovative Virtually Supervised Exercise for Dialysis Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03076528
• Date of registration: 07/03/2017
• Prospective Registration: No
• Primary sponsor: Baylor College of Medicine
• Public title: An Innovative Virtually Supervised Exercise for Dialysis Patients
• Scientific title: An Innovative Virtually Supervised Exercise for Dialysis Patients
• Date of first enrolment: November 6, 2016
• Target sample size: 100
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03076528
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Double (Participant, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Qatar

Key inclusion & exclusion 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



Age minimum: 50 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hemodialysis Complication

Chronic Kidney Failure

Diabetes

Intervention(s)

Other: Non-technology foot and ankle exercise program

Other: Sensor-based interactive exercise (game-based exercise)

Primary Outcome(s)

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

Gait Speed change from Baseline to 4 weeks [Time Frame: Baseline and 4 weeks]

Secondary Outcome(s)

Fear of Falling change from Baseline to 4 weeks using Fall Efficacy Scale International (FES-I) questionnaire [Time Frame: Baseline and 4 weeks]

Change of Incidents of foot problems [Time Frame: Baseline and 6 months]

Change of Incident of falls [Time Frame: Baseline and 6 months]

Depression change from Baseline to 4 weeks using Center of Epidemiologic Depression Scale (CES-D) questionnaire [Time Frame: Baseline to 4 weeks]

Secondary ID(s)

H-38522

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

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

Hamad Medical Corporation