The Effect of Intradialytic Eye Exercise in Hemodialysis Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPardis Specialized Wellness Institute
About this trial
This pilot randomized trial will evaluate whether a structured intradialytic eye-exercise program can be delivered safely and consistently during maintenance hemodialysis and whether it shows preliminary promise for improving physical function, balance, and fall-related concern. The study is needed because hemodialysis patients commonly experience impaired physical performance, reduced balance, and fear of falling, and these problems are associated with higher fall risk; at the same time, supervised exercise during dialysis is increasingly viewed as a practical way to reach this medically complex and often sedentary population. Eye-movement and gaze-stability training has also shown benefit for balance- and fall-related outcomes in older adults and stroke survivors, but its feasibility and potential value during dialysis sessions remain uncertain.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults ≥18 years receiving maintenance in-center hemodialysis
Clinically stable for brief seated intradialytic intervention
Able to understand and follow eye-exercise instructions
Able to provide informed consent
Disqualifiers
Unstable cardiac conditions (e.g., unstable angina, recent myocardial infarction, decompensated heart failure, uncontrolled arrhythmia)
Active infection or acute medical illness
Hemodynamic instability
Significant cognitive or communication impairment preventing instruction-following
Trial design
Design model
Parallel
Treatments tested in this trial
Intradialytic Eye Exercise
BehavioralThe participants in the study group will perform the eye exercise program while seated during hemodialysis treatment. The exercises will be administered face-to-face in the dialysis unit (not via teleconference). Each session will last 15 to 20 minutes and will be performed during clinically stable periods of dialysis. The program includes vestibulo-ocular reflex (VOR x1 and adaptation), saccadic eye movements (rapid shifts between targets), smooth pursuit (tracking moving targets), vergence (near-far focus), and integrated head-eye coordination exercises, performed in a seated position with progressive speed and complexity to enhance gaze stability and balance.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Eye exercise groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Recruitment rate
Defined as the number of enrolled participants divided by the number of eligible participants screened, expressed as a percentage.
Time frame
Baseline to 12 weeks2
Retention rate
Defined as the number of participants who complete the final post-intervention assessment divided by the number randomized, expressed as a percentage.
Time frame
Baseline to 12 weeks3
Adherence rate
Defined as the number of completed eye-exercise sessions divided by the number of planned sessions, expressed as a percentage. Session completion will be documented in an adherence log verified by weekly contact.
Time frame
Baseline to 12 weeks4
Safety and tolerability
Defined as the number, type, and severity of adverse events temporally related to the eye exercise program, including dizziness, headache, nausea, eye strain, blurred vision, or blood pressure-related symptoms.
Time frame
Baseline to 12 weeksSecondary outcomes
1
Physical function (SPPB total score)
Assessed with the Short Physical Performance Battery (SPPB), including balance stands, 4-meter gait speed, and repeated chair stands. The total score ranges from 0 to 12, with higher scores indicating better physical function.
Time frame
Baseline and 12 weeks2
Functional mobility (Timed Up and Go test)
Measured as the time in seconds required to stand from a standard chair, walk 3 meters, turn, return, and sit down. Shorter times indicate better mobility and lower mobility-related fall risk.
Time frame
Baseline and 12 weeks3
Lower-limb functional strength (30-second sit-to-stand)
Measured as the number of full sit-to-stand repetitions completed in 30 seconds from a standard chair without using the arms when possible. Higher repetition counts indicate better lower-limb strength and endurance.
Time frame
Baseline and 12 weeks4
Balance (Berg Balance Scale)
Assessed with the Berg Balance Scale, a 14-item performance-based measure of static and dynamic balance. Each item is scored on a 0-4 scale, with higher total scores indicating better balance.
Time frame
Baseline and 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov