An interventional study of Intradialytic Eye Exercise in End Stage Renal Disease and Hemodialysis Complication, sponsored by Pardis Specialized Wellness Institute. Enrolling by invitation at 1 site in Iran. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Pardis Specialized Wellness Institute · Not applicable, Interventional, and Supportive care
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.
Patients receiving maintenance hemodialysis often live with deconditioning, reduced mobility, impaired balance, and substantial fall-related concern, all of which can undermine independence and daily functioning. Recent hemodialysis research has shown that poorer physical performance and greater fear of falling are strongly associated with fall risk, while recent reviews indicate that falls in this population are common and influenced by multiple interacting factors, including physical decline and reduced activity. Supervised intradialytic exercise is a logical delivery model because it can be integrated into the dialysis session, monitored directly by clinical staff, and implemented with acceptable safety and adherence in appropriately screened patients. In parallel, eye-focused training that targets oculomotor control, gaze stability, and visual-motor coordination has improved balance, gait, and fall-related confidence in other populations, including stroke survivors and older adults, suggesting a plausible mechanism for helping patients whose balance and mobility are compromised by inactivity, frailty, and treatment-related instability. However, evidence for this approach in hemodialysis remains limited, and it is not yet known whether such a program can be delivered reliably within the practical constraints of the dialysis unit without interfering with treatment. A pilot randomized trial is therefore warranted to determine feasibility, tolerability, and safety, to identify workflow barriers, and to estimate whether the intervention shows enough promise to justify a larger definitive efficacy trial.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's planned enrollment of 30 is below the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Pardis Specialized Wellness Institute is the lead sponsor of 15 studies on the registry; 3 are open to participants now.
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Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a structured eye exercise program designed to train oculomotor control, gaze stability, and eye-head coordination. The program will be delivered during in-center hemodialysis sessions (intradialytic), under supervision of trained staff or study personnel. Each session is planned for approximately 15 to 20 minutes during dialysis, 3 sessions per week for 12 weeks (36 sessions total).
Behavioral: Intradialytic Eye Exercise
Participants allocated to the control arm will receive standard nephrology care during dialysis and routine advice to maintain their usual daily activities. They will not receive the structured eye-exercise program during the intervention period.
The 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.
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 weeks
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 weeks
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 weeks
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 weeks
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 weeks
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 weeks
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 weeks
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 weeks
Fall risk / fear of falling (Falls Efficacy Scale-International)
Assessed with the 16-item Falls Efficacy Scale-International (FES-I). Each item is rated on a 4-point scale; higher total scores indicate greater concern about falling and higher perceived fall-related risk.
Time frame: Baseline and 12 weeks
Plan to share: Yes — Individual participant data (IPD) that underlie the results reported in the published article, after deidentification are to be shared
Supporting information: Statistical analysis plan
Time frame: The data will be available after the paper is published. No end date.
Access criteria: Not applicable. It will be accessible for public
Started Jun 2026 (actual). Primary completion is estimated for Sep 2026, 3 months after the start.
Of 347 non-industry interventional studies with no phase under Kidney Failure, Chronic, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 47. This study's planned 3 months is below that.
Counting every sponsor, half of 425 studies reached it within 23 months; a quarter within 8 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
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Pardis Specialized Wellness Institute