End Stage Renal Disease, Hemodialysis Complication
Conditions
Keywords
Eye exercise, Gaze stabilization exercise, Home based exercise, Hemodialysis, Balance impairment, Fall risk, Physical function
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALIntradialytic Eye Exercise
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.
Sponsors
Pardis Specialized Wellness Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
A research project collaborator who is not informed about grouping of participants will obtain outcome measurements of the functional test. Outcome adjudicators, and data analysts will be kept blinded to the allocation. Moreover, all investigators, staff, and participants will be kept masked to outcome measurements and trial results.
Intervention model description
Participants will be randomly allocated to intervention group or control group and will be examined in the same way.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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 * Able to sit upright independently during dialysis * Able to complete repeated outcome assessments * Able to communicate discomfort or adverse symptoms * Usual corrective lenses permitted if needed for visual clarity
Exclusion criteria
* 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 * Severe uncorrected visual impairment or active ocular disease * Recent major ophthalmologic surgery * Severe musculoskeletal or neurologic limitations preventing participation or testing * Any condition deemed unsafe for intradialytic exercise by the treating physician or nephrologist
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | Baseline to 12 weeks | Defined as the number of enrolled participants divided by the number of eligible participants screened, expressed as a percentage. |
| Retention rate | Baseline to 12 weeks | Defined as the number of participants who complete the final post-intervention assessment divided by the number randomized, expressed as a percentage. |
| Adherence rate | Baseline to 12 weeks | 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. |
| Safety and tolerability | Baseline to 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical function (SPPB total score) | Baseline and 12 weeks | 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. |
| Functional mobility (Timed Up and Go test) | Baseline and 12 weeks | 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. |
| Lower-limb functional strength (30-second sit-to-stand) | Baseline and 12 weeks | 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. |
| Balance (Berg Balance Scale) | Baseline and 12 weeks | 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. |
| Fall risk / fear of falling (Falls Efficacy Scale-International) | Baseline and 12 weeks | 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. |
Countries
Iran
Contacts
STUDY_DIRECTORMohammad Ali Tabibi, Dr
Study Director Pardis Specialized Wellness Institute
Outcome results
None listed