Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07591714

The Effect of Intradialytic Eye Exercise in Hemodialysis Patients

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.

Recruiting

Interested in participating?

Request Info

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Intradialytic Eye Exercise

Behavioral

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.

Primary outcomes

  1. Recruitment rate

    Time frame: Baseline to 12 weeks

    Defined as the number of enrolled participants divided by the number of eligible participants screened, expressed as a percentage.

  2. Retention rate

    Time frame: 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.

  3. Adherence rate

    Time frame: 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.

  4. Safety and tolerability

    Time frame: 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 outcomes

  1. Physical function (SPPB total score)

    Time frame: 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.

  2. Functional mobility (Timed Up and Go test)

    Time frame: 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.

  3. Lower-limb functional strength (30-second sit-to-stand)

    Time frame: 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.

  4. Balance (Berg Balance Scale)

    Time frame: 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.

  5. Fall risk / fear of falling (Falls Efficacy Scale-International)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohammad Ali Tabibi, Dr

CONTACT

[email protected]

+989133184624

Nasrin Salimian

CONTACT

[email protected]

+989132-51202

Sponsors and collaborators

Lead sponsor

Pardis Specialized Wellness Institute

Other

Registry information

Official study title

The Effect of Intradialytic Eye Exercise on Physical Function, Balance, and Fall Risk in Hemodialysis Patients: A Randomized Pilot Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 18, 2026
Registry last updated
Jul 6, 2026

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.

Published trials that share one or more normalized conditions with this study.