The Effect of Intradialytic Eye Exercise in Hemodialysis Patients

August 31, 2026 updated by: Pardis Specialized Wellness Institute

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Iran
      • Isfahan, Iran
        • Pardis specialized wellness institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Eye exercise group
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
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.
No Intervention: Control group
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline to 12 weeks
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.
Baseline to 12 weeks
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.
Baseline to 12 weeks
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.
Baseline to 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and 12 weeks
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.
Baseline and 12 weeks
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.
Baseline and 12 weeks
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.
Baseline and 12 weeks
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.
Baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pardis Specialized Wellness Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Mohammad Ali Tabibi, Dr, Study Director Pardis Specialized Wellness Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PA26HD-2-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data (IPD) that underlie the results reported in the published article, after deidentification are to be shared

IPD Sharing Time Frame

The data will be available after the paper is published. No end date.

IPD Sharing Access Criteria

Not applicable. It will be accessible for public

IPD Sharing Supporting Information Type

  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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