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End Stage Renal DiseaseNCT07591714

The Effect of Intradialytic Eye Exercise in Hemodialysis Patients

A study testing Intradialytic Eye Exercise in people with End Stage Renal Disease and Hemodialysis Complication, run by Pardis Specialized Wellness Institute at 1 site in Iran.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Intradialytic Eye Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteIran
Study dates
1 Jun 2026to Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Iran1 site
  • Pardis specialized wellness institute

    Isfahan

Other trials in Iran

About this study

Official title: 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.

Read the 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.

Being tested
Intradialytic Eye Exercise
Keywords
Eye exercise, Gaze stabilization exercise, Home based exercise, Hemodialysis, Balance impairment, Fall risk, Physical function
Medical subject headings
Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intradialytic Eye ExerciseBehavioural

    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.

Study groups in NCT07591714
Study groupRoleWhat they receive
Eye exercise groupExperimentalParticipants 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).
Receives: Behavioral: Intradialytic Eye Exercise
Control groupNo interventionParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment rate

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

    Measured: Baseline to 12 weeks

  2. Retention rate

    Defined as the number of participants who complete the final post-intervention assessment divided by the number randomized, expressed as a percentage.

    Measured: Baseline to 12 weeks

  3. 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.

    Measured: Baseline to 12 weeks

  4. 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.

    Measured: Baseline to 12 weeks

Secondary outcomes (5)
  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.

    Measured: Baseline and 12 weeks

  2. 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.

    Measured: Baseline and 12 weeks

  3. 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.

    Measured: Baseline and 12 weeks

  4. 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.

    Measured: Baseline and 12 weeks

  5. 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.

    Measured: Baseline and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2026
  2. Study start1 Jun 2026
  3. Primary completionSep 2026 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomly allocated to intervention group or control group and will be examined in the same way.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07591714
Sponsor's protocol ID
PA26HD-2-01
Status last verified
Aug 2026
First submitted
9 May 2026
Last updated
1 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data (IPD) that underlie the results reported in the published article, after deidentification are to be shared

Publications

  • Son CH, Sim GW, Kim K. A Study on the Effects of a Self-Administered Eye Exercise Program on the Balance and Gait Ability of Chronic Stroke Patients: A Randomized Controlled Trial. J Pers Med. 2024 Jun 2;14(6):595. doi: 10.3390/jpm14060595.

    PubMed 38929816
  • Mueangson O, Keawmai W, Pabbumnan R, Chukaithai A, Thongdonmuean P, Vongvaivanichakul P. The Effects of Eye Exercises on Eye-Hand Coordination, Cognitive Functions and Balance Ability of the Elderly: A Randomized Controlled Trial. Int J Environ Res Public Health. 2025 Oct 14;22(10):1564. doi: 10.3390/ijerph22101564.

    PubMed 41154968
  • Asahina Y, Sakaguchi Y, Kajimoto S, Hattori K, Oka T, Kaimori JY, Kashihara N, Isaka Y. A Randomized Controlled Trial of Whole-Body Vibration on Gait Ability and Balance among Older Hemodialysis Patients. Clin J Am Soc Nephrol. 2023 Jan 1;18(1):84-90. doi: 10.2215/CJN.0000000000000018.

    PubMed 36719160
  • Finco MG, Najafi B, Zhou H, Hamad A, Ibrahim R, Al-Ali F. Game-based intradialytic non-weight-bearing exercise training on gait speed and balance in older adults with diabetes: a single-blind randomized controlled trial. Sci Rep. 2023 Aug 30;13(1):14225. doi: 10.1038/s41598-023-41290-3.

    PubMed 37648695
  • Yabe, H., Yamaguchi, T., Kono, K. et al. Effect of intradialytic exercise on fall occurrences in older patients undergoing hemodialysis: a single-center non-randomized study. Ren Replace Ther 9, 48 (2023). https://doi.org/10.1186/s41100-023-00503-1

  • Gute L, Zimbudzi E. Interventions to reduce falls among dialysis patients: a systematic review. BMC Nephrol. 2023 Dec 21;24(1):382. doi: 10.1186/s12882-023-03408-7.

    PubMed 38129770
  • Hu H, Wu C, Kwok JYY, Ho MH, Chau PH, Lok KYW, Choi EPH. Effects of Different Exercises on Physical Function, Dialysis Adequacy, and Health-Related Quality of Life in Maintenance Hemodialysis Patients: A Systematic Review and Network Meta-Analysis. Am J Nephrol. 2023;54(9-10):379-390. doi: 10.1159/000532109. Epub 2023 Aug 3.

    PubMed 37536298
  • Bogataj S, Pajek M, Kren A, Kurnik Mesaric K, Pajek J. Randomized Controlled Trial of Intradialytic Cognitive and Physical Training to Enhance Functional Capacity. Kidney Int Rep. 2024 Apr 15;9(7):2028-2036. doi: 10.1016/j.ekir.2024.04.029. eCollection 2024 Jul.

    PubMed 39081752
  • Shirai N, Morishita S, Osawa Y, Yamamoto S. Effect of increased fear of falling on falls in patients undergoing HD: A narrative review. Fukushima J Med Sci. 2025 Jan 18;71(1):13-24. doi: 10.5387/fms.24-00014. Epub 2024 Dec 12.

    PubMed 39662936
  • Tang J, Wang B, Yuan Q, Li X. Prevalence and risk factors of falls in people on hemodialysis: a systematic review and meta-analysis. Ren Fail. 2025 Dec;47(1):2485375. doi: 10.1080/0886022X.2025.2485375. Epub 2025 Apr 9.

    PubMed 40204427
  • Jesus LAS, Pinheiro BV, Gravina EPL, Silva CMB, Paticcie GF, Koufaki P, Lucinda LMF, Oliveira CC, Reboredo MM. Physical Function Tests to Assess Postural Balance in Patients on Dialysis: A Systematic Review. Hemodial Int. 2025 Oct;29(4):472-486. doi: 10.1111/hdi.13263. Epub 2025 May 30.

    PubMed 40444493
  • Takahashi R, Yabe H, Ishikawa H, Hibino T, Suzumura A, Yamada T. The Impact of Intradialytic Exercise on Activities of Daily Living and Physical Function in Hospitalized Hemodialysis Patients: A Study of Efficacy and Safety. JMA J. 2025 Jul 15;8(3):834-845. doi: 10.31662/jmaj.2024-0349. Epub 2025 Jun 6.

    PubMed 40786474
  • Correia A, Pimenta C, Alves M, Virella D. Better balance: a randomised controlled trial of oculomotor and gaze stability exercises to reduce risk of falling after stroke. Clin Rehabil. 2021 Feb;35(2):213-221. doi: 10.1177/0269215520956338. Epub 2020 Sep 9.

    PubMed 32907392

Questions about this trial

What is this clinical trial studying?

A study testing Intradialytic Eye Exercise in people with End Stage Renal Disease and Hemodialysis Complication, run by Pardis Specialized Wellness Institute at 1 site in Iran.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment rate (time frame: Baseline to 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07591714, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.

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