The Effect of Intradialytic Eye Exercise in Hemodialysis Patients

NCT07591714 | Not Yet Recruiting DMC

• 1 other identifier: PA26HD-2-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis Complication; End Stage Renal Disease

Keywords

Eye exercise; Gaze stabilization exercise; Home based exercise; Hemodialysis; Balance impairment; Fall risk; Physical function

Outcome Measures

Primary Outcomes (4)

• Recruitment rate

  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

  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

  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

  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 Outcomes (5)

• Physical function (SPPB total score)

  Baseline and 12 weeks

• Functional mobility (Timed Up and Go test)

  Baseline and 12 weeks

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

  Baseline and 12 weeks

• Balance (Berg Balance Scale)

  Baseline and 12 weeks

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

  Baseline and 12 weeks

Study Arms (2)

Eye exercise group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

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.

Eye exercise group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pardis Specialized Wellness Institute: lead

Study Sites (1)

Pardis specialized wellness institute

Isfahan, Iran

Location

Related Publications (13)

• 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.

  PMID: 38929816 BACKGROUND

• 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.

  PMID: 41154968 BACKGROUND

• 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.

  PMID: 36719160 BACKGROUND

• 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.

  PMID: 37648695 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 38129770 BACKGROUND

• 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.

  PMID: 37536298 BACKGROUND

• 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.

  PMID: 39081752 BACKGROUND

• 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.

  PMID: 39662936 BACKGROUND

• 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.

  PMID: 40204427 BACKGROUND

• 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.

  PMID: 40444493 BACKGROUND

• 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.

  PMID: 40786474 BACKGROUND

• 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.

  PMID: 32907392 BACKGROUND

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohammad Ali Tabibi, Dr

  Study Director Pardis Specialized Wellness Institute

  STUDY DIRECTOR

Central Study Contacts

Nasrin Salimian

CONTACT

+989132-51202; statisrin@gmail.com

Mohammad Ali Tabibi, Dr

CONTACT

+989133184624; m.tabibi@ut.ac.ir

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly allocated to intervention group or control group and will be examined in the same way.

Study Record Dates

• First Submitted: May 9, 2026
• First Posted: May 18, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• 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

Locations

IR (1)