- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07591714
The Effect of Intradialytic Eye Exercise in Hemodialysis Patients
31. srpna 2026 aktualizováno: 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.
Přehled studie
Postavení
Zápis na pozvánku
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Odhadovaný)
30
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Isfahan, Írán
- Pardis specialized wellness institute
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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).
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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.
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Žádný zásah: 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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Recruitment rate
Časové okno: Baseline to 12 weeks
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Defined as the number of enrolled participants divided by the number of eligible participants screened, expressed as a percentage.
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Baseline to 12 weeks
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Retention rate
Časové okno: Baseline to 12 weeks
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Defined as the number of participants who complete the final post-intervention assessment divided by the number randomized, expressed as a percentage.
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Baseline to 12 weeks
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Adherence rate
Časové okno: Baseline to 12 weeks
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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.
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Baseline to 12 weeks
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Safety and tolerability
Časové okno: Baseline to 12 weeks
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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.
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Baseline to 12 weeks
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Physical function (SPPB total score)
Časové okno: Baseline and 12 weeks
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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.
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Baseline and 12 weeks
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Functional mobility (Timed Up and Go test)
Časové okno: Baseline and 12 weeks
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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.
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Baseline and 12 weeks
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Lower-limb functional strength (30-second sit-to-stand)
Časové okno: Baseline and 12 weeks
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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.
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Baseline and 12 weeks
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Balance (Berg Balance Scale)
Časové okno: Baseline and 12 weeks
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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.
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Baseline and 12 weeks
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Fall risk / fear of falling (Falls Efficacy Scale-International)
Časové okno: Baseline and 12 weeks
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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.
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Baseline and 12 weeks
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Ředitel studie: Mohammad Ali Tabibi, Dr, Study Director Pardis Specialized Wellness Institute
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. června 2026
Primární dokončení (Odhadovaný)
1. září 2026
Dokončení studie (Odhadovaný)
1. září 2026
Termíny zápisu do studia
První předloženo
9. května 2026
První předloženo, které splnilo kritéria kontroly kvality
15. května 2026
První zveřejněno (Aktuální)
18. května 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
1. září 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
31. srpna 2026
Naposledy ověřeno
1. srpna 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Urogenitální onemocnění
- Patologické procesy
- Mužská urogenitální onemocnění
- Onemocnění ledvin
- Urologická onemocnění
- Ženské urogenitální onemocnění
- Ženské urogenitální onemocnění a těhotenské komplikace
- Chronické onemocnění
- Atributy nemoci
- Renální insuficience
- Renální insuficience, chronická
- Patologické stavy, příznaky a symptomy
- Selhání ledvin, chronické
Další identifikační čísla studie
- PA26HD-2-01
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
Individual participant data (IPD) that underlie the results reported in the published article, after deidentification are to be shared
Časový rámec sdílení IPD
The data will be available after the paper is published.
No end date.
Kritéria přístupu pro sdílení IPD
Not applicable.
It will be accessible for public
Typ podpůrných informací pro sdílení IPD
- MÍZA
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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