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- Ensayo clínico NCT07591714
The Effect of Intradialytic Eye Exercise in Hemodialysis Patients
31 de agosto de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Inscripción por invitación
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
30
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Isfahan, Irán
- Pardis specialized wellness institute
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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).
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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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Sin intervención: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Recruitment rate
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Physical function (SPPB total score)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Mohammad Ali Tabibi, Dr, Study Director Pardis Specialized Wellness Institute
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de junio de 2026
Finalización primaria (Estimado)
1 de septiembre de 2026
Finalización del estudio (Estimado)
1 de septiembre de 2026
Fechas de registro del estudio
Enviado por primera vez
9 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
15 de mayo de 2026
Publicado por primera vez (Actual)
18 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
31 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Procesos Patológicos
- Enfermedades urogenitales masculinas
- Enfermedades Renales
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedad crónica
- Atributos de la enfermedad
- Insuficiencia renal
- Insuficiencia Renal Crónica
- Condiciones Patológicas, Signos y Síntomas
- Insuficiencia Renal Crónica
Otros números de identificación del estudio
- PA26HD-2-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Individual participant data (IPD) that underlie the results reported in the published article, after deidentification are to be shared
Marco de tiempo para compartir IPD
The data will be available after the paper is published.
No end date.
Criterios de acceso compartido de IPD
Not applicable.
It will be accessible for public
Tipo de información de apoyo para compartir IPD
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .