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The Effect of Intradialytic Eye Exercise in Hemodialysis Patients

31. august 2026 opdateret af: 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.

Studieoversigt

Status

Tilmelding efter invitation

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Iran
      • Isfahan, Iran
        • Pardis specialized wellness institute

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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).
Adfærdsmæssigt: 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.
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Recruitment rate
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Physical function (SPPB total score)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pardis Specialized Wellness Institute

Efterforskere

  • Studieleder: Mohammad Ali Tabibi, Dr, Study Director Pardis Specialized Wellness Institute

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juni 2026

Primær færdiggørelse (Anslået)

1. september 2026

Studieafslutning (Anslået)

1. september 2026

Datoer for studieregistrering

Først indsendt

9. maj 2026

Først indsendt, der opfyldte QC-kriterier

15. maj 2026

Først opslået (Faktiske)

18. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PA26HD-2-01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-delingstidsramme

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

IPD-delingsadgangskriterier

Not applicable. It will be accessible for public

IPD-deling Understøttende informationstype

  • SAP

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