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The Effect of Intradialytic Eye Exercise in Hemodialysis Patients

2026年8月31日 更新者：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.

調査の概要

状態

招待による登録

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

30

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • イラン
      • Isfahan、イラン
        • Pardis specialized wellness institute

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：支持療法
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
実験的：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).
行動：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.
介入なし：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Recruitment rate
時間枠：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
時間枠：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
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Physical function (SPPB total score)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Pardis Specialized Wellness Institute

捜査官

  • スタディディレクター：Mohammad Ali Tabibi, Dr、Study Director Pardis Specialized Wellness Institute

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年6月1日

一次修了 (推定)

2026年9月1日

研究の完了 (推定)

2026年9月1日

試験登録日

最初に提出

2026年5月9日

QC基準を満たした最初の提出物

2026年5月15日

最初の投稿 (実際)

2026年5月18日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月1日

QC基準を満たした最後の更新が送信されました

2026年8月31日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • PA26HD-2-01

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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

IPD 共有時間枠

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

IPD 共有アクセス基準

Not applicable. It will be accessible for public

IPD 共有サポート情報タイプ

  • SAP

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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