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The Effectiveness Of Home-Based Circuit Training On Eye Pressure And Eye Nerve Structures In Patients With Glaucoma

2026年7月29日 更新者:Tharani Elumalai、Universiti Sains Malaysia

The Effectiveness Of Home-Based Circuit Training On Intraocular Pressure, Retinal Nerve Fiber Layers And Choroidal Thickness In Patients With Glaucoma

The goal of this randomised control trial is to learn about the effect of home based circuit training on patients with primary glaucoma.

The main questions to answer are:

  1. Is there any difference of intraocular pressure (IOP) in patient with primary glaucoma after 6 weeks and 12 weeks who is performing home-based circuit training compared to patient not performing home-based circuit training?
  2. Is there any difference of retina nerve fibre layer in patient with primary glaucoma after 6 weeks and 12 weeks who is performing home-based circuit training compared to patient not performing home-based circuit training?
  3. Is there any difference of choroidal thickness layer in patient with primary glaucoma after 6 weeks and 12 weeks who is performing home-based circuit training compared to patient not performing home-based circuit training?

Researchers will compare patients with primary glaucoma who are performing home-based circuit training and not performing home-based circuit training to see if any affect to intraocular pressure, retina nerve fibre layer and choroidal thickness.

研究概览

地位

尚未招聘

条件

详细说明

Glaucoma is the leading cause of irreversible blindness worldwide. According to a study, it is known that East Asia has the highest number of people with glaucoma (25.20 million), followed by South- Central Asia (17.06 million) and South East Asia (6.92 million). The global prevalence of glaucoma especially in people aged 40 to 80 years is estimated to be 3.5%. The most important risk factor for glaucoma is aging. With the growing number and proportion of older population, it is projected that 111.8 million people will have glaucoma in 2040. The degeneration of retinal ganglion cells (RGCs) and their axons result in an irreversible loss of vision that has a strong correlation with increasing age. The relationship between exercise and glaucoma is complex as various components of physical activity such as fluctuations in blood pressure, body posture, and Valsalva manoeuvres can influence intraocular pressure (IOP) and ocular perfusion pressure, both of which may play roles in glaucoma pathophysiology.

The investigator would like to evaluate the effect of 12 weeks home-based circuit training on intraocular pressure (IOP), retinal nerve fibre layer thickness (RNFL) and choroidal thickness in patients with primary glaucoma. This is a randomised controlled study involving primary glaucoma patients who are attending ophthalmology clinic at Hospital Universiti Sains Malaysia. Evaluation of study sample includes baseline ocular examination, IOP and Optical Coherence Tomography Retinal Nerve Fibre Layer (OCT RNFL) and sub foveal choroidal thickness. Subjects who fulfil the inclusion and exclusion criteria for the study will be selected.

Patients in Group A will perform home-based circuit training for 12 weeks while other Group B (control group) will not perform home-based circuit training. IOP, OCT RNFL and choroidal thickness measurement will be taken at baseline, 6 weeks and 12 weeks post recruitment of subjects. All patients will be given exercise diary to note down their exercise adherence.

研究类型

介入性

注册 (估计的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Age ≥ 18 - 70 years old
  • Known case of POAG, PACG, JOAG, NTG
  • Phakic without visually significant cataract
  • Pseudophakic for more than 3 months prior to recruitment
  • Achieved target IOP
  • Physically not performing routine exercises

Exclusion Criteria:

  • Bilateral eye visual acuity of less than 6/60
  • Bilateral eye visual field defect of less than 10 degrees from fixation
  • Patient with media opacities that affect the reliability of OCT measurements such as cornea opacity, dense cataract with Lens opacification classification system (LOCS III) of more than grade 2, vitreous haemorrhage
  • Patient who underwent intraocular surgery (other than uncomplicated cataract surgery), including anti-vascular endothelial growth factor injection within past 6 months
  • Ocular disease such as cornea ulcer, uveitis, age-related macula degeneration
  • Physical disabilities such as stroke, limbs amputation
  • Uncontrolled systemic diseases eg diabetes, hypertension
  • Morbid Obesity (BMI > 40)
  • Dementia or any psychiatric diseases
  • Smoking

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:Home-Based Circuit Training
Patients in Group A will be performing home-based circuit training three times per week for 12 weeks.
Participants assigned to the intervention group will perform a home-based circuit training program in addition to receiving standard glaucoma care. The exercise program consists of seven home-based exercises, including two aerobic exercises and five resistance-based exercises performed in a circuit format. Each session will last 30 minutes for week 1-6 and 60 minutes for week 7-12. It is performed three times per week on alternate days for 12 weeks, and is conducted at moderate intensity. Participants will continue their prescribed glaucoma medications throughout the study.
无干预:Control Group
Patients in Group B will not will be performing

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Intraocular pressure
大体时间:Baseline, at 6 weeks and at 12 weeks
Baseline, at 6 weeks and at 12 weeks
Retinal Nerve Fiber Layer
大体时间:Baseline, at 6 weeks and at 12 weeks
Baseline, at 6 weeks and at 12 weeks
Choroidal Thickness
大体时间:Baseline, at 6 weeks and at 12 weeks
Baseline, at 6 weeks and at 12 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月1日

初级完成 (估计的)

2027年8月1日

研究完成 (估计的)

2027年12月1日

研究注册日期

首次提交

2026年7月24日

首先提交符合 QC 标准的

2026年7月24日

首次发布 (实际的)

2026年7月29日

研究记录更新

最后更新发布 (实际的)

2026年7月30日

上次提交的符合 QC 标准的更新

2026年7月29日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • HBCT-GLAU-2026-01

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Individual participant data (IPD) will not be shared because participant confidentiality and privacy will be protected in accordance with institutional ethics requirements and informed consent. Only aggregate study results will be published.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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