The Effectiveness Of Home-Based Circuit Training On Intraocular Pressure, Retinal Nerve Fiber Layers And Choroidal Thickness In Patients With Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Retinal Nerve Fiber Layer
研究概览
简要总结
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:
- 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?
- 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?
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Retinal Nerve Fiber Layer
时间窗: Baseline, at 6 weeks and at 12 weeks
Choroidal Thickness
时间窗: Baseline, at 6 weeks and at 12 weeks
Intraocular pressure
时间窗: Baseline, at 6 weeks and at 12 weeks
次要结局
未报告次要终点
研究者
Tharani Elumalai
Principal Investigator
Universiti Sains Malaysia