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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Home-Based Circuit Training
  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. Partic

Первичные конечные точки

• Intraocular pressure [Срок оценки: Baseline, at 6 weeks and at 12 weeks]
• Retinal Nerve Fiber Layer [Срок оценки: Baseline, at 6 weeks and at 12 weeks]
• Choroidal Thickness [Срок оценки: Baseline, at 6 weeks and at 12 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Малайзия · 1 центр

• Universiti Sains Malaysia — Kubang Kerian

Публикации

• Zhu MM, Lai JSM, Choy BNK, Shum JWH, Lo ACY, Ng ALK, Chan JCH, So KF. Physical exercise and glaucoma: a review on the roles of physical exercise on intraocular pressure control, ocular blood flow regulation, neuroprotection and glaucoma-related mental health. Acta Ophthalmol. 2018 Sep;96(6):e676-e691. doi: 10.1111/aos.13661. Epub 2018 Jan 16. PMID 29338126
• Gonzalez-Devesa D, Suarez-Iglesias D, Diz JC, Esmerode-Iglesias A, Ayan C. Systematic review on the impact of exercise on intraocular pressure in glaucoma patients. Int Ophthalmol. 2024 Aug 19;44(1):351. doi: 10.1007/s10792-024-03216-4. PMID 39160282
• Anderson AJ. Exercise and Glaucoma: Positive Steps Toward Finding Another Modifiable Risk Factor to Prevent Vision Loss. Ophthalmology. 2019 Jul;126(7):965-966. doi: 10.1016/j.ophtha.2018.12.035. No abstract available. PMID 31229007
• Tribble JR, Hui F, Joe M, Bell K, Chrysostomou V, Crowston JG, Williams PA. Targeting Diet and Exercise for Neuroprotection and Neurorecovery in Glaucoma. Cells. 2021 Feb 1;10(2):295. doi: 10.3390/cells10020295. PMID 33535578
• Gildea D, Doyle A, O'Connor J. The Effect of Exercise on Intraocular Pressure and Glaucoma. J Glaucoma. 2024 Jun 1;33(6):381-386. doi: 10.1097/IJG.0000000000002411. Epub 2024 May 10. PMID 38722193

Идентификаторы

NCT: NCT07733388 · HBCT-GLAU-2026-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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