Impact of Physical Activity as a Coadjuvant Strategy to Pharmacological Treatment for Glaucoma Management: A Randomized Clinical Trial in Primary Open-angle Glaucoma Patients (EYE-FIT)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Change from baseline visual fields at 6 months
研究概览
简要总结
EYE-FIT is a randomized clinical trial with a two-arm parallel design aimed at assessing the impact of performing a structured and supervised physical training program on the different variables associated with glaucoma progression in pharmacologically treated primary open angle glaucoma patients. This intervention will include a supervised 24-weeks concurrent (endurance + resistance) training program comparing its influence to the standard care.
详细描述
There are claims that more physically active individuals are less likely to glaucoma onset and progression. However, to date, there is not a single randomized controlled clinical trial assessing the impact of performing a structured and supervised physical training program on glaucoma progression. A randomized controlled clinical trial with a two-arm parallel design will be used to determine the chronic effects of a 24-weeks concurrent (endurance + resistance) training program in comparison to a control group (no training prescribed) on the ocular function and physical fitness of primary open angle glaucoma patients. Participants will be randomly divided in one of the two groups (experimental or control [wait-list]), while ocular function and physical fitness will be assessed before and after the intervention by researchers blinded to the group allocation of each participant. In addition, primary open angle glaucoma patients will be subdivided according to their medical treatment in two groups (prostaglandin analogues and combination of prostaglandin analogue and beta-blockers). Therefore, four groups will be considered in this clinical trial. The results of the EYE-FIT clinical trial will provide novel information on the influence of exercise on different markers of glaucoma, and may help to reduce the clinical, economic and social burden of this disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Investigator)
盲法说明
The assessment of the outcomes will be performed by researchers blinded to the group allocation of each participant.
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have an age between 50 and 70 years old
- •Primary open angle glaucoma diagnosis based on objective criteria (i.e., glaucomatous optic nerve head changes and visual field defects consistent with glaucoma, after the exclusion of other possible causes).
- •No have undergone any surgical intervention for glaucoma treatment
- •Be medically treated with prostaglandin analogues or with a combination of prostaglandin analogue and beta-blockers
排除标准
- •Have an scheduled surgery for the following 6 months
- •Have a sufficient level of mobility to perform supervised physical exercise
- •Suffer any disease that prevent the practice of physical exercise
结局指标
主要结局
Change from baseline visual fields at 6 months
时间窗: Baseline (week 0) and after-intervention (week 25)
Evaluation of the visual fields with the Humphrey Field Analyzer using the Swedish Interactive Thresholding Algorithm (24-2) SITA-Standard protocol .
Changes from baseline anterior eye morphology and corneal biomechanics at 6 months
时间窗: Baseline (week 0) and after-intervention (week 25)
Assessment of the anterior chamber morphology using the Pentacam Scheimpflug camera and the biomechanics of the cornea using the Corvis ST.
Change from baseline electrophysiological activity in the retina at 6 months
时间窗: Baseline (week 0) and after-intervention (week 25)
Examination of the functional state of the retina with the photopic negative response and pattern ERG
Change from baseline ocular perfusion pressure at 6 months
时间窗: Baseline (week 0) and after-intervention (week 25)
Indirect calculation of ocular perfusion pressure by the measure of intraocular pressure and blood pressure
Change from baseline intraocular pressure at 6 months
时间窗: Baseline (week 0) and after-intervention (week 25)
Assessment of intraocular pressure levels
Change from baseline glaucomatous damage in the retina at 6 months
时间窗: Baseline (week 0) and after-intervention (week 25)
Optical coherence tomography for the assessment of glaucomatous damage in the macula and optic nerve head
次要结局
- Glaucoma-specific questionnaire(Baseline (week 0) and after-intervention (week 25))
- Self-reported vision-targeted health status(Baseline (week 0) and after-intervention (week 25))
- Glaucoma-related quality of life(Baseline (week 0) and after-intervention (week 25))
- Self-rated health in mobility, self-care, usual activities, pain/discomfort and anxiety/depression(Baseline (week 0) and after-intervention (week 25))
- Strength performance(Baseline (week 0) and after-intervention (week 25))
- Health-related quality of life(Baseline (week 0) and after-intervention (week 25))
- Distress evaluation along the 3 axes of depression, anxiety and stress(Baseline (week 0) and after-intervention (week 25))
- Endurance performance(Baseline (week 0) and after-intervention (week 25))
- Weight(Baseline (week 0) and after-intervention (week 25))
- Assessment of emotional (hedonic), social and psychological well-being.(Baseline (week 0) and after-intervention (week 25))
- Fat mass(Baseline (week 0) and after-intervention (week 25))
- Lean mass(Baseline (week 0) and after-intervention (week 25))
- Visceral adipose tissue(Baseline (week 0) and after-intervention (week 25))
研究者
Jesus Vera Vilchez
Principal Investigator
Universidad de Granada