Exercise Intervention in Primary Open-angle Glaucoma

Universidad de Granada136 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

136

Conditions

Glaucoma, Open-Angle Glaucoma

Interventions

ExerciseBEHAVIORAL

A 24-weeks concurrent exercise training program

ControlOTHER

Usual care

Eligibility

Sex: ALLMin age: 50 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (1)

University of Granada

Granada, Spain

Outcomes

Primary Outcomes

Change from baseline glaucomatous damage in the retina at 6 months

Optical coherence tomography for the assessment of glaucomatous damage in the macula and optic nerve head