NCT05704777

Exercise Intervention in Primary Open-angle Glaucoma

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)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: Universidad de Granada · Academic / Other
• Sex: All
• Age: 50 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Glaucoma, Open-Angle
• Glaucoma

Interventions

Type	Name	Description
BEHAVIORAL	Exercise	A 24-weeks concurrent exercise training program
OTHER	Control	Usual care

Timeline

• Start date: 2023-02-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2023-01-30
• Last updated: 2023-01-30

Locations

1 site across 1 country: Spain