Exercise Intervention in Primary Open-angle Glaucoma (EYE-FIT)

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)

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.

The assessment of the outcomes will be performed by researchers blinded to the group allocation of each participant.

The intervention (endurance + resistance training) group will perform 48 training sessions (24 weeks, twice per week). In each session, they will perform the leg and arm cycling exercises during the first half of the session (15 minutes of leg cycling and 15 minutes of arm cycling) and resistance training exercises involving the lower-body (e.g., squat) and upper-body (e.g., a variety exercises performed against the resistance imposed by elastic bands) during the second half of the session.

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

Evaluation of the visual fields with the Humphrey Field Analyzer using the Swedish Interactive Thresholding Algorithm (24-2) SITA-Standard protocol .

Assessment of the anterior chamber morphology using the Pentacam Scheimpflug camera and the biomechanics of the cornea using the Corvis ST.

Examination of the functional state of the retina with the photopic negative response and pattern ERG

Indirect calculation of ocular perfusion pressure by the measure of intraocular pressure and blood pressure

The 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25). Minimum value: 0 // Maximum value: 100. Higher scores mean a better outcome.

The Glaucoma Symptom Scale (GSS). Minimum value: 0 // Maximum value: 100. Higher scores mean a better outcome.

The 15-item Glaucoma Quality of Life (GQL-15). Minimum value: 0 // Maximum value: 100. Higher scores mean a worse outcome.

The 36-Item Short Form Health Survey questionnaire (SF-36). Minimum value: 0 // Maximum value: 100. Higher scores mean a better outcome.

The EuroQol Group inventory of 5 dimensions and 3 levels (EQ-5D-3L). Minimum value: 0 // Maximum value: 1. Higher scores mean a better outcome.

The Mental Health Continuum-Short Form (MHC-SF). Minimum value: 0 // Maximum value: 70. Higher scores mean a better outcome.

The Depression, Anxiety and Stress Scale short form (DASS-21). Minimum value: 0 // Maximum value: 21. Higher scores mean a worse outcome.

Evaluation of the velocity recorded against submaximal loads with a linear position transducer in the squat and bench press exercises.

Body composition assessment will be obtained through a segmental multi-frequency body composition analyzer. Fat mass in kg.

Body composition assessment will be obtained through a segmental multi-frequency body composition analyzer. Lean mass in kg.

Body composition assessment will be obtained through a segmental multi-frequency body composition analyzer. Visceral adipose tissue in kg.

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