Exercise Intervention in Primary Open-angle Glaucoma

Study Overview
=================
Brief 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.

Official Title
-----------------
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)

Conditions
-----------------
Glaucoma, Open-Angle, Glaucoma

Intervention / Treatment
-----------------
* Behavioral: Exercise
* Other: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: exercise<br>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. | Behavioral: Exercise<br>* A 24-weeks concurrent exercise training program<br>Other: Control<br>* Usual care<br>|
| No Intervention: control<br>The control group will not perform any supervised training program, and will follow standard care. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline (week 0) and after-intervention (week 25) | 
| Change from baseline visual fields at 6 months | Evaluation of the visual fields with the Humphrey Field Analyzer using the Swedish Interactive Thresholding Algorithm (24-2) SITA-Standard protocol . | Baseline (week 0) and after-intervention (week 25) | 
| Changes from baseline anterior eye morphology and corneal biomechanics at 6 months | Assessment of the anterior chamber morphology using the Pentacam Scheimpflug camera and the biomechanics of the cornea using the Corvis ST. | Baseline (week 0) and after-intervention (week 25) | 
| Change from baseline electrophysiological activity in the retina at 6 months | Examination of the functional state of the retina with the photopic negative response and pattern ERG | Baseline (week 0) and after-intervention (week 25) | 
| Change from baseline intraocular pressure at 6 months | Assessment of intraocular pressure levels | Baseline (week 0) and after-intervention (week 25) | 
| Change from baseline ocular perfusion pressure at 6 months | Indirect calculation of ocular perfusion pressure by the measure of intraocular pressure and blood pressure | Baseline (week 0) and after-intervention (week 25) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported vision-targeted health status | The 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25). Minimum value: 0 // Maximum value: 100. Higher scores mean a better outcome. | Baseline (week 0) and after-intervention (week 25) | 
| Glaucoma-specific questionnaire | The Glaucoma Symptom Scale (GSS). Minimum value: 0 // Maximum value: 100. Higher scores mean a better outcome. | Baseline (week 0) and after-intervention (week 25) | 
| Glaucoma-related quality of life | The 15-item Glaucoma Quality of Life (GQL-15). Minimum value: 0 // Maximum value: 100. Higher scores mean a worse outcome. | Baseline (week 0) and after-intervention (week 25) | 
| Health-related quality of life | The 36-Item Short Form Health Survey questionnaire (SF-36). Minimum value: 0 // Maximum value: 100. Higher scores mean a better outcome. | Baseline (week 0) and after-intervention (week 25) | 
| Self-rated health in mobility, self-care, usual activities, pain/discomfort and anxiety/depression | 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. | Baseline (week 0) and after-intervention (week 25) | 
| Assessment of emotional (hedonic), social and psychological well-being. | The Mental Health Continuum-Short Form (MHC-SF). Minimum value: 0 // Maximum value: 70. Higher scores mean a better outcome. | Baseline (week 0) and after-intervention (week 25) | 
| Distress evaluation along the 3 axes of depression, anxiety and stress | The Depression, Anxiety and Stress Scale short form (DASS-21). Minimum value: 0 // Maximum value: 21. Higher scores mean a worse outcome. | Baseline (week 0) and after-intervention (week 25) | 
| Strength performance | Evaluation of the velocity recorded against submaximal loads with a linear position transducer in the squat and bench press exercises. | Baseline (week 0) and after-intervention (week 25) | 
| Endurance performance | An incremental loading test will be performed on a leg crank ergometer | Baseline (week 0) and after-intervention (week 25) | 
| Weight | Weight measured with a scale (kg). | Baseline (week 0) and after-intervention (week 25) | 
| Fat mass | Body composition assessment will be obtained through a segmental multi-frequency body composition analyzer. Fat mass in kg. | Baseline (week 0) and after-intervention (week 25) | 
| Lean mass | Body composition assessment will be obtained through a segmental multi-frequency body composition analyzer. Lean mass in kg. | Baseline (week 0) and after-intervention (week 25) | 
| Visceral adipose tissue | Body composition assessment will be obtained through a segmental multi-frequency body composition analyzer. Visceral adipose tissue in kg. | Baseline (week 0) and after-intervention (week 25) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exercise, Multidisciplinary intervention, Eye care