Glaucoma, Glaucoma, Open-Angle
Conditions
Keywords
Exercise, Multidisciplinary intervention, Eye care
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.
Interventions
BEHAVIORALExercise
A 24-weeks concurrent exercise training program
OTHERControl
Usual care
Sponsors
University Hospital Virgen de las Nieves
Durham University
University of Szczecin
Universidad de Granada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)
Masking description
The assessment of the outcomes will be performed by researchers blinded to the group allocation of each participant.
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline glaucomatous damage in the retina at 6 months | Baseline (week 0) and after-intervention (week 25) | Optical coherence tomography for the assessment of glaucomatous damage in the macula and optic nerve head |
| Change from baseline visual fields at 6 months | 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 | 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 | 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 intraocular pressure at 6 months | Baseline (week 0) and after-intervention (week 25) | Assessment of intraocular pressure levels |
| Change from baseline ocular perfusion pressure at 6 months | Baseline (week 0) and after-intervention (week 25) | Indirect calculation of ocular perfusion pressure by the measure of intraocular pressure and blood pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distress evaluation along the 3 axes of depression, anxiety and stress | Baseline (week 0) and after-intervention (week 25) | The Depression, Anxiety and Stress Scale short form (DASS-21). Minimum value: 0 // Maximum value: 21. Higher scores mean a worse outcome. |
| Strength performance | Baseline (week 0) and after-intervention (week 25) | Evaluation of the velocity recorded against submaximal loads with a linear position transducer in the squat and bench press exercises. |
| Endurance performance | Baseline (week 0) and after-intervention (week 25) | An incremental loading test will be performed on a leg crank ergometer |
| Self-reported vision-targeted health status | Baseline (week 0) and after-intervention (week 25) | The 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25). Minimum value: 0 // Maximum value: 100. Higher scores mean a better outcome. |
| Fat mass | Baseline (week 0) and after-intervention (week 25) | Body composition assessment will be obtained through a segmental multi-frequency body composition analyzer. Fat mass in kg. |
| Lean mass | Baseline (week 0) and after-intervention (week 25) | Body composition assessment will be obtained through a segmental multi-frequency body composition analyzer. Lean mass in kg. |
| Visceral adipose tissue | Baseline (week 0) and after-intervention (week 25) | Body composition assessment will be obtained through a segmental multi-frequency body composition analyzer. Visceral adipose tissue in kg. |
| Weight | Baseline (week 0) and after-intervention (week 25) | Weight measured with a scale (kg). |
| Glaucoma-specific questionnaire | Baseline (week 0) and after-intervention (week 25) | The Glaucoma Symptom Scale (GSS). Minimum value: 0 // Maximum value: 100. Higher scores mean a better outcome. |
| Glaucoma-related quality of life | Baseline (week 0) and after-intervention (week 25) | The 15-item Glaucoma Quality of Life (GQL-15). Minimum value: 0 // Maximum value: 100. Higher scores mean a worse outcome. |
| Health-related quality of life | Baseline (week 0) and after-intervention (week 25) | The 36-Item Short Form Health Survey questionnaire (SF-36). Minimum value: 0 // Maximum value: 100. Higher scores mean a better outcome. |
| Self-rated health in mobility, self-care, usual activities, pain/discomfort and anxiety/depression | Baseline (week 0) and after-intervention (week 25) | 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. |
| Assessment of emotional (hedonic), social and psychological well-being. | Baseline (week 0) and after-intervention (week 25) | The Mental Health Continuum-Short Form (MHC-SF). Minimum value: 0 // Maximum value: 70. Higher scores mean a better outcome. |
Countries
Spain
Outcome results
None listed