Clinical trial NCT05704777: Exercise Intervention in Primary Open-angle Glaucoma
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glaucoma, Open-Angle
Glaucoma
Keywords: Exercise
Multidisciplinary intervention
Eye care
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
Collaborators: name: University Hospital Virgen de las Nieves
name: Durham University
name: University of Szczecin
First posted: 2023-01-30
Enrollment: 136
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline glaucomatous damage in the retina at 6 months
timeFrame: Baseline (week 0) and after-intervention (week 25)
measure: Change from baseline visual fields at 6 months
timeFrame: Baseline (week 0) and after-intervention (week 25)
measure: Changes from baseline anterior eye morphology and corneal biomechanics at 6 months
timeFrame: Baseline (week 0) and after-intervention (week 25)
measure: Change from baseline electrophysiological activity in the retina at 6 months
timeFrame: Baseline (week 0) and after-intervention (week 25)
measure: Change from baseline intraocular pressure at 6 months
timeFrame: Baseline (week 0) and after-intervention (week 25)
measure: Change from baseline ocular perfusion pressure at 6 months
timeFrame: Baseline (week 0) and after-intervention (week 25)
Secondary outcomes:
measure: Self-reported vision-targeted health status
timeFrame: Baseline (week 0) and after-intervention (week 25)
measure: Glaucoma-specific questionnaire
timeFrame: Baseline (week 0) and after-intervention (week 25)
measure: Glaucoma-related quality of life
timeFrame: Baseline (week 0) and after-intervention (week 25)
measure: Health-related quality of life
timeFrame: Baseline (week 0) and after-intervention (week 25)
measure: Self-rated health in mobility, self-care, usual activities, pain/discomfort and anxiety/depression
timeFrame: Baseline (week 0) and after-intervention (week 25)
measure: Assessment of emotional (hedonic), social and psychological well-being.
timeFrame: Baseline (week 0) and after-intervention (week 25)
measure: Distress evaluation along the 3 axes of depression, anxiety and stress
timeFrame: Baseline (week 0) and after-intervention (week 25)
measure: Strength performance
timeFrame: Baseline (week 0) and after-intervention (week 25)
measure: Endurance performance
timeFrame: Baseline (week 0) and after-intervention (week 25)
measure: Weight
timeFrame: Baseline (week 0) and after-intervention (week 25)
measure: Fat mass
timeFrame: Baseline (week 0) and after-intervention (week 25)
measure: Lean mass
timeFrame: Baseline (week 0) and after-intervention (week 25)
measure: Visceral adipose tissue
timeFrame: Baseline (week 0) and after-intervention (week 25)
Other outcomes:
Locations:
city: Granada
country: Spain
facility: University of Granada
Study officials:
References: