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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Universidad de Granada
- Enrollment
- 136
- Locations
- 1
- Primary Endpoint
- Change from baseline visual fields at 6 months
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Care Provider, Investigator)
Masking Description
The assessment of the outcomes will be performed by researchers blinded to the group allocation of each participant.
Eligibility Criteria
- Ages
- 50 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
exercise
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.
Intervention: Exercise (Behavioral)
exercise
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.
Intervention: Control (Other)
control
The control group will not perform any supervised training program, and will follow standard care.
Outcomes
Primary Outcomes
Change from baseline visual fields at 6 months
Time Frame: 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
Time Frame: 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
Time Frame: 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 ocular perfusion pressure at 6 months
Time Frame: Baseline (week 0) and after-intervention (week 25)
Indirect calculation of ocular perfusion pressure by the measure of intraocular pressure and blood pressure
Change from baseline intraocular pressure at 6 months
Time Frame: Baseline (week 0) and after-intervention (week 25)
Assessment of intraocular pressure levels
Change from baseline glaucomatous damage in the retina at 6 months
Time Frame: Baseline (week 0) and after-intervention (week 25)
Optical coherence tomography for the assessment of glaucomatous damage in the macula and optic nerve head
Secondary Outcomes
- Glaucoma-specific questionnaire(Baseline (week 0) and after-intervention (week 25))
- Self-reported vision-targeted health status(Baseline (week 0) and after-intervention (week 25))
- Glaucoma-related quality of life(Baseline (week 0) and after-intervention (week 25))
- Self-rated health in mobility, self-care, usual activities, pain/discomfort and anxiety/depression(Baseline (week 0) and after-intervention (week 25))
- Strength performance(Baseline (week 0) and after-intervention (week 25))
- Health-related quality of life(Baseline (week 0) and after-intervention (week 25))
- Distress evaluation along the 3 axes of depression, anxiety and stress(Baseline (week 0) and after-intervention (week 25))
- Endurance performance(Baseline (week 0) and after-intervention (week 25))
- Weight(Baseline (week 0) and after-intervention (week 25))
- Assessment of emotional (hedonic), social and psychological well-being.(Baseline (week 0) and after-intervention (week 25))
- Fat mass(Baseline (week 0) and after-intervention (week 25))
- Lean mass(Baseline (week 0) and after-intervention (week 25))
- Visceral adipose tissue(Baseline (week 0) and after-intervention (week 25))
Investigators
Jesus Vera Vilchez
Principal Investigator
Universidad de Granada