Exercise Intervention in Primary Open-angle Glaucoma

Glaucoma Clinical Trial

— EYE-FIT  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05704777
• Other study ID #: PID2021-127505NA-I00
• Secondary ID: PID2021-127505NA
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2023
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 136
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle

Intervention

Behavioral:
• Exercise
A 24-weeks concurrent exercise training program

Other:
• Control
Usual care

Locations

Country	Name	City	State
Spain	University of Granada	Granada

Sponsors (4)

Lead Sponsor	Collaborator
Universidad de Granada	Durham University, University Hospital Virgen de las Nieves, University of Szczecin

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	Change from baseline intraocular pressure at 6 months	Assessment of intraocular pressure levels	Baseline (week 0) and after-intervention (week 25)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Endurance performance	An incremental loading test will be performed on a leg crank ergometer	Baseline (week 0) and after-intervention (week 25)
Secondary	Weight	Weight measured with a scale (kg).	Baseline (week 0) and after-intervention (week 25)
Secondary	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)
Secondary	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)
Secondary	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)