Exercise Intervention in Primary Open-angle Glaucoma

NCT ID: NCT05704777

Last Updated: 2023-01-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2024-12-31

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.

Conditions

Glaucoma, Open-Angle; Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

A 24-weeks concurrent exercise training program

Control

Intervention Type: OTHER

Usual care

control

The control group will not perform any supervised training program, and will follow standard care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise

A 24-weeks concurrent exercise training program

Intervention Type: BEHAVIORAL

Control

Usual care

Intervention Type: OTHER

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Virgen de las Nieves

OTHER

Sponsor Role: collaborator

Durham University

OTHER

Sponsor Role: collaborator

University of Szczecin

UNKNOWN

Sponsor Role: collaborator

Universidad de Granada

OTHER

Sponsor Role: lead

Responsible Party

Jesus Vera Vilchez

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Granada

Granada, , Spain

Countries

Spain

Facility Contacts

Jesús Vera, PhD

Role: primary

veraj@ugr.es

958241904

Other Identifiers

PID2021-127505NA-I00

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PID2021-127505NA-I00

Identifier Type: -

Identifier Source: org_study_id