Exercise Intervention in Primary Open-angle Glaucoma

NCT05704777 | Unknown DMC

• 1 other identifier: PID2021-127505NA-I00
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma, Open-Angle; Glaucoma

Keywords

Exercise; Multidisciplinary intervention; Eye care

Outcome Measures

Primary Outcomes (6)

• 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)

• 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)

• 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)

• 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)

• Change from baseline intraocular pressure at 6 months

  Assessment of intraocular pressure levels

  Baseline (week 0) and after-intervention (week 25)

• 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 Outcomes (13)

• Self-reported vision-targeted health status

  Baseline (week 0) and after-intervention (week 25)

• Glaucoma-specific questionnaire

  Baseline (week 0) and after-intervention (week 25)

• Glaucoma-related quality of life

  Baseline (week 0) and after-intervention (week 25)

• Health-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)

Study Arms (2)

exercise

EXPERIMENTAL

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.

Behavioral: Exercise; Other: Control

control

NO INTERVENTION

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

Interventions

Exercise BEHAVIORAL

A 24-weeks concurrent exercise training program

exercise

Control OTHER

Usual care

exercise

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have an age between 50 and 70 years old
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Granada: lead
• University Hospital Virgen de las Nieves: collaborator
• Durham University: collaborator
• University of Szczecin: collaborator

Study Sites (1)

University of Granada

Granada, Spain

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: The assessment of the outcomes will be performed by researchers blinded to the group allocation of each participant.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 30, 2022
• First Posted: January 30, 2023
• Study Start: February 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 30, 2023

Record last verified: 2023-01

Locations

ES (1)