Exercise Intervention in Primary Open-angle Glaucoma (EYE-FIT)

January 19, 2023 updated by: Jesus Vera Vilchez, Universidad de Granada

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
136

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Granada, Spain
        • University of Granada
        • Contact:
          • Jesús Vera, PhD
          • Phone Number: 958241904
          • Email: veraj@ugr.es
        • Principal Investigator:
          • Amador García Ramos, PhD
        • Principal Investigator:
          • Jesús Vera Vilchez, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Other: Control
Usual care
Behavioral: Exercise
A 24-weeks concurrent exercise training program
No Intervention: control
The control group will not perform any supervised training program, and will follow standard care.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline (week 0) and after-intervention (week 25)
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 .
Baseline (week 0) and after-intervention (week 25)
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.
Baseline (week 0) and after-intervention (week 25)
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
Baseline (week 0) and after-intervention (week 25)
Change from baseline intraocular pressure at 6 months
Time Frame: Baseline (week 0) and after-intervention (week 25)
Assessment of intraocular pressure levels
Baseline (week 0) and after-intervention (week 25)
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
Baseline (week 0) and after-intervention (week 25)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Self-reported vision-targeted health status
Time Frame: Baseline (week 0) and after-intervention (week 25)
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)
Glaucoma-specific questionnaire
Time Frame: Baseline (week 0) and after-intervention (week 25)
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)
Glaucoma-related quality of life
Time Frame: Baseline (week 0) and after-intervention (week 25)
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)
Health-related quality of life
Time Frame: Baseline (week 0) and after-intervention (week 25)
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)
Self-rated health in mobility, self-care, usual activities, pain/discomfort and anxiety/depression
Time Frame: Baseline (week 0) and after-intervention (week 25)
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)
Assessment of emotional (hedonic), social and psychological well-being.
Time Frame: Baseline (week 0) and after-intervention (week 25)
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)
Distress evaluation along the 3 axes of depression, anxiety and stress
Time Frame: Baseline (week 0) and after-intervention (week 25)
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)
Strength performance
Time Frame: Baseline (week 0) and after-intervention (week 25)
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)
Endurance performance
Time Frame: Baseline (week 0) and after-intervention (week 25)
An incremental loading test will be performed on a leg crank ergometer
Baseline (week 0) and after-intervention (week 25)
Weight
Time Frame: Baseline (week 0) and after-intervention (week 25)
Weight measured with a scale (kg).
Baseline (week 0) and after-intervention (week 25)
Fat mass
Time Frame: Baseline (week 0) and after-intervention (week 25)
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)
Lean mass
Time Frame: Baseline (week 0) and after-intervention (week 25)
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)
Visceral adipose tissue
Time Frame: Baseline (week 0) and after-intervention (week 25)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad de Granada

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Durham University
University Hospital Virgen de las Nieves
University of Szczecin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 30, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2023

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2023

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PID2021-127505NA-I00 (Other Grant/Funding Number: Ministerio de Ciencia e Innovación)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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