- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05704777
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
Not yet recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
136
Phase
- 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
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Granada, Spain
- University of Granada
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Contact:
- Jesús Vera, PhD
- Phone Number: 958241904
- Email: veraj@ugr.es
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Principal Investigator:
- Amador García Ramos, PhD
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Principal Investigator:
- Jesús Vera Vilchez, PhD
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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
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 |
Intervention / Treatment |
---|---|
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.
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Usual care
A 24-weeks concurrent exercise training program
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No Intervention: control
The control group will not perform any supervised training program, and will follow standard care.
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What is the study measuring?
Primary Outcome Measures
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)
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Optical coherence tomography for the assessment of glaucomatous damage in the macula and optic nerve head
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Baseline (week 0) and after-intervention (week 25)
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Change from baseline visual fields at 6 months
Time Frame: Baseline (week 0) and after-intervention (week 25)
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Evaluation of the visual fields with the Humphrey Field Analyzer using the Swedish Interactive Thresholding Algorithm (24-2) SITA-Standard protocol .
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Baseline (week 0) and after-intervention (week 25)
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Changes from baseline anterior eye morphology and corneal biomechanics at 6 months
Time Frame: Baseline (week 0) and after-intervention (week 25)
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Assessment of the anterior chamber morphology using the Pentacam Scheimpflug camera and the biomechanics of the cornea using the Corvis ST.
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Baseline (week 0) and after-intervention (week 25)
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Change from baseline electrophysiological activity in the retina at 6 months
Time Frame: Baseline (week 0) and after-intervention (week 25)
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Examination of the functional state of the retina with the photopic negative response and pattern ERG
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Baseline (week 0) and after-intervention (week 25)
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Change from baseline intraocular pressure at 6 months
Time Frame: Baseline (week 0) and after-intervention (week 25)
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Assessment of intraocular pressure levels
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Baseline (week 0) and after-intervention (week 25)
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Change from baseline ocular perfusion pressure at 6 months
Time Frame: Baseline (week 0) and after-intervention (week 25)
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Indirect calculation of ocular perfusion pressure by the measure of intraocular pressure and blood pressure
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Baseline (week 0) and after-intervention (week 25)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported vision-targeted health status
Time Frame: Baseline (week 0) and after-intervention (week 25)
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The 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25).
Minimum value: 0 // Maximum value: 100.
Higher scores mean a better outcome.
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Baseline (week 0) and after-intervention (week 25)
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Glaucoma-specific questionnaire
Time Frame: Baseline (week 0) and after-intervention (week 25)
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The Glaucoma Symptom Scale (GSS).
Minimum value: 0 // Maximum value: 100.
Higher scores mean a better outcome.
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Baseline (week 0) and after-intervention (week 25)
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Glaucoma-related quality of life
Time Frame: Baseline (week 0) and after-intervention (week 25)
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The 15-item Glaucoma Quality of Life (GQL-15).
Minimum value: 0 // Maximum value: 100.
Higher scores mean a worse outcome.
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Baseline (week 0) and after-intervention (week 25)
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Health-related quality of life
Time Frame: Baseline (week 0) and after-intervention (week 25)
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The 36-Item Short Form Health Survey questionnaire (SF-36).
Minimum value: 0 // Maximum value: 100.
Higher scores mean a better outcome.
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Baseline (week 0) and after-intervention (week 25)
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Self-rated health in mobility, self-care, usual activities, pain/discomfort and anxiety/depression
Time Frame: Baseline (week 0) and after-intervention (week 25)
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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.
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Baseline (week 0) and after-intervention (week 25)
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Assessment of emotional (hedonic), social and psychological well-being.
Time Frame: Baseline (week 0) and after-intervention (week 25)
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The Mental Health Continuum-Short Form (MHC-SF).
Minimum value: 0 // Maximum value: 70.
Higher scores mean a better outcome.
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Baseline (week 0) and after-intervention (week 25)
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Distress evaluation along the 3 axes of depression, anxiety and stress
Time Frame: Baseline (week 0) and after-intervention (week 25)
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The Depression, Anxiety and Stress Scale short form (DASS-21).
Minimum value: 0 // Maximum value: 21.
Higher scores mean a worse outcome.
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Baseline (week 0) and after-intervention (week 25)
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Strength performance
Time Frame: Baseline (week 0) and after-intervention (week 25)
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Evaluation of the velocity recorded against submaximal loads with a linear position transducer in the squat and bench press exercises.
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Baseline (week 0) and after-intervention (week 25)
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Endurance performance
Time Frame: Baseline (week 0) and after-intervention (week 25)
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An incremental loading test will be performed on a leg crank ergometer
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Baseline (week 0) and after-intervention (week 25)
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Weight
Time Frame: Baseline (week 0) and after-intervention (week 25)
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Weight measured with a scale (kg).
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Baseline (week 0) and after-intervention (week 25)
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Fat mass
Time Frame: Baseline (week 0) and after-intervention (week 25)
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Body composition assessment will be obtained through a segmental multi-frequency body composition analyzer.
Fat mass in kg.
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Baseline (week 0) and after-intervention (week 25)
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Lean mass
Time Frame: Baseline (week 0) and after-intervention (week 25)
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Body composition assessment will be obtained through a segmental multi-frequency body composition analyzer.
Lean mass in kg.
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Baseline (week 0) and after-intervention (week 25)
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Visceral adipose tissue
Time Frame: Baseline (week 0) and after-intervention (week 25)
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Body composition assessment will be obtained through a segmental multi-frequency body composition analyzer.
Visceral adipose tissue in kg.
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Baseline (week 0) and after-intervention (week 25)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
February 1, 2023
Primary Completion (Anticipated)
December 31, 2024
Study Completion (Anticipated)
December 31, 2024
Study Registration Dates
First Submitted
December 30, 2022
First Submitted That Met QC Criteria
January 19, 2023
First Posted (Estimate)
January 30, 2023
Study Record Updates
Last Update Posted (Estimate)
January 30, 2023
Last Update Submitted That Met QC Criteria
January 19, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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