Glaucoma, Open-AngleEYE-FITNCT05704777
Exercise Intervention in Primary Open-angle Glaucoma
A study testing Exercise in people with Glaucoma, Open-Angle and Glaucoma, run by Universidad de Granada at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Glaucoma, Open-Angle, Glaucoma
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
University of Granada
Granada
Jesús Vera, PhD, 958241904, veraj@ugr.es
Amador García Ramos, PhD
About this study
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)
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.
Read the 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
- Being tested
- Exercise, Control
- Keywords
- Exercise, Multidisciplinary intervention, Eye care
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
A 24-weeks concurrent exercise training program
ControlOther
Usual care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Exercise; Other: Control |
| control | No intervention | The control group will not perform any supervised training program, and will follow standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 .
Measured: 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.
Measured: 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
Measured: Baseline (week 0) and after-intervention (week 25)
Change from baseline intraocular pressure at 6 months
Assessment of intraocular pressure levels
Measured: 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
Measured: Baseline (week 0) and after-intervention (week 25)
Secondary outcomes (13)
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.
Measured: Baseline (week 0) and after-intervention (week 25)
Glaucoma-specific questionnaire
The Glaucoma Symptom Scale (GSS). Minimum value: 0 // Maximum value: 100. Higher scores mean a better outcome.
Measured: Baseline (week 0) and after-intervention (week 25)
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.
Measured: Baseline (week 0) and after-intervention (week 25)
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.
Measured: Baseline (week 0) and after-intervention (week 25)
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.
Measured: Baseline (week 0) and after-intervention (week 25)
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.
Measured: Baseline (week 0) and after-intervention (week 25)
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.
Measured: Baseline (week 0) and after-intervention (week 25)
Strength performance
Evaluation of the velocity recorded against submaximal loads with a linear position transducer in the squat and bench press exercises.
Measured: Baseline (week 0) and after-intervention (week 25)
Endurance performance
An incremental loading test will be performed on a leg crank ergometer
Measured: Baseline (week 0) and after-intervention (week 25)
Weight
Weight measured with a scale (kg).
Measured: Baseline (week 0) and after-intervention (week 25)
Fat mass
Body composition assessment will be obtained through a segmental multi-frequency body composition analyzer. Fat mass in kg.
Measured: Baseline (week 0) and after-intervention (week 25)
Lean mass
Body composition assessment will be obtained through a segmental multi-frequency body composition analyzer. Lean mass in kg.
Measured: Baseline (week 0) and after-intervention (week 25)
Visceral adipose tissue
Body composition assessment will be obtained through a segmental multi-frequency body composition analyzer. Visceral adipose tissue in kg.
Measured: Baseline (week 0) and after-intervention (week 25)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start1 Feb 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Virgen de las Nieves, Durham University, University of Szczecin
- Responsible party
- Principal investigator, Jesus Vera Vilchez, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05704777
- Sponsor's protocol ID
- PID2021-127505NA-I00
- Other IDs
- PID2021-127505NA-I00
- Acronym
- EYE-FIT
- Status last verified
- Jan 2023
- First submitted
- 30 Dec 2022
- Last updated
- 30 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05704777
- Acronym / sponsor ID
- EYE-FIT / PID2021-127505NA-I00
- Conditions
- Glaucoma, Open-Angle, Glaucoma
- Keywords
- Exercise, Multidisciplinary intervention, Eye care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Collaborators
- University Hospital Virgen de las Nieves, Durham University, University of Szczecin
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise | Experimental | Behavioral: Exercise, Other: ControlThe 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. |
| control | No intervention | –The control group will not perform any supervised training program, and will follow standard care. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseA 24-weeks concurrent exercise training program | Behavioural | exercise |
| ControlUsual care | Other | exercise |
Primary outcome
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
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 .
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.
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
Change from baseline intraocular pressure at 6 months
Time frame: Baseline (week 0) and after-intervention (week 25)
Assessment of intraocular pressure levels
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
13 secondary outcomes
Self-reported vision-targeted health status
Time frame: Baseline (week 0) and after-intervention (week 25)
Glaucoma-specific questionnaire
Time frame: Baseline (week 0) and after-intervention (week 25)
Glaucoma-related quality of life
Time frame: Baseline (week 0) and after-intervention (week 25)
Health-related quality of life
Time frame: 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)
Assessment of emotional (hedonic), social and psychological well-being.
Time frame: 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)
Strength performance
Time frame: Baseline (week 0) and after-intervention (week 25)
Endurance performance
Time frame: Baseline (week 0) and after-intervention (week 25)
Weight
Time frame: Baseline (week 0) and after-intervention (week 25)
Fat mass
Time frame: Baseline (week 0) and after-intervention (week 25)
Lean mass
Time frame: Baseline (week 0) and after-intervention (week 25)
Visceral adipose tissue
Time frame: Baseline (week 0) and after-intervention (week 25)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Glaucoma, Open-Angle and Glaucoma, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline glaucomatous damage in the retina at 6 months (time frame: Baseline (week 0) and after-intervention (week 25)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2023.