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NCT05581498

Glaucoma Exercise as Medicine Study (GEMS).

Sponsor: Johns Hopkins University

View on ClinicalTrials.gov

Summary

Project Summary Abstract: While lifestyle changes, particularly exercise, have been suggested to protect against damage to ganglion cells in animal models, definitive evidence demonstrating its benefits in humans is lacking. Here, in a group of individuals with ganglion cell damage from glaucoma and a separate control group without significant eye disease, the investigators study the effects of a remotely delivered exercise training program by a trained exercise physiologist consisting of resistance training combined with cycling on a stationary bike. Three outcomes will be examined to evaluate if exercise might be of potential long-term benefit in protecting ganglion cells. In Aim 1, the investigators will examine the trial's primary outcome, a comparison of the pointwise change in the visual field (VF) sensitivity over the exercise period compared to a preceding usual activity period. Given the subjective nature of VF testing, Electroretinogram (ERG) testing will be employed as a more objective secondary outcome. Together, these outcomes will determine if neuro recovery is possible with exercise in individuals with GC damage from glaucoma (as has been demonstrated for Intraocular pressure (IOP)-lowering and, more recently, nicotinamide) and if neuro enhancement (improvement in the function above an already-normal level) is possible in adults without eye disease. In Aim 2, the investigators will examine if an exercise produces physiologic changes in the human eye (glaucoma and control), which would give mechanistic plausibility for a neuroprotective effect. Specifically, the investigators will compare exercise-induced changes in large vessel retinal blood flow, the density of and flux within perfused capillaries, large-vessel arterial-venous oxygen (O2) saturation gradients, inner retinal O2 metabolism, and serum levels of brain-derived neurotrophic factor (BDNF) to changes occurring in the preceding usual activity control period. Finally, in Aim 3, the investigators will examine if exercise benefits quality of life (QOL) in individuals with VF damage from glaucoma within specific domains (mobility, ocular discomfort, and mood) independent of changes in visual function. Together, these findings will provide important information regarding whether exercise produces short-term changes in eyes, which suggests possible long-term protection against ganglion cell damage.

Key Details

Gender

All

Age Range

21 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-06

Completion Date

2028-12

Last Updated

2025-12-29

Healthy Volunteers

Yes

Conditions

Glaucoma

Interventions

BEHAVIORAL

Exercise, Bike exercise and muscle strength exercise.

Study participants will perform 12 weeks of home-based exercise training with a health bike and muscle strength exercise with a resistance belt under the supervision of a certified exercise trainer. The exercise will be delivered 3 days a week for 75 minutes for 12 weeks.

Inclusion Criteria: 1. Age 21 40 to 80 (for glaucoma and control groups - pilot subjects must be age 21-80) 2. Ability to read and respond to questions in English (facilitating GlauCAT™ questionnaire completion) 3. Physician diagnosis of primary open-angle glaucoma in both eyes (glaucoma group) 4. Visual field mean deviation between -5 and -15 dB (decibel) in at least one eye (glaucoma group) 5. Visual acuity of 20/40 or better in both eyes (control and pilot groups) 6. Normal contrast sensitivity as judged by a logCS\>1.50 in both eyes (control and pilot groups) 7. Willingness to have at least 1 eye dilated at 3 prescribed study visits. Exclusion Criteria: 1. The presence of self-reported or chart-recorded significant comorbid eye conditions in either eye, including diabetic retinopathy, retinal detachment, uveitis, retinal artery or vein occlusion, central serous retinopathy, amblyopia, or optic neuropathy other than glaucoma. 2. Individuals will also be excluded from the control group if they have a history of self-reported or chart-recorded glaucoma, suspect glaucoma, or ocular hypertension. Individuals with less serious conditions (dry eye, early cataract, mild posterior capsular opacification, mild epiretinal membranes, allergic conjunctivitis, pinguecula, etc.) will be allowed into the study if they meet the visual criteria above. 3. Uncontrolled blood pressure (BP), with systolic blood pressure (SBP) BP\>160 or diastolic blood pressure (DBP) BP\>100 at the first study visit (with or without anti-hypertensive medications). 4. Incisional procedures (ocular or non-ocular) in the past 6 months (minor dermatological procedures are acceptable). 5. Self-report of comorbidities or orthopedic issues which would make the prescribed exercise (resistance band training and exercise bicycling) impossible. 6. Current cigarette smoking or using electronic cigarettes to smoke. 7. Body mass index \<18 or \>42 kg/m2. 8. Current or planned pregnancy. 9. Self-report moderate or vigorous activity for more than 90 minutes weekly. Activities classified as moderate/vigorous include running, swimming, resistance training, most sports (basketball, volleyball, tennis), walking briskly (15' per mile), bicycling, active gardening, aerobics, or other similar activities. 10. Suitability for exercise will be confirmed by administering the Physical Activity (PA) Readiness Questionnaire Plus (PAR-Q+), a two-part questionnaire in which individuals can be categorized as fit for exercise. In the first part of the questionnaire, patients are asked 7 questions regarding self-reported: (1) heart disease/high blood pressure, (2) chest pain at rest or with activity, (3) poor balance, dizziness or loss of consciousness, (4) chronic medical conditions other than heart disease, (5) medications for chronic medical conditions, (6) bone or joint problems that could worsen with physical activity, or (7) being told by a doctor that they should only do medically-supervised physical activity. 11. If individuals answer no, they are eligible for the exercise intervention. 12. If they answer yes, they are asked several additional, more detailed questions to gauge the severity of their conditions (i.e., arthritis requiring steroid injections or tablets, cancer requiring active chemotherapy, chronic heart failure, etc.). If they answer yes to any of these questions, they will be excluded from study participation. 13. As some exclusion criteria (blood pressure, body-mass index, PAR-Q+ scores) are obtained after the consent, the numbers consenting and proceeding to the test will differ.