Glaucoma Exercise as Medicine Study (GEMS).

NCT05581498 | Not Yet Recruiting

• 1 other identifier: IRB00336336
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• Change in number of VF points

  Number of VF points location measurements assess the mean defect (MD) in the top quartile for rate of change during the exercise period vs. the usual activity control period as the primary outcome variables of the study.

  Baseline, 3 months, 6 months

Secondary Outcomes (2)

• Change in ocular blood flow

  Baseline, 3 months, 6 months

• Change in ERG photopic negative response (PhNR)

  Baseline, 3 months, 6 months

Study Arms (2)

GLAUCOMA

EXPERIMENTAL

we will recruit patients with a diagnosis of primary Glaucoma for the experimental group. Exercise bikes and muscle-strength exercise belts will be used for exercise interventions.

Behavioral: Exercise, Bike exercise and muscle strength exercise.

CONTROL

ACTIVE COMPARATOR

we will recruit normally sighted older adults for the control group. Exercise bikes and muscle-strength exercise belts will be used for exercise interventions.

Behavioral: Exercise, Bike exercise and muscle strength exercise.

Interventions

Exercise, Bike exercise and muscle strength exercise. BEHAVIORAL

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.

CONTROL; GLAUCOMA

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21 40 to 80 (for glaucoma and control groups - pilot subjects must be age 21-80)
• Ability to read and respond to questions in English (facilitating GlauCAT™ questionnaire completion)
• Physician diagnosis of primary open-angle glaucoma in both eyes (glaucoma group)
• Visual field mean deviation between -5 and -15 dB (decibel) in at least one eye (glaucoma group)
• Visual acuity of 20/40 or better in both eyes (control and pilot groups)
• Normal contrast sensitivity as judged by a logCS\>1.50 in both eyes (control and pilot groups)
• Willingness to have at least 1 eye dilated at 3 prescribed study visits.

You may not qualify if:

• 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.
• 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.
• 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).
• Incisional procedures (ocular or non-ocular) in the past 6 months (minor dermatological procedures are acceptable).
• Self-report of comorbidities or orthopedic issues which would make the prescribed exercise (resistance band training and exercise bicycling) impossible.
• Current cigarette smoking or using electronic cigarettes to smoke.
• Body mass index \<18 or \>42 kg/m2.
• Current or planned pregnancy.
• 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.
• 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.
• If individuals answer no, they are eligible for the exercise intervention.
• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Eye Institute (NEI): collaborator

Related Publications (5)

• Lee MJ, Wang J, Friedman DS, Boland MV, De Moraes CG, Ramulu PY. Greater Physical Activity Is Associated with Slower Visual Field Loss in Glaucoma. Ophthalmology. 2019 Jul;126(7):958-964. doi: 10.1016/j.ophtha.2018.10.012. Epub 2018 Oct 10.

  PMID: 30315900 BACKGROUND

• Stewart KJ. Physical activity and aging. Ann N Y Acad Sci. 2005 Dec;1055:193-206. doi: 10.1196/annals.1323.029.

  PMID: 16387725 BACKGROUND

• E JY, Schrack JA, Mihailovic A, Wanigatunga AA, West SK, Friedman DS, Gitlin LN, Li T, Ramulu PY. Patterns of Daily Physical Activity across the Spectrum of Visual Field Damage in Glaucoma Patients. Ophthalmology. 2021 Jan;128(1):70-77. doi: 10.1016/j.ophtha.2020.06.053. Epub 2020 Jun 29.

  PMID: 32615202 BACKGROUND

• Zhang J, Strand K, Totillo M, Chen Q, Signorile JF, Jiang H, Wang J. Improvement of retinal tissue perfusion after circuit resistance training in healthy older adults. Exp Gerontol. 2021 Apr;146:111210. doi: 10.1016/j.exger.2020.111210. Epub 2020 Dec 29.

  PMID: 33385483 BACKGROUND

• Cardinal BJ, Esters J, Cardinal MK. Evaluation of the revised physical activity readiness questionnaire in older adults. Med Sci Sports Exerc. 1996 Apr;28(4):468-72. doi: 10.1097/00005768-199604000-00011.

  PMID: 8778552 BACKGROUND

MeSH Terms

Conditions

Glaucoma

Interventions

Exercise

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Pradeep Y Ramulu, MD, PHD

  The Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pradeep Y Ramulu, MD, PHD

CONTACT

4109551779; pramulu@jhmi.edu

Seema Banerjee, PHD

CONTACT

4432072431; sbaner14@jh.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 14, 2022
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 29, 2025

Record last verified: 2025-12