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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05581498




Registration number
NCT05581498
Ethics application status
Date submitted
12/10/2022
Date registered
14/10/2022
Date last updated
1/10/2024

Titles & IDs
Public title
Glaucoma Exercise as Medicine Study (GEMS).
Scientific title
Glaucoma Exercise as Medicine Study (GEMS).
Secondary ID [1] 0 0
IRB00336336
Universal Trial Number (UTN)
Trial acronym
GEMS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glaucoma 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Exercise, Bike exercise and muscle strength exercise.

Experimental: GLAUCOMA - 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.

Active comparator: CONTROL - 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.
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.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in number of VF points
Timepoint [1] 0 0
Baseline, 3 months, 6 months
Secondary outcome [1] 0 0
Change in ocular blood flow
Timepoint [1] 0 0
Baseline, 3 months, 6 months
Secondary outcome [2] 0 0
Change in ERG photopic negative response (PhNR)
Timepoint [2] 0 0
Baseline, 3 months, 6 months

Eligibility
Key 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.
Minimum age
21 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Other
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/04/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2028
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Other
Name
Johns Hopkins University
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Eye Institute (NEI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pradeep Y Ramulu, MD, PHD
Address 0 0
The Johns Hopkins University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Pradeep Y Ramulu, MD, PHD
Address 0 0
Country 0 0
Phone 0 0
4109551779
Fax 0 0
Email 0 0
pramulu@jhmi.edu
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05581498