Glaucoma, Open-AngleHIT GLAUCOMANCT06058598
Exercise Training in Patients With Glaucoma
A study testing Exercise Training and Lifestyle Counselling in people with Glaucoma, Open-Angle and Exercise Training, run by Henner Hanssen at 1 site in Switzerland.
Trial summary
HIT GLAUCOMA is a multicenter exercise study for glaucoma patients between three institutes: the Department of Sport, Exercise and Health (DSBG) of the University of Basel, the Eye Clinic at the University Hospital Basel and the UZ Leuven (Belgium). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Glaucoma, Open-Angle, Exercise Training, Microvascular Health
- What is being tested?
- Exercise Training and Lifestyle Counselling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Dec 2023to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary written informed consent of the participant has been obtained prior to any screening procedures
- Patients with primary open angle glaucoma (POAG), high tension glaucoma (HTG) and normal tension glaucoma (NTG), aged 40 - 75 years
- In regular follow-up in either of the two study centres
Who cannot join
- Patients having had glaucoma surgery within 6 months before start of the project
- Patients with changes in topical medication or laser trabeculoplasty within 3 months before start of the project
- Patients with very severe glaucoma (visual field mean deviation lower than -12Db)
- Significant opacification of ocular media
- Patients with life-threatening arrhythmia, signs of ischemia during CPET which preclude participation in an exercise trial
- Patients with insulin treated diabetes, chronic obstructive pulmonary disease or cancer.
- Patients doing ≥1 structured exercise training session per week or >150min of exercise/week assessed via the following two questions: a. On average, how many days per week do you engage in moderate to vigorous physical activity (like brisk walking)? b. On average, how many minutes per day do you engage in physical activity at this level? Calculate the total weekly minutes of exercise by multiplying a times b.
- Mental or physical limitation precluding participation in a high intensity exercise program
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University of Basel, Department of Sport, Exercise & Health
Basel, 4052
About this study
Official title: High Intensity Interval Training in Patients With Glaucoma
HIT GLAUCOMA is a multicenter exercise study for glaucoma patients between three institutes: the Department of Sport, Exercise and Health (DSBG) of the University of Basel, the Eye Clinic at the University Hospital Basel and the UZ Leuven (Belgium). The main objective of the study is to investigate the possibility of using exercise therapy to treat glaucoma. Participants will be randomly divided into two groups: Intervention and Control group. The intervention group will receive a high-intensity interval training plan, and the control group will receive lifestyle counseling and standard therapy. With this method, the study aims to validate an exercise therapy concept that could significantly improve disease progression and quality of life in patients with glaucoma.
Read the detailed description
Approximately 57.5 million people are affected by primary open-angle glaucoma, and it is estimated that this number will increase to 111.8 million by 2040. Despite the high prevalence and critical outlook of the disease, the pathogenesis of glaucoma is still not fully understood and treatment options remain inadequate. In particular, for glaucoma with normal intraocular pressure, there is as yet no evidence-based effective treatment option. This particular type of glaucoma may, in part, be the result of impaired microvascular endothelial function. Physical training has a proven effect on vascular health; because glaucoma involves a vascular component, positive effects of high-intensity interval training can be assumed. Thus, it could be an effective treatment for glaucoma disease.
Patients will be randomly assigned to either the intervention or control group. Patients assigned to the intervention group will participate in a 6-month exercise training program followed by a 6-months non-supervised and home-based physical activity maintenance program. During the first 6 months, patients in the intervention group participate in 18 supervised exercise sessions at the DSBG, interspersed by unsupervised exercise interventions at home.
All patients will be seen at baseline, after three months and six months of aerobic exercise training, and after another six months of physical activity and exercise self-maintenance (intervention group) or control condition. Each subject will be asked to undergo standard ophthalmic examination, non-invasive retinal assessments, peripheral blood withdrawal, and additional peripheral vascular examinations. The study design is based on regular glaucoma follow-up intervals (every 6 months) and does not intervene with clinical care and governmental reimbursement of standard care. Patients will finish their study participation after 6 months of exercise training followed by 6 months of physical activity and exercise self-maintenance or control condition.
- Being tested
- Exercise Training, Lifestyle Counselling
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise TrainingOther
6-months supervised exercise training + 6 months unsupervised exercise training
Lifestyle CounsellingOther
12-months of lifestyle counselling
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Group performing exercise training and receiving standard care Receives: Other: Exercise Training |
| Control Group | Experimental | Group receiving lifestyle counseling and receiving standard care Receives: Other: Lifestyle Counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microvascular health: retinal arteriolar and venular dilation and diameters
Retinal arteriolar and venular flicker light-induced dilation after six months; Retinal arteriolar and venular diameters after six months
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start1 Dec 2023
- Primary completion31 Mar 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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, Outcomes assessor
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henner Hanssen
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven, University Hospital, Basel, Switzerland
- Responsible party
- Sponsor-investigator, Henner Hanssen, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058598
- Sponsor's protocol ID
- 2023-01397
- Other IDs
- 2023
- Acronym
- HIT GLAUCOMA
- Status last verified
- Jul 2025
- First submitted
- 21 Sep 2023
- Last updated
- 17 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schuhmann V, Renier M, Infanger D, Fleischlin E, Van Eijgen J, Ritter ET, Jacobs T, Goetschalckx K, Gruber HJ, Kropfl J, Van Craenenbroeck AH, Gugleta K, Stalmans I, Cornelissen V, Hanssen H. Cardiorespiratory fitness, cardiovascular risk, and disease-related outcomes in primary open-angle glaucoma: a cross-sectional study. Ophthalmol Glaucoma. 2026 Sep 22:S2589-4196(26)00164-X. doi: 10.1016/j.ogla.2026.09.006. Online ahead of print.
PubMed 42772519Van Eijgen J, Schuhmann V, Fingerroos EL, Renier M, Burchert H, Kropfl JM, Van Craenenbroeck A, Cornelissen V, Gugleta K, Stalmans I, Hanssen H. High-intensity interval training in patients with glaucoma (HIT-GLAUCOMA): protocol for a multicenter randomized controlled exercise trial. Front Physiol. 2024 May 16;15:1349313. doi: 10.3389/fphys.2024.1349313. eCollection 2024.
PubMed 38818519
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Intensity Interval Training in Patients With Glaucoma
- ClinicalTrials.gov ID
- NCT06058598
- Acronym / sponsor ID
- HIT GLAUCOMA / 2023-01397
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Henner HanssenUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven, University Hospital, Basel, Switzerland
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 28 Sep 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.
HIT GLAUCOMA is a multicenter exercise study for glaucoma patients between three institutes: the Department of Sport, Exercise and Health (DSBG) of the University of Basel, the Eye Clinic at the University Hospital Basel and the UZ Leuven (Belgium). The main objective of the study is to investigate the possibility of using exercise therapy to treat glaucoma. Participants will be randomly divided into two groups: Intervention and Control group. The intervention group will receive a high-intensity interval training plan, and the control group will receive lifestyle counseling and standard therapy. With this method, the study aims to validate an exercise therapy concept that could significantly improve disease progression and quality of life in patients with glaucoma.
Detailed description
Approximately 57.5 million people are affected by primary open-angle glaucoma, and it is estimated that this number will increase to 111.8 million by 2040. Despite the high prevalence and critical outlook of the disease, the pathogenesis of glaucoma is still not fully understood and treatment options remain inadequate. In particular, for glaucoma with normal intraocular pressure, there is as yet no evidence-based effective treatment option. This particular type of glaucoma may, in part, be the result of impaired microvascular endothelial function. Physical training has a proven effect on vascular health; because glaucoma involves a vascular component, positive effects of high-intensity interval training can be assumed. Thus, it could be an effective treatment for glaucoma disease.
Patients will be randomly assigned to either the intervention or control group. Patients assigned to the intervention group will participate in a 6-month exercise training program followed by a 6-months non-supervised and home-based physical activity maintenance program. During the first 6 months, patients in the intervention group participate in 18 supervised exercise sessions at the DSBG, interspersed by unsupervised exercise interventions at home.
All patients will be seen at baseline, after three months and six months of aerobic exercise training, and after another six months of physical activity and exercise self-maintenance (intervention group) or control condition. Each subject will be asked to undergo standard ophthalmic examination, non-invasive retinal assessments, peripheral blood withdrawal, and additional peripheral vascular examinations. The study design is based on regular glaucoma follow-up intervals (every 6 months) and does not intervene with clinical care and governmental reimbursement of standard care. Patients will finish their study participation after 6 months of exercise training followed by 6 months of physical activity and exercise self-maintenance or control condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Exercise TrainingGroup performing exercise training and receiving standard care |
| Control Group | Experimental | Other: Lifestyle CounsellingGroup receiving lifestyle counseling and receiving standard care |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Voluntary written informed consent of the participant has been obtained prior to any screening procedures
- Patients with primary open angle glaucoma (POAG), high tension glaucoma (HTG) and normal tension glaucoma (NTG), aged 40 - 75 years
- In regular follow-up in either of the two study centres
Key exclusion criteria (8 listed)
- Patients having had glaucoma surgery within 6 months before start of the project
- Patients with changes in topical medication or laser trabeculoplasty within 3 months before start of the project
- Patients with very severe glaucoma (visual field mean deviation lower than -12Db)
- Significant opacification of ocular media
- Patients with life-threatening arrhythmia, signs of ischemia during CPET which preclude participation in an exercise trial
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 |
|---|---|---|
| Exercise Training6-months supervised exercise training + 6 months unsupervised exercise training | Other | Intervention Group |
| Lifestyle Counselling12-months of lifestyle counselling | Other | Control Group |
Primary outcome
Microvascular health: retinal arteriolar and venular dilation and diameters
Time frame: 6-months
Retinal arteriolar and venular flicker light-induced dilation after six months; Retinal arteriolar and venular diameters after six months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Derived from this study: PubMed 42772519Schuhmann V, Renier M, Infanger D, Fleischlin E, Van Eijgen J, Ritter ET, Jacobs T, Goetschalckx K, Gruber HJ, Kropfl J, Van Craenenbroeck AH, Gugleta K, Stalmans I, Cornelissen V, Hanssen H. Cardiorespiratory fitness, cardiovascular risk, and disease-related outcomes in primary open-angle glaucoma: a cross-sectional study. Ophthalmol Glaucoma. 2026 Sep 22:S2589-4196(26)00164-X. doi: 10.1016/j.ogla.2026.09.006. Online ahead of print.
- Derived from this study: PubMed 38818519Van Eijgen J, Schuhmann V, Fingerroos EL, Renier M, Burchert H, Kropfl JM, Van Craenenbroeck A, Cornelissen V, Gugleta K, Stalmans I, Hanssen H. High-intensity interval training in patients with glaucoma (HIT-GLAUCOMA): protocol for a multicenter randomized controlled exercise trial. Front Physiol. 2024 May 16;15:1349313. doi: 10.3389/fphys.2024.1349313. eCollection 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Training and Lifestyle Counselling in people with Glaucoma, Open-Angle and Exercise Training, run by Henner Hanssen at 1 site in Switzerland.
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 3 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 17 Dec 2025. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microvascular health: retinal arteriolar and venular dilation and diameters (time frame: 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06058598, which also lists 2 linked publications.
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 17 Dec 2025.