Exercise Training in Patients With Glaucoma

Glaucoma, Open-Angle Clinical Trial

— HIT GLAUCOMA  

Official title:

High Intensity Interval Training in Patients With Glaucoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06058598
• Other study ID #: 2023-01397
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: June 30, 2027

Study information

• Verified date: December 2023
• Source: University of Basel
• Contact: Henner Hanssen, Prof. Dr.
• Phone: +41 61 207 47 46
• Email: henner.hanssen[@]unibas.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: June 30, 2027
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

• Mental or physical limitation precluding participation in a high intensity exercise program

Related Conditions & MeSH terms

• Exercise Training
• Glaucoma
• Glaucoma, Open-Angle

Intervention

Other:
• Exercise Training
6-months supervised exercise training + 6 months unsupervised exercise training
• Lifestyle Counselling
12-months of lifestyle counselling

Locations

Country	Name	City	State
Switzerland	University of Basel, Department of Sport, Exercise & Health	Basel

Sponsors (3)

Lead Sponsor	Collaborator
Henner Hanssen	Universitaire Ziekenhuizen KU Leuven, University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6-months